Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-04 @ 10:04 AM
Study NCT ID:
NCT02457156
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of post-operative pancreatic fistula', 'timeFrame': 'Assessed up to 3 months after surgery.', 'description': 'Post-operative pancreatic fistula are defined as any abnormal connection between the pancreatic duct epithelium and another epithelised surface, which contains pancreatic derived, enzyme rich fluid. This will be assessed up to 3 months following surgery on inpatient days 3-7, day of discharge (expected to be 1 - 5 weeks after surgery) and 3 month follow up.'}], 'secondaryOutcomes': [{'measure': 'Entry into programs of adjuvent therapy', 'timeFrame': '3, 6 and 12 month follow up'}, {'measure': 'Mortality Rate', 'timeFrame': 'Death due to any cause during the study will be recorded'}, {'measure': 'Rate of delayed gastric emptying', 'timeFrame': 'Post operative day 3, 5, 7, and the day of discharge, which is expected to be between 1 - 5 weeks after surgery.'}, {'measure': 'Rate of wound infections', 'timeFrame': 'Post operative day 3, 5, 7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3, 6 and 12 month follow up'}, {'measure': 'Rate of pulmonary infection', 'timeFrame': 'The day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow up.'}, {'measure': 'Rate of post-operative fluid collections', 'timeFrame': 'post operative days 3-7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow-up'}, {'measure': 'Operation time', 'timeFrame': 'Day of surgery'}, {'measure': 'Rate of intra and post-operative bleeding', 'timeFrame': 'day of surgery, post operaive day 3, 5, 7 and the day of discharge, which is expected to be between 1 - 5 weeks after surgery'}, {'measure': 'Rate of re-operation', 'timeFrame': 'Up to 12 months after surgery'}, {'measure': 'Rate of venous thrombo-embolism', 'timeFrame': 'Post operative day 3, 5, 7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow up'}, {'measure': 'Length of hospital stay', 'timeFrame': 'The day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up'}, {'measure': 'Quality of Life measured by the QLQ-C30 questionnaire', 'timeFrame': 'Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up'}, {'measure': 'Health economic evaluation measured by the EQ-5D questionnaire', 'timeFrame': 'Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pancreatico-jejunostomy', 'Pancreato-duodenectomy', 'Cattell-Warren anastomosis', 'Blumgart anastomosis'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different techniques of performing a pancreatic anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces pancreatic remnant leak, post-operative complications and overall length of hospital stay.', 'detailedDescription': 'This is a randomised controlled, phase III, double blinded, multicentre clinical trial comparing Cattell-Warren (CWA) versus. Blumgart (BA) methods of pancreaticojejunostomy following pancreaticduodenectomy for supected malignancy of the pancreatic head.\n\nThe primary objective of the trial is to establish if the Blumgart anastomosis reduces pancreatic remnant leak and in turn complications, hospital stay, cost and promote enhanced recorvery programs.\n\n506 patients (253 patients per treatment arm) will be recruited from approximately 7 centres throughout the United Kingdom.\n\nPatients recommended for resection who provide written informed consent will be randomised to one of the following treatment arms on the day of surgery by the surgeon:\n\nArm A: Blumgart method of panreaticojejunostomy. Arm B: CattellWarren method pf pancreaticojejunostomy.\n\nRandomisation will be undertaken intra-operatively, following pancreatic head excision, just prior to pancreatic head remnant reconstruction.\n\nPatients will be assessed post operatively on days 3 to 7 and on day of dishcharge from hospital. Patients will continue to be followed up in the outpatient setting at 3, 6 and 12 months post surgery.\n\nAll laboratory and physical assessments performed will be in line standard care.\n\nBlood samples for the translational study will be taken subject to informed consent pre-operatively and post-operatively 5 days after surgery.\n\nA histological (H\\&E stained) slide of the pancreatic transection margin should be taken as routine. This will be requested from each patient for central pathology review to assess the amount of fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an elective pancreato-duodenectomy for presumed malignancy.\n* Ability of the subject to understand the nature and consequences of the trial.\n* Ability to rovide writen informed consent.\n* Age 18 or greater.\n\nExclusion Criteria:\n\n* Patients undergoing extended pancreato-duodenectomy\n* Left, central or total pancreatectomy.\n* Arterial resection or multi-visceral resection\n* Previous pancreatic surgery\n* Surgery for known chronic pancreatitis.\n* Recruited to any other pancreatic resection trial.\n* Pregnant women.\n* Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from time of consent up to the day of surgery.'}, 'identificationModule': {'nctId': 'NCT02457156', 'acronym': 'PANasta', 'briefTitle': 'Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'PANasta Trial Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy - a Double Blinded Multi Centred Trial', 'orgStudyIdInfo': {'id': 'UoL000732'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blumgart Anastomosis', 'description': 'Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy.\n\nOctreotide will be administered.', 'interventionNames': ['Procedure: Blumgart Anastomosis', 'Drug: Octreotide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cattell-Warren Anastomosis', 'description': 'Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy.\n\nOctreotide will be administered.', 'interventionNames': ['Procedure: Cattell-Warren Anastomosis', 'Drug: Octreotide']}], 'interventions': [{'name': 'Blumgart Anastomosis', 'type': 'PROCEDURE', 'otherNames': ['Pancreatico-jejunostomy'], 'description': '1. Trans pancreatic suture "U" stich incorporating pancreatic parenchyma and jejunal serosa, left loose.\n2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.\n3. Trans pancreatic suture "U" stich brought back through the jejuanl serosa anteriorly, tied.', 'armGroupLabels': ['Blumgart Anastomosis']}, {'name': 'Cattell-Warren Anastomosis', 'type': 'PROCEDURE', 'otherNames': ['Pancreatico-jejunostomy'], 'description': '1. Posterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.\n2. Pancreatic duct to jejunal mucosa sutures, inserted and tied.\n3. Anterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.', 'armGroupLabels': ['Cattell-Warren Anastomosis']}, {'name': 'Octreotide', 'type': 'DRUG', 'otherNames': ['Sandostatin'], 'description': 'Octrotide (100ug) to be administered on the evening before surgery and then 100ug three times daily on the day of surgery and post operative days 1 - 6.', 'armGroupLabels': ['Blumgart Anastomosis', 'Cattell-Warren Anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Christopher Halloran', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liverpool'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}