Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-03 @ 8:41 AM
Study NCT ID:
NCT02790333
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010185', 'term': 'Pancreatic 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification', 'timeFrame': 'Thirty days after operation', 'description': 'Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase \\> 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later'}, {'measure': 'Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'Thirty days after operation'}, {'measure': 'Mortality', 'timeFrame': 'Thirty days after operation'}, {'measure': 'Time to oral intake', 'timeFrame': 'Duration of hospital stay'}, {'measure': 'Postoperative hospital stay', 'timeFrame': 'Duration of hospital stay'}, {'measure': 'Readmission rate', 'timeFrame': 'Thirty days after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms', 'Pancreatic Fistula']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.', 'detailedDescription': "Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. disease of pancreatic body and tail\n2. Age: 18 years or older\n3. distant metastases are not diagnosed preoperatively.\n4. Patients who can provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with severe organ disease such as cardiac disease,respiratory illness\n2. Patients with pancreaticojejunostomy,pancreatogastrostomy\n3. Patients with conversion to laparotomy\n4. Patients with pregnancy'}, 'identificationModule': {'nctId': 'NCT02790333', 'briefTitle': 'Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula', 'organization': {'class': 'OTHER', 'fullName': "Zhejiang Provincial People's Hospital"}, 'officialTitle': 'A Randomized Trail Of Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula After Laparoscopic Distal Pancreatectomy', 'orgStudyIdInfo': {'id': 'ZJPPH-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tri-Staple reloads', 'description': 'Tri-Staple reloads were used for pancreatic stump texture', 'interventionNames': ['Procedure: Tri-Staple reloads']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional reloads', 'description': 'the traditional reloads were used for pancreatic stump texture', 'interventionNames': ['Procedure: traditional reloads']}], 'interventions': [{'name': 'traditional reloads', 'type': 'PROCEDURE', 'description': 'Blue cartridge with3.0mm height staple was used for pancreatic stump', 'armGroupLabels': ['traditional reloads']}, {'name': 'Tri-Staple reloads', 'type': 'PROCEDURE', 'description': 'Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump', 'armGroupLabels': ['Tri-Staple reloads']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Zhejiang Provincial Peoples' Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'YiPing Mou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi-Ping Mou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD，Director', 'investigatorFullName': 'Yi-Ping Mou', 'investigatorAffiliation': "Zhejiang Provincial People's Hospital"}}}}