Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT01051856
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
2010-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
TissueLink Versus SEAMGUARD After Distal Pancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'que.florencia@mayo.edu', 'phone': '507-284-6178', 'title': 'Florencia G. Que, MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial closed early due to poor accrual of subjects.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected within the 90 day perioperative period.', 'eventGroups': [{'id': 'EG000', 'title': 'SEAMGUARD With Bioabsorbable Staple', 'description': 'SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.', 'otherNumAtRisk': 32, 'otherNumAffected': 15, 'seriousNumAtRisk': 32, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'TissueLink With Radiofrequency Ablation', 'description': 'TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.', 'otherNumAtRisk': 35, 'otherNumAffected': 23, 'seriousNumAtRisk': 35, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Pancreatic fistula drainage longer than 3 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drained Amylase 3 Times Normal Upper Limit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Specific Treatment for Pancreatic Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic Fistula Documented by X-Ray', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospital readmission for pancreatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Percutaneous Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm due to pancreatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intensive Care Unit or Progressive Care Unit Stay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SEAMGUARD With Bioabsorbable Staple', 'description': 'SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.'}, {'id': 'OG001', 'title': 'TissueLink With Radiofrequency Ablation', 'description': 'TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '90 days from the operation', 'description': 'Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Severity of the Pancreatic Fistula Leaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SEAMGUARD With Bioabsorbable Staple', 'description': 'SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.'}, {'id': 'OG001', 'title': 'TissueLink With Radiofrequency Ablation', 'description': 'TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.'}], 'classes': [{'title': 'Clinically significant pancreatic fistula leaks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Non-clinically significant pancreatic fistula leak', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days post operative', 'description': 'Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.', 'unitOfMeasure': 'Pancreatic fistula leaks', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SEAMGUARD With Bioabsorbable Staple', 'description': 'SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.'}, {'id': 'FG001', 'title': 'TissueLink With Radiofrequency Ablation', 'description': 'TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from January 2010 to March 2014 at Mayo Clinic in Rochester, Minnesota, and at Massachusetts General Hospital in Boston, Massachusetts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SEAMGUARD With Bioabsorbable Staple', 'description': 'SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.'}, {'id': 'BG001', 'title': 'TissueLink With Radiofrequency Ablation', 'description': 'TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.84', 'spread': '12.73', 'groupId': 'BG000'}, {'value': '56.29', 'spread': '12.79', 'groupId': 'BG001'}, {'value': '57.99', 'spread': '12.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.60', 'spread': '5.08', 'groupId': 'BG000'}, {'value': '28.56', 'spread': '5.25', 'groupId': 'BG001'}, {'value': '28.09', 'spread': '5.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '34 participants in the TissueLink arm were included in the BMI analysis; the data were not available on one participant.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'The trial closed early due to poor accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2010-01-15', 'resultsFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-29', 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation', 'timeFrame': '90 days from the operation', 'description': 'Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.'}], 'secondaryOutcomes': [{'measure': 'Severity of the Pancreatic Fistula Leaks', 'timeFrame': '90 days post operative', 'description': 'Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Distal Pancreatectomy']}, 'referencesModule': {'references': [{'pmid': '16003309', 'type': 'BACKGROUND', 'citation': 'Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.'}, {'pmid': '27916372', 'type': 'DERIVED', 'citation': 'Shubert CR, Ferrone CR, Fernandez-Del Castillo C, Kendrick ML, Farnell MB, Smoot RL, Truty MJ, Que FG. A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856. J Surg Res. 2016 Nov;206(1):32-40. doi: 10.1016/j.jss.2016.06.034. Epub 2016 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.', 'detailedDescription': "The objective of this trial is to compare the effectiveness of TissueLink closure of pancreatic stump after distal pancreatectomy to that of SEAMGUARD reinforced stapler closure.\n\nDistal pancreatectomy is performed for a broad variety of indications including benign and malignant conditions. Specifically, distal pancreatectomy refers to resection of the portion of pancreas to the left of the superior mesenteric vein/portal vein trunk, excluding the duodenum and distal bile duct. Pancreatic duct leak at the resection margin is one of the most common complications of distal pancreatectomy. This complication prolongs in-patient and outpatient care and resulting in significant detriments to the patient's operative experience and increases in the financial burden of pancreatic surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age equal or above 18 years\n2. Accepted for elective distal pancreatectomy for any indication\n\nExclusion from randomization process:\n\n* Thickness of pancreas on preoperative CT scan images \\> 2.5 cm at the site of expected transection in anterior-posterior diameter. This will be reviewed by the surgeon the day before the surgeon sees the patient to predetermine the appropriateness of the patient for the study.\n\nGeneral study exclusion criteria:\n\n1. Current immunosuppressive therapy\n2. Chemotherapy within 2 weeks before operation\n3. Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation\n4. Radiotherapy before operation\n5. Inability to follow the instructions given by the investigator\n6. Lack of compliance\n7. Persons unable or unwilling to give informed consent to participate in this study\n8. Pregnant women\n9. Prisoners\n10. Institutionalized individuals'}, 'identificationModule': {'nctId': 'NCT01051856', 'acronym': 'PLATS', 'briefTitle': 'TissueLink Versus SEAMGUARD After Distal Pancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SEAMGUARD After Distal Pancreatectomy (PLATS)', 'orgStudyIdInfo': {'id': '09-000362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SEAMGUARD with bioabsorbable staple', 'description': 'In this arm pancreatic transection will be executed using an endoscopic linear stapling device. The individual staple depth can be chosen by the operating surgeon. Bioabsorbable Mesh sleeves specifically manufactured for the chosen staple depth and cartridge length will be placed over the stapler before firing.', 'interventionNames': ['Device: SEAMGUARD with bioabsorbable staple']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TissueLink with radiofrequency ablation', 'description': 'After pancreatic transection, with any method chosen by the operating surgeon, the pancreatic remnant will be treated with TissueLink alone for an ablation depth (thickness) of approximately 7 mm using electrosurgical generator settings of 100 W and a saline drip rate of 1-2 drops per second.', 'interventionNames': ['Procedure: TissueLink with radiofrequency ablation']}], 'interventions': [{'name': 'SEAMGUARD with bioabsorbable staple', 'type': 'DEVICE', 'description': 'In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.', 'armGroupLabels': ['SEAMGUARD with bioabsorbable staple']}, {'name': 'TissueLink with radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.', 'armGroupLabels': ['TissueLink with radiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02144', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusettes General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Florencia G Que, M.D. S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic, Rochester, MN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}