Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-01 @ 1:23 PM
Study NCT ID:
NCT05657366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-21
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010185', 'term': 'Pancreatic Fistula'}, {'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010533', 'term': 'Peritoneal Lavage'}], 'ancestors': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-12-18', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Pancreatic Fistula (POPF)', 'timeFrame': '30 days post-operative', 'description': 'Presence of Amylase \\> 3 times the upper limit of normal in surgical drains'}], 'secondaryOutcomes': [{'measure': 'Biliary fistula', 'timeFrame': '90 days post-operative', 'description': 'Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out'}, {'measure': 'Post-Pancreatectomy Hemorrhage', 'timeFrame': '90 days post-operative', 'description': 'As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates'}, {'measure': 'Mortality', 'timeFrame': '90 days post-operative', 'description': 'Death related to surgical morbidity'}, {'measure': 'Delayed Gastric Emptying', 'timeFrame': '90 days post-operative', 'description': 'As defined by ISGPS, grade A, B and C rates'}, {'measure': 'Abdominal abscess or infection', 'timeFrame': '90 days post-operative', 'description': 'Collection \\>5cm in size, containing gas bubbles, determining systemic signs of infection'}, {'measure': 'Gastrojejunal/Duodenojejunal fistula', 'timeFrame': '90 days post-operative', 'description': 'Fistula from gastro/duodenojejunostomy'}, {'measure': 'Wound infection', 'timeFrame': '90 days post-operative', 'description': 'Superficial and Deep Surgical Site Incisional Infection'}, {'measure': 'Length of Hospital Stay', 'timeFrame': '1 year post-operative', 'description': 'calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission'}, {'measure': 'Reoperation', 'timeFrame': '90 days post-operative', 'description': 'Need for new surgery due to severe morbidity'}, {'measure': 'Readmission', 'timeFrame': '30 days post-operative', 'description': 'New admission within 30-days of discharge from hospital'}, {'measure': 'drainage tube duration', 'timeFrame': '90 days post-operative', 'description': 'Retention time of abdominal drainage tube'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Fistula', 'Pancreaticoduodenal; Fistula']}, 'descriptionModule': {'briefSummary': "As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.\n\nIn this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;\n2. Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;\n3. Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.\n\nExclusion Criteria:\n\n1. Complicated with severe liver, kidney, heart, brain, lung and other organ complications;\n2. Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;\n3. Patients and their families do not understand the treatment implementation plan of this study;\n4. Failure to complete follow-up;'}, 'identificationModule': {'nctId': 'NCT05657366', 'briefTitle': 'Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores', 'orgStudyIdInfo': {'id': 'zyeyPDlavage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low and medium risk（a-FRS）lavage', 'description': 'alternative pancreatic fistula risk score system，a-FRS Low risk group (0\\~5%), medium risk group (\\>5%\\~20%), lavage', 'interventionNames': ['Procedure: Peritoneal lavage']}, {'type': 'NO_INTERVENTION', 'label': 'low and medium risk（a-FRS） no lavage', 'description': 'alternative pancreatic fistula risk score system，a-FRS Low risk group (0\\~5%), medium risk group (\\>5%\\~20%), no lavage'}, {'type': 'EXPERIMENTAL', 'label': 'high risk（a-FRS）lavage', 'description': 'alternative pancreatic fistula risk score system，a-FRS high risk group (\\>20%) lavage', 'interventionNames': ['Procedure: Peritoneal lavage']}, {'type': 'NO_INTERVENTION', 'label': 'high risk（a-FRS）no lavage', 'description': 'alternative pancreatic fistula risk score system，a-FRS high risk group (\\>20%) no lavage'}], 'interventions': [{'name': 'Peritoneal lavage', 'type': 'PROCEDURE', 'description': 'Continuous abdominal flushing with normal saline', 'armGroupLabels': ['high risk（a-FRS）lavage', 'low and medium risk（a-FRS）lavage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The second affiliated hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Huanbing Zhu, PhD', 'role': 'CONTACT', 'email': 'juvanbn@zju.edu.cn', 'phone': '15857174159'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}