Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-07 @ 6:03 AM
Study NCT ID:
NCT01696903
Status:
COMPLETED
Last Update Posted:
2017-12-20
First Post:
2012-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010185', 'term': 'Pancreatic Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010193', 'term': 'Pancreaticojejunostomy'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2012-09-25', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Severity of postoperative complications', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.'}], 'primaryOutcomes': [{'measure': 'Clinically Relevant Postoperative Pancreatic Fistula', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula'}], 'secondaryOutcomes': [{'measure': 'Associated postoperative morbidity', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postoperative pancreatic fistula', 'Pancreatic texture', 'Pancreatic duct diameter', 'Pancreatic consistency', 'Pancreaticoduodenectomy'], 'conditions': ['Pancreatic Fistula']}, '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': '22556164', 'type': 'BACKGROUND', 'citation': 'Ansorge C, Strommer L, Andren-Sandberg A, Lundell L, Herrington MK, Segersvard R. Structured intraoperative assessment of pancreatic gland characteristics in predicting complications after pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1076-82. doi: 10.1002/bjs.8784. Epub 2012 May 4.'}, {'pmid': '21845376', 'type': 'BACKGROUND', 'citation': 'Kennedy EP, Yeo CJ. Dunking pancreaticojejunostomy versus duct-to-mucosa anastomosis. J Hepatobiliary Pancreat Sci. 2011 Nov;18(6):769-74. doi: 10.1007/s00534-011-0429-y.'}], 'seeAlsoLinks': [{'url': 'http://ki.se', 'label': 'Issuer organization'}, {'url': 'http://www.karolinska.se', 'label': 'Investigation site'}, {'url': 'http://www.lio.se', 'label': 'Investigation site'}]}, 'descriptionModule': {'briefSummary': 'Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.', 'detailedDescription': 'Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective pancreaticoduodenectomy\n* Pancreatic gland with high risk criteria for associated postoperative morbidity\n\nExclusion Criteria:\n\n* Patients do not accept participation\n* Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity'}, 'identificationModule': {'nctId': 'NCT01696903', 'briefTitle': 'Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula', 'orgStudyIdInfo': {'id': 'SKARV-GLH-001'}, 'secondaryIdInfos': [{'id': 'KI-DSGE-DUAS', 'type': 'OTHER', 'domain': 'Karolinska Institutet'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional anastomosis', 'description': 'Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell\'s duct-to-mucosa technique".'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Novel anastomosis', 'description': 'Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.', 'interventionNames': ['Procedure: Pancreaticojejunostomy technique']}], 'interventions': [{'name': 'Pancreaticojejunostomy technique', 'type': 'PROCEDURE', 'otherNames': ['Pancreaticojejunal anastomosis', 'Intubating pancreaticojejunostomy', 'Dunking pancreaticojejunostomy', 'pancreatojejunostomy'], 'description': 'The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.', 'armGroupLabels': ['Novel anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Department of Upper Abdominal Surgery, Linköping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Surgical gastroenterology, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Christoph Ansorge, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Ralf Segersvärd, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Christoph Ansorge, MD, PhD', 'investigatorFullName': 'Christoph Ansorge', 'investigatorAffiliation': 'Karolinska Institutet'}}}}