Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT01023594
Status:
UNKNOWN
Last Update Posted:
2015-09-15
First Post:
2009-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Feasibility Between Internal and External Pancreatic Drainage in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 328}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evidence of pancreatic fistula confirmed by serum and drain amylase', 'timeFrame': 'within the first 7 days after surgery'}], 'secondaryOutcomes': [{'measure': 'pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry', 'timeFrame': 'within the first 1 year after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic fistula', 'Pancreatic leakage', 'Pancreatoduodenectomy', 'Pancreatic stent'], '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': '9389397', 'type': 'BACKGROUND', 'citation': 'Lowy AM, Lee JE, Pisters PW, Davidson BS, Fenoglio CJ, Stanford P, Jinnah R, Evans DB. Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease. Ann Surg. 1997 Nov;226(5):632-41. doi: 10.1097/00000658-199711000-00008.'}, {'pmid': '18535760', 'type': 'BACKGROUND', 'citation': 'Butturini G, Daskalaki D, Molinari E, Scopelliti F, Casarotto A, Bassi C. Pancreatic fistula: definition and current problems. J Hepatobiliary Pancreat Surg. 2008;15(3):247-51. doi: 10.1007/s00534-007-1301-y. Epub 2008 Jun 6.'}, {'pmid': '17717446', 'type': 'BACKGROUND', 'citation': 'Poon RT, Fan ST, Lo CM, Ng KK, Yuen WK, Yeung C, Wong J. External drainage of pancreatic duct with a stent to reduce leakage rate of pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized trial. Ann Surg. 2007 Sep;246(3):425-33; discussion 433-5. doi: 10.1097/SLA.0b013e3181492c28.'}, {'pmid': '9923798', 'type': 'BACKGROUND', 'citation': 'Roder JD, Stein HJ, Bottcher KA, Busch R, Heidecke CD, Siewert JR. Stented versus nonstented pancreaticojejunostomy after pancreatoduodenectomy: a prospective study. Ann Surg. 1999 Jan;229(1):41-8. doi: 10.1097/00000658-199901000-00005.'}, {'pmid': '18516532', 'type': 'BACKGROUND', 'citation': 'Kamoda Y, Fujino Y, Matsumoto I, Shinzeki M, Sakai T, Kuroda Y. Usefulness of performing a pancreaticojejunostomy with an internal stent after a pancreatoduodenectomy. Surg Today. 2008;38(6):524-8. doi: 10.1007/s00595-007-3662-x. Epub 2008 May 31.'}, {'pmid': '12413321', 'type': 'BACKGROUND', 'citation': 'Ohwada S, Tanahashi Y, Ogawa T, Kawate S, Hamada K, Tago KI, Yamada T, Morishita Y. In situ vs ex situ pancreatic duct stents of duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy with billroth I-type reconstruction. Arch Surg. 2002 Nov;137(11):1289-93. doi: 10.1001/archsurg.137.11.1289.'}, {'pmid': '16708294', 'type': 'BACKGROUND', 'citation': 'Imaizumi T, Hatori T, Tobita K, Fukuda A, Takasaki K, Makuuchi H. Pancreaticojejunostomy using duct-to-mucosa anastomosis without a stenting tube. J Hepatobiliary Pancreat Surg. 2006;13(3):194-201. doi: 10.1007/s00534-005-1037-5.'}, {'pmid': '9230663', 'type': 'BACKGROUND', 'citation': 'Kim SW, Youk EG, Park YH. Comparison of pancreatogastrostomy and pancreatojejunostomy after pancreatoduodenectomy performed by one surgeon. World J Surg. 1997 Jul-Aug;21(6):640-3. doi: 10.1007/s002689900286.'}, {'pmid': '17114014', 'type': 'BACKGROUND', 'citation': 'Winter JM, Cameron JL, Campbell KA, Chang DC, Riall TS, Schulick RD, Choti MA, Coleman J, Hodgin MB, Sauter PK, Sonnenday CJ, Wolfgang CL, Marohn MR, Yeo CJ. Does pancreatic duct stenting decrease the rate of pancreatic fistula following pancreaticoduodenectomy? Results of a prospective randomized trial. J Gastrointest Surg. 2006 Nov;10(9):1280-90; discussion 1290. doi: 10.1016/j.gassur.2006.07.020.'}, {'pmid': '27040594', 'type': 'DERIVED', 'citation': 'Jang JY, Chang YR, Kim SW, Choi SH, Park SJ, Lee SE, Lim CS, Kang MJ, Lee H, Heo JS. Randomized multicentre trial comparing external and internal pancreatic stenting during pancreaticoduodenectomy. Br J Surg. 2016 May;103(6):668-675. doi: 10.1002/bjs.10160. Epub 2016 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. There are two distinct methods of pancreatic stent insertion: internal stent and external stent. There was few studies comparing these methods in preventing pancreatic fistula. Furthermore, its long-term effect was not known enough. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who have malignant or benign disease which needs pancreatoduodenectomy\n* patient age: ≥20 and ≤85\n\nExclusion Criteria:\n\n* patient who had chemotherapy or radiotherapy previous to operation.\n* patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular)\n* patient who had past medical history of chronic pancreatitis.\n* pancreatic stent size \\<1mm or \\>5mm'}, 'identificationModule': {'nctId': 'NCT01023594', 'briefTitle': 'Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'H-0908-040-290'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'External stent', 'description': 'Feeding tube insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.', 'interventionNames': ['Procedure: Pancreatic stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internal stent', 'description': 'short(5cm)internal stent insertion at pancreatojejunostomy site', 'interventionNames': ['Procedure: Pancreatic stent']}], 'interventions': [{'name': 'Pancreatic stent', 'type': 'PROCEDURE', 'description': 'Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.', 'armGroupLabels': ['External stent', 'Internal stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Center for Liver Cancer, National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Department of Surgery, Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '152-703', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Seoul National University Boramae Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Chung-ang University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sun-Whe Kim, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sun-Whe Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}