Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01324856
Status:
UNKNOWN
Last Update Posted:
2011-04-11
First Post:
2011-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-08', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-28', 'lastUpdatePostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'abdominal complications', 'timeFrame': '2 years', 'description': 'Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'periampulary cancer', 'pancreaticogastro vs pancreaticojejuno anastomosis'], 'conditions': ['Pancreatic Cancer', 'Pancreatic Anastomotic Leak']}, 'referencesModule': {'references': [{'pmid': '17236843', 'type': 'BACKGROUND', 'citation': 'Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Buchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. doi: 10.1016/j.amjsurg.2006.10.010.'}, {'pmid': '16327486', 'type': 'BACKGROUND', 'citation': 'Bassi C, Falconi M, Molinari E, Salvia R, Butturini G, Sartori N, Mantovani W, Pederzoli P. Reconstruction by pancreaticojejunostomy versus pancreaticogastrostomy following pancreatectomy: results of a comparative study. Ann Surg. 2005 Dec;242(6):767-71, discussion 771-3. doi: 10.1097/01.sla.0000189124.47589.6d.'}, {'pmid': '7574936', 'type': 'BACKGROUND', 'citation': 'Yeo CJ, Cameron JL, Maher MM, Sauter PK, Zahurak ML, Talamini MA, Lillemoe KD, Pitt HA. A prospective randomized trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy. Ann Surg. 1995 Oct;222(4):580-8; discussion 588-92. doi: 10.1097/00000658-199510000-00014.'}]}, 'descriptionModule': {'briefSummary': 'Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign disease of the pancreas and periampullariy region. During the recent years, mortality rate of pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure still carries considerable morbidity up to 40%, depending of definition of complications. Pancreatic fistula remains a common complication and the main cause of other morbidities and mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of reconstruction after pancreaticoduodenectomy. Several technique modifications such as placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease pancreatic fistula rate. Since, some retrospective studies showed better results with some technique, several meta-analyses did not show any advantage of those various modifications. It was shown that the higher risk of pancreatic fistula was noticed in patients with soft residual pancreas and small diameter of pancreatic duct. There is only one randomized study in the literature dealing with this problem. This study did not reveal any significant differences between PG and PJ in patients with soft pancreas and small duct. In order to investigate once more this important issue, the researchers conducted randomized multicenter controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergone cephalic duodenopanceatectomy\n* soft pancreas\n* small diameter of the pancreatic remnant\n\nExclusion Criteria:\n\n* Age bellow 18 and under 80\n* prevous pancreatic surgery\n* pregnancy\n* Psychosis'}, 'identificationModule': {'nctId': 'NCT01324856', 'acronym': 'PanAm', 'briefTitle': 'Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Results of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy in Patients With Soft Pancreas and Small Pancreatic Duct', 'orgStudyIdInfo': {'id': 'D672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pancreaticogastro anastomosis', 'interventionNames': ['Procedure: Pancreatico gastro anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pancreaticojejuno anastomosis', 'interventionNames': ['Procedure: Pancreaticojejuno anastomosis']}], 'interventions': [{'name': 'Pancreatico gastro anastomosis', 'type': 'PROCEDURE', 'description': 'After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico gasto teremino-lateral anastomosis will be performed. The anastomosis will be done with posterior wall of the stomach. Pancreas will be mobilized at least 5 cm, two tobaco stiches will be applied on posterior wall of the stomach and hole of 2 cm will be done in the middle. Anterior wall of the stomach will be opened, for easier placement of the pancreas in to the stomach cavity. Pancreas will be entered in the stomach trough , tobacco stitches tided and just 2 or 3 stitches will be applied on the stomach mucosa and pancreatic capsule. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.', 'armGroupLabels': ['Pancreaticogastro anastomosis']}, {'name': 'Pancreaticojejuno anastomosis', 'type': 'PROCEDURE', 'description': 'After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico jejuno termino lateral duct to mucosa anastomosis will be performed. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.', 'armGroupLabels': ['Pancreaticojejuno anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'contacts': [{'name': 'Dejan Radenkovic, MD, PhD', 'role': 'CONTACT', 'email': 'dejanr@sbb.rs', 'phone': '+381 63 204 205'}, {'name': 'Dejan Radenkovic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Surgical Department, Military-Medical Academy', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'centralContacts': [{'name': 'Dejan Radenkovic, MD, PhD', 'role': 'CONTACT', 'email': 'dejanr@sbb.rs', 'phone': '+381 63 204 205'}], 'overallOfficials': [{'name': 'Dejan Radenkovic, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Digestive disease, Clinical center of Serbia and School of Medicine University of Belgrade'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dejan Radenkovic', 'oldOrganization': 'Clinic for Digestive surgery, Clinical Center of Serbia'}}}}