Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-03-03 @ 2:41 PM
Study NCT ID:
NCT02517268
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2015-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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': 'D016577', 'term': 'Pancreaticoduodenectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Harish.Lavu@jefferson.edu', 'phone': '215-955-6888', 'title': 'Dr. Harish Lavu', 'organization': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'baseline to 3 months after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 17, 'seriousNumAtRisk': 39, 'deathsNumAffected': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 5, 'seriousNumAtRisk': 37, 'deathsNumAffected': 13, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pancreatic Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Delayed Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Discharged by Post-operative Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy'}, {'id': 'OG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to post-operative day 5', 'description': 'Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-operative Median Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy'}, {'id': 'OG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '23'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days after operation', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy'}, {'id': 'OG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '155,542', 'groupId': 'OG000', 'lowerLimit': '125,519', 'upperLimit': '398,764'}, {'value': '139,735', 'groupId': 'OG001', 'lowerLimit': '104,689', 'upperLimit': '253,830'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days after operation', 'description': 'Cost will be assessed by reviewing inpatient hospital charges', 'unitOfMeasure': 'US Dollar', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Readmission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy'}, {'id': 'OG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after operation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy'}, {'id': 'OG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy'}], 'classes': [{'title': 'Delayed Gastric Emptying (DGE)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Anastomotic leaks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'intra-abdominal abscess', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Wound Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Tract Infection (UTI)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic Fistula', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Renal Failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after operation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy'}, {'id': 'FG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '22 participants were not included in the final analysis as they were not randomized to either arm of the study. Prior to randomization, 3 participants withdrew consent, and 19 participants did not undergo their procedure at Thomas Jefferson University Hospital', 'preAssignmentDetails': '22 participants were not included in the final analysis as they were not randomized to either arm of the study. Prior to randomization, 3 participants withdrew consent, and 19 participants did not undergo their procedure at Thomas Jefferson University Hospital. On the control arm, 1 participant withdrew consent after randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy\n\nPancreaticoduodenectomy'}, {'id': 'BG001', 'title': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nPancreaticoduodenectomy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '70', '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': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-24', 'size': 1516534, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-27T07:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2015-07-30', 'resultsFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-04', 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Discharged by Post-operative Day 5', 'timeFrame': 'Up to post-operative day 5', 'description': 'Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5'}], 'secondaryOutcomes': [{'measure': 'Post-operative Median Length of Stay', 'timeFrame': '30 days after operation'}, {'measure': 'Cost', 'timeFrame': '30 days after operation', 'description': 'Cost will be assessed by reviewing inpatient hospital charges'}, {'measure': 'Readmission Rate', 'timeFrame': '30 days after operation'}, {'measure': 'Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)', 'timeFrame': '30 days after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Carcinoma']}, 'referencesModule': {'references': [{'pmid': '30660818', 'type': 'DERIVED', 'citation': 'Lavu H, McCall NS, Winter JM, Burkhart RA, Pucci M, Leiby BE, Yeo TP, Cannaday S, Yeo CJ. Enhancing Patient Outcomes while Containing Costs after Complex Abdominal Operation: A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway. J Am Coll Surg. 2019 Apr;228(4):415-424. doi: 10.1016/j.jamcollsurg.2018.12.032. Epub 2019 Jan 17.'}], 'seeAlsoLinks': [{'url': 'http://www.KimmelCancerCenter.org', 'label': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center'}, {'url': 'http://hospitals.jefferson.edu/', 'label': 'Jefferson University Hospitals'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies accelerated recovery pathway for discharge after surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may improve outcomes after surgery following complex abdominal operations resulting in a shorter length of stay in patients with pancreatic cancer. It may also help patients to mobilize more quickly and return to the home setting, decrease hospital-acquired infectious complications, and increase potential cost savings. It is not yet known whether an accelerated recovery pathway is better than a standard recovery pathway for discharge following surgery in patients with pancreatic cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. The use of an accelerated pathway will result in a shorter postoperative hospital length of stay for patients undergoing pancreaticoduodenectomy (PD) without an increase in perioperative complications or readmission rates.\n\nSECONDARY OBJECTIVES:\n\nI. The investigators anticipate lower cost, lower readmission rate, similar rate of post-operative complications (delayed gastric emptying \\[DGE\\], anastomotic leaks, intra-abdominal abscesses, wound infection, urinary tract infection \\[UTI\\], respiratory compromise, renal failure, etc.) in our study group.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients follow the standard 7-day pathway at the end of surgery.\n\nARM II: Patients follow the Whipple accelerated 5-day pathway at the end of surgery. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.\n\nAfter completion of study treatment, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pancreaticoduodenectomy\n2. Firm gland texture\n3. Subjects able to provide informed consent\n\nExclusion Criteria:\n\n1. Preoperative factors:\n\n * Congestive heart failure (CHF)\n * End stage renal disease (ESRD)\n * Chronic obstructive pulmonary disease (COPD)\n * Pregnancy\n * Albumin \\< 3 gm/dL\n * Poor preoperative performance status as defined by: timed get up and go (\\< 15 seconds)\n * Patients cannot be homeless or have substance dependence\n2. Intraoperative factors:\n\n * Estimated blood loss (EBL) \\> 1 liter\n * Failure to extubate at the conclusion of the case\n * Operative time \\> 8 hours\n * Need for vascular resection/reconstruction'}, 'identificationModule': {'nctId': 'NCT02517268', 'acronym': 'WARP', 'briefTitle': 'Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)', 'orgStudyIdInfo': {'id': '15D.050'}, 'secondaryIdInfos': [{'id': '2014-082', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': 'JT 6901', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard 7-Day Pathway', 'description': 'Patients follow the standard 7-day pathway following pancreaticoduodenectomy', 'interventionNames': ['Procedure: Pancreaticoduodenectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Accelerated 5-Day Pathway', 'description': 'Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.', 'interventionNames': ['Procedure: Pancreaticoduodenectomy']}], 'interventions': [{'name': 'Pancreaticoduodenectomy', 'type': 'PROCEDURE', 'otherNames': ['Pancreatoduodenectomy', 'Whipple procedure', 'Kausch-Whipple procedure'], 'armGroupLabels': ['Accelerated 5-Day Pathway', 'Standard 7-Day Pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Harish Lavu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}