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Spots Global Cancer Trial Database for Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

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Trial Identification

Brief Title: Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

Official Title: Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study

Study ID: NCT05017207

Study Description

Brief Summary: Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors

Detailed Description: This study will conduct at two centers at the same time: University of Medicine and Pharmacy Center and Cho Ray Hospital. The patients will be consulted to participate to this research from September, 2021 to April, 2023. Plan for conducting study: * The investigator consults and gets consensus form of the patient with periampullary cancer. * The patient will be prepared for pancreaticoduodenectomy: pre-operative laboratory test, pre-operative biliary drainage, anesthetic checking. * The investigator collected intr-operative data, include type of pancreatic-duodenal reconstruction, type of pancreatic duct's drainage, quantity of blood loss and blood transfusion. * The investor follows post-operative period. * If there are pancreatic fistula appear, the investigator will collect the clinical signs, laboratory test changing, re-operative morphology. * The investigator analysis the risk factors of pancreatic fistula. Data analysis: * To determine the incidence of pancreatic fistula, the morphology of pancreatic fistula, descriptive statistics will be used. * To determine the risk factors of pancreatic fistula, logistic regression will be used. Sample size: * The investigator plans to collect 145 patients in the research period. Plan for missing data: * Any case that miss information will be removed from the study.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Medical Center of HCMC, Ho Chi Minh City, , Vietnam

Contact Details

Name: Truong Quoc Vo

Affiliation: University of Medicine and Pharmacy at HoChiMinh City

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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