Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05434520
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2022-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relieving the Bile Ducts Prior to Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D001658', 'term': 'Biliary Fistula'}], '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'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 722}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-26', 'studyFirstSubmitDate': '2022-05-28', 'studyFirstSubmitQcDate': '2022-06-26', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative complication score (Clavien-Dindo)', 'timeFrame': 'During hospital admission, median time 13 days, up to 390 days.', 'description': 'The prevalence of complications graded according to Clavien-Dindo score after pancreatoduodenectomy. Clavien-Dindo 0 is no complications, Clavien-Dindo 5 means complications resulting in mortality.'}, {'measure': '30-day Mortality', 'timeFrame': 'up to 30 days', 'description': '30-day mortality rate post-pancreatoduodenectomy'}, {'measure': '90-day Mortality', 'timeFrame': 'up to 90 days', 'description': '90-day mortality rate post-pancreatoduodenectomy'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Days from admission until discharge, up to 390 days, median time 13 days', 'description': 'Accumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge.'}, {'measure': '30-day Readmission', 'timeFrame': 'up to 30-days from hospital discharge', 'description': 'Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy.'}], 'secondaryOutcomes': [{'measure': 'Complications following preoperative bile duct drainage', 'timeFrame': 'up to 7 days after bile duct drainage', 'description': 'Prevalence of cholangitis, pancreatitis, iatrogenic perforation, post-procedural bleeding and post-procedural thrombosis'}, {'measure': 'Time from Bile Duct Drainage to Pancreatoduodenectomy', 'timeFrame': 'Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days', 'description': 'Time from Bile Duct Decompression to pancreatoduodenectomy.'}, {'measure': 'Histological Specimen', 'timeFrame': 'Obtained within 21 days after resection', 'description': 'Histological diagnosis of the resection specimens divided in malignant (ductal adenocarcinoma, cholangiocarcinoma, papillary carcinoma, duodenal adenocarcinoma, neuroendocrine tumor, other pancreatic carcinoma, other malignancy in the pancreas) and benign (IPMN, other benign diseases).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatoduodenectomy', 'complications', 'percutaneous transhepatic biliary drainage'], 'conditions': ['Pancreas Cancer', 'Surgery-Complications', 'Biliary Fistula']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.\n\nA retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.', 'detailedDescription': 'Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.\n\nA retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who had undergone pancreatoduodenectomy from January 1st, 2015 to September 31, 2021', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who had undergone pancreatoduodenectomy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05434520', 'briefTitle': 'Relieving the Bile Ducts Prior to Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Relieving the Bile Ducts Prior to Pancreatoduodenectomy', 'orgStudyIdInfo': {'id': 'PDPTC1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preoperative biliary drainage', 'description': 'Patients who had undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy', 'interventionNames': ['Procedure: Preoperative biliary drainage (ERC og PTC-aided)']}, {'label': 'No preoperative biliary drainage', 'description': 'Patients who had not undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy'}], 'interventions': [{'name': 'Preoperative biliary drainage (ERC og PTC-aided)', 'type': 'PROCEDURE', 'description': 'Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC', 'armGroupLabels': ['Preoperative biliary drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capitol', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The datasets generated and/or analyzed during the current study are not publicly available due to a restriction agreement with the Danish Data Protection Agency but are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Waqas Farooqui', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}