Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-27 @ 9:36 PM
Study NCT ID:
NCT01441492
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2011-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pancreas Resection With and Without Drains
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pancreas@bcm.edu', 'phone': '7137981016', 'title': 'Amy McElhany, Clinical Research Manager', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A potential weakness of the current study is that it took 5 years to reach targeted accrual.'}}, 'adverseEventsModule': {'timeFrame': '30 days and 60 days', 'eventGroups': [{'id': 'EG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.', 'otherNumAtRisk': 170, 'otherNumAffected': 99, 'seriousNumAtRisk': 170, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).', 'otherNumAtRisk': 174, 'otherNumAffected': 130, 'seriousNumAtRisk': 174, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pancreatic_leak_fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Postoperative_Abdominal_FluidCollection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Biliary_leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Enteric_leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymph_Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroparesis_DelayedGastricEmptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'SmallBowelObstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Intra_abd_abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wound_Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wound_Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Grade 3 intra-abdominal infection and pancreatic leak/fistula', 'notes': 'Both SAEs were categorized as grade 3 or higher complications. Both patients were assigned to the "No Drain Group" and developed a grade 3 intra-abdominal infection and pancreatic leak/fistula.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '60-day ≥ Grade II Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.804', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '60-day ≥ Grade III Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Event (SAE) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Complication Severity Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'title': 'All patients', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'For just the patients with complications', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60 days', 'description': 'This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced', 'unitOfMeasure': 'severity grade', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '60-day Frequency of Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60 days', 'description': 'This is the median number of complications per patients.', 'unitOfMeasure': 'Complications per patient', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '90-day Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Specific Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients who will not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients who will receive drains, the standard of care treatment, following pancreas resection.\n\nDrains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'title': 'Pancreatic_leak_fistula', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative_Abdominal_FluidCollection', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Biliary_leak', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Enteric_leak', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymph_Leak', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Gastroparesis_DelayedGastricEmptying', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'SmallBowelObstruction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Seroma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Intra_abd_abscess', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Wound_Dehiscence', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Wound_Infection', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay for the Index Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60 days', 'description': 'This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Crude Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients who will not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients who will receive drains, the standard of care treatment, following pancreas resection.\n\nDrains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'timeFrame': '60 days', 'description': 'This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for analysis'}, {'type': 'SECONDARY', 'title': 'Composite Quality of Life Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Drains', 'description': 'Patients who will not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'OG001', 'title': 'Drains', 'description': 'Patients who will receive drains, the standard of care treatment, following pancreas resection.\n\nDrains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'classes': [{'title': 'Physical well-being subscale', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '27'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '24'}]}]}, {'title': 'Social/Family well-being subscale', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '22'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '22'}]}]}, {'title': 'Emotional well-being subscale', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '23'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '23'}]}]}, {'title': 'Functional well-being subscale', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '22'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '21'}]}]}, {'title': 'Total FACT-G score', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '88'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '87'}]}]}, {'title': 'FACT-Pa subscale', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '29'}]}]}, {'title': 'Total FACT-Pa score', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '114'}, {'value': '105', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '116'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days and 60 days', 'description': 'Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis.\n\nThe Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0\\~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0\\~144. A lower score represents the worst quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The result is the quality of score at 30 days.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'FG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '202'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Drains', 'description': 'Patients did not receive intraperitoneal drainage following pancreas resection.\n\nNo Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.'}, {'id': 'BG001', 'title': 'Drains', 'description': 'Patients did receive drain(s), the standard of care treatment, following pancreas resection.\n\nDrains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '73'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '73'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '48', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2011-09-23', 'resultsFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2011-09-26', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-27', 'studyFirstPostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '60-day ≥ Grade II Complication Rate', 'timeFrame': '60 days', 'description': 'The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.'}], 'secondaryOutcomes': [{'measure': '60-day ≥ Grade III Complication Rate', 'timeFrame': '60 days', 'description': 'This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.'}, {'measure': 'Serious Adverse Event (SAE) Rate', 'timeFrame': '60 days', 'description': 'This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.'}, {'measure': 'Median Complication Severity Grade', 'timeFrame': '60 days', 'description': 'This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced'}, {'measure': '60-day Frequency of Complications', 'timeFrame': '60 days', 'description': 'This is the median number of complications per patients.'}, {'measure': '90-day Mortality Rate', 'timeFrame': '90 days'}, {'measure': 'Rate of Specific Complications', 'timeFrame': '60 days', 'description': 'The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).'}, {'measure': 'Length of Stay for the Index Admission', 'timeFrame': '60 days', 'description': 'This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.'}, {'measure': 'Crude Cost', 'timeFrame': '60 days', 'description': 'This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.'}, {'measure': 'Composite Quality of Life Scores', 'timeFrame': '30 days and 60 days', 'description': 'Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis.\n\nThe Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0\\~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0\\~144. A lower score represents the worst quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Distal pancreatectomy', 'Pancreas resection'], 'conditions': ['Pancreas Tumor', 'Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '21689234', 'type': 'BACKGROUND', 'citation': 'Fisher WE, Hodges SE, Silberfein EJ, Artinyan A, Ahern CH, Jo E, Brunicardi FC. Pancreatic resection without routine intraperitoneal drainage. HPB (Oxford). 2011 Jul;13(7):503-10. doi: 10.1111/j.1477-2574.2011.00331.x.'}, {'pmid': '24374513', 'type': 'BACKGROUND', 'citation': 'Van Buren G 2nd, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, Vollmer C, Velanovich V, Riall T, Muscarella P, Trevino J, Nakeeb A, Schmidt CM, Behrns K, Ellison EC, Barakat O, Perry KA, Drebin J, House M, Abdel-Misih S, Silberfein EJ, Goldin S, Brown K, Mohammed S, Hodges SE, McElhany A, Issazadeh M, Jo E, Mo Q, Fisher WE. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460.'}], 'seeAlsoLinks': [{'url': 'https://www.bcm.edu/healthcare/care-centers/pancreas-center', 'label': 'Elkins Pancreas Center'}]}, 'descriptionModule': {'briefSummary': 'This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.', 'detailedDescription': 'The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula.\n\nHypothesis:\n\nThis randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.\n\nObjectives:\n\nPrimary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nSecondary:\n\nA. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nB. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nC. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nD. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nE. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nF. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nG. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nH. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.\n\nI. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject has a surgical indication for distal pancreatectomy.\n* In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy.\n* At least 18 years of age.\n* The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group.\n* The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.\n\nExclusion Criteria:\n\n* The subject does not have a surgical indication for distal pancreatectomy.\n* In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy.\n* Less than 18 years of age.\n* The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group.\n* The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.'}, 'identificationModule': {'nctId': 'NCT01441492', 'briefTitle': 'Pancreas Resection With and Without Drains', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage', 'orgStudyIdInfo': {'id': 'H-28324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No Drains', 'description': 'Patients who will not receive intraperitoneal drainage following pancreas resection.', 'interventionNames': ['Procedure: No Drains']}, {'type': 'EXPERIMENTAL', 'label': 'Drains', 'description': 'Patients who will receive drains, the standard of care treatment, following pancreas resection.', 'interventionNames': ['Procedure: Drains']}], 'interventions': [{'name': 'No Drains', 'type': 'PROCEDURE', 'description': 'A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.', 'armGroupLabels': ['No Drains']}, {'name': 'Drains', 'type': 'PROCEDURE', 'otherNames': ['The specific brand of drain is not contolled.'], 'description': 'A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).', 'armGroupLabels': ['Drains']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University - Purdue University Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop-University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29424', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77338', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'William E Fisher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery', 'investigatorFullName': 'William E Fisher', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}