Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT04798560
Status:
UNKNOWN
Last Update Posted:
2021-03-15
First Post:
2021-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010185', 'term': 'Pancreatic Fistula'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016577', 'term': 'Pancreaticoduodenectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Postoperative pancreatic fistula after pancreaticoduodenectomy', 'timeFrame': '30 days', 'description': 'Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Mortality rates expressed in % of the patients'}, {'measure': 'Morbidity', 'timeFrame': '30 days', 'description': 'Morbidity rates expressed in % of the patients'}, {'measure': 'Postoperative complications', 'timeFrame': '30 days', 'description': 'Complications classified according to Clavien-Dindo Classification taking measures from I up to V'}, {'measure': 'Duration of Hospital stay', 'timeFrame': '60 days', 'description': 'Duration of Hospital stay in days'}, {'measure': 'Readmission', 'timeFrame': '30 days', 'description': 'Readmission rates expressed in % of the patients'}, {'measure': 'Reoperation', 'timeFrame': '30 days', 'description': 'Reoperation rates expressed in % of the patients'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Estimation of days from operation until death expressed in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreaticoduodenectomy', 'pancreatic cancer', 'pancreatic adenocarcinoma'], 'conditions': ['Pancreatic Fistula', 'Whipple Operation', 'Pancreaticoduodenectomy', 'POPF']}, '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': '28040257', 'type': 'BACKGROUND', 'citation': 'Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.'}, {'pmid': '7524375', 'type': 'BACKGROUND', 'citation': 'Cullen JJ, Sarr MG, Ilstrup DM. Pancreatic anastomotic leak after pancreaticoduodenectomy: incidence, significance, and management. Am J Surg. 1994 Oct;168(4):295-8. doi: 10.1016/s0002-9610(05)80151-5.'}, {'pmid': '22882195', 'type': 'BACKGROUND', 'citation': 'Denbo JW, Orr WS, Zarzaur BL, Behrman SW. Toward defining grade C pancreatic fistula following pancreaticoduodenectomy: incidence, risk factors, management and outcome. HPB (Oxford). 2012 Sep;14(9):589-93. doi: 10.1111/j.1477-2574.2012.00486.x. Epub 2012 May 28.'}, {'pmid': '29588609', 'type': 'BACKGROUND', 'citation': 'Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018.'}, {'pmid': '25207767', 'type': 'BACKGROUND', 'citation': 'Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Sep 11;371(11):1039-49. doi: 10.1056/NEJMra1404198. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques. Surgery is the only therapeutic option with an intend to treat. Pancreaticoduodenectomy is indicated for malignancy in the pancreatic head as well as other periampullary tumors. One of the most fatal complications after Whipple operation is postoperative pancreatic fistula as a result of pancreatojejunostomy leakage. Various risk factors for pancreatojejunostomy leakage have been proposed, while there are others less studied.', 'detailedDescription': 'This is a prospective observational study conducted in the 1st Propaedeutic Department of Surgery of the National and Kapodistrian University of Athens, Greece. Patients with imaging and/or histologically proven periampullary tumors in which Whipple operation is indicated will be enrolled in the study after signing a consent designed by the Hospitals Ethics Commitee and the Department of Surgery. Patients information and medical history will be recorded, giving emphasis on clinical presentation, signs and symptoms related to the patients disease. Laboratory tests will afterwards take place, including biochemical parameters such as total bilirubin levels, serum albumin, CA 19-9, CEA, HbA1c and ferritine levels prior to operation. During operation, as soon as the specimen has been removed, the horizontal and vertical dimension of the pancreatic cutting surface will be measured with the use of an one use sterile ruler and the area of the cutting surface will then be calculated as well as the ratio of the two dimensions (horizontal/vertical). The diameter of the pancreatic duct will be measured either with the same ruler in case diameter is equal or greater than 3mm or with a use of a plastic stent in case diameter is less than 3mm. Pancreatic texture will also be assesed. Other intraoperative datas will be recorded such as the anastomosis technique, duration of surgery, amount of fluid administration, transfusion with fresh frosen plasma or blood units.Postoperatively, amylase from the drains, white blood cell count, platelet count and serum crp levels will be recorded on the 1st, 3rd and 5th postoperative day in all patients. The definition used for postoperative pancreatic fistula (POPF) is based on the International Study Group of Pancreatic Fistula 2016 definition and patients will be categorised accordingly. There will be two arms of patients. The first arm will include patients with either no POPF or Biochemical Leak (BL) and the second arm patients with Grade B or C POPF.\n\nAny complication in the early postoperative period ,defined as the first 30 days after Whipple operation, will be recorded and categorised according to Clavien Dindo classification, including reoperation, readmissions or prolongation of hospital stay. After discharge, follow up of the patients include the EORTC QLQ-C30 and EORTC QLQ-PAN 26 questionnaires that patients have to fill in one, three, six and twelve months after surgery. Reccurence and survival rates will accordingly be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 18 years of age with imaging findings or histologically proven periampullary tumors requiring pancreaticoduodenectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age more than or equal to 18 years\n2. periampullary pathologies (benign or malignant) with indication for panceaticoduodenectomy\n3. Pancreaticojejunal anastomosis performed\n4. Curative resection\n5. Signed informed consent form -\n\nExclusion Criteria:\n\n1. Age less than 18 years old\n2. One stage total pancreatectomy\n3. External wirsungostomy without pancreaticojejunal anastomosis\n4. Subtotal pancreatectomy without pancreaticojejunal anastomosis\n5. Left pancreatectomies\n6. Intraoperatively findings of unresectable tumors\n7. Pregnancy\n8. Concurrent participation in other study(ies)'}, 'identificationModule': {'nctId': 'NCT04798560', 'briefTitle': 'Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Risk Factors for Pancreaticojejunostomy Leakage Following Whipple Operation', 'orgStudyIdInfo': {'id': '8515/31-05-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing Whipple operation', 'description': 'After Whipple operation patients will be observed for complications and emphasis will be given on the presence of postoperative pancreatic fistula (POPF) according to the ISGPF 2016 definition. There will be to arms of patients. The first will include patients that do not develop POPF or either develop Biochemical Leak (Grade A). The second group consist of patients that develop either Grade B or Grade C POPF', 'interventionNames': ['Procedure: Pancreaticoduodenectomy']}], 'interventions': [{'name': 'Pancreaticoduodenectomy', 'type': 'PROCEDURE', 'description': 'Patients udergo pancreaticoduodenectomy for periampullary tumors. All of them are observed for developing POPF', 'armGroupLabels': ['Patients undergoing Whipple operation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'facility': '1st Propaedeutic Department of Surgery, Hippokrateion General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Dimitrios Vouros, MD, MSc', 'role': 'CONTACT', 'email': 'jimsamiotis@hotmail.com', 'phone': '+30 2132088142'}, {'name': 'Konstantinos Toutouzas, Profesor', 'role': 'CONTACT', 'email': 'tousur@hotmail.com', 'phone': '+30 6970801370'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dimitrios Vouros', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dimitrios Vouros', 'investigatorAffiliation': 'University of Athens'}}}}