Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT05789459
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2023-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013528', 'term': 'Surgical Staplers'}, {'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D013525', 'term': 'Surgical Instruments'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pancreatic fistula (POPF)', 'timeFrame': 'Within 3 months after pancreatic surgery', 'description': 'The outcome was POPF per the International Study Group of Pancreatic Surgery definition'}], 'secondaryOutcomes': [{'measure': 'delayed gastric emptying (DGE)', 'timeFrame': 'Within 3 months after pancreatic surgery', 'description': 'identified and graded according to the ISGPS criteria'}, {'measure': 'postpancreatectomy hemorrhage (PPH)', 'timeFrame': 'Within 3 months after pancreatic surgery', 'description': 'identified and graded according to the ISGPS criteria'}, {'measure': 'Chyle leak', 'timeFrame': 'Within 3 months after pancreatic surgery', 'description': 'identified and graded according to the ISGPS criteria'}, {'measure': 'Surgical complications', 'timeFrame': 'Within 3 months after pancreatic surgery', 'description': 'classified according to the Clavien-Dindo system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Pancreatectomy', 'Postoperative Pancreatic Fistula']}, 'descriptionModule': {'briefSummary': 'The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental.\n\nResearchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP.\n\nTherefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent MDP in our institution between July 2018 and June 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy\n\nExclusion Criteria:\n\n* Incomplete medical records\n* History of previous pancreatic operations\n* Emergent operation\n* Conversion to open pancreatectomy\n* Receipt of wedge resection or other procedures'}, 'identificationModule': {'nctId': 'NCT05789459', 'briefTitle': 'Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Comparison of Outcomes With Stapler Versus Hand-Sewn Closure of the Pancreatic Stump Following Minimally Invasive Distal Pancreatectomy: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'DP-POPF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stapler group', 'description': 'closure with a stapler', 'interventionNames': ['Device: Stapler']}, {'label': 'Hand-sewn group', 'description': 'closure with suture', 'interventionNames': ['Other: Suture']}], 'interventions': [{'name': 'Stapler', 'type': 'DEVICE', 'description': 'Stapler', 'armGroupLabels': ['Stapler group']}, {'name': 'Suture', 'type': 'OTHER', 'description': 'Suture', 'armGroupLabels': ['Hand-sewn group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'the First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Tingbo Liang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'TingBo Liang', 'investigatorAffiliation': 'Zhejiang University'}}}}