Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

NCT05017207 | Completed

• 1 other identifier: Trquoc
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Fistula

Keywords

Risk factor

Outcome Measures

Primary Outcomes (2)

• Pancreatic fistula

  The investigator will describe the day that appears pancreatic fistula, the clinical symptoms, intra-operative morphology if being indicated to re-operate. The measurement tool to diagnose pancreatic fistula is fluid amylase on the POD3 (fluid amylse is 3 times compared to serum's amylase)

  30 days of post-operative period

• Risk factors relate to pancreatic fistula

  The investigator will analyse some of the risk factors that relate to pancreatic fistula, including pre-operative factors (BMI, albumin, bilirubin, biliary drainage), intra-operative elements (pancreatic duct 's diameter, pancreatic textile, blood transfusion, portal vein reconstruction), and post-operative factors (abdominal drainage's volume, fluid amylase, abdominal abscess..). The investigator will use the multivariable regression model to determine the risk factors (p-value\<0.05)

  30 days of post-operative period

Secondary Outcomes (1)

• Short-term result in treatment of post-operative pancreatic fistula

  30 days of post-operatvive period

Study Arms (1)

Patient with periampullary cancer and pancreaticoduodenectomy

Only one group of patient with periampullary cancer

Procedure: Pancreaticoduodenectomy

Interventions

Pancreaticoduodenectomy PROCEDURE

Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa

Patient with periampullary cancer and pancreaticoduodenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Periampullary cancer with postoperative pathology is adenocarcinoma

You may qualify if:

• Patient with periampullary cancer and can be performed pancreaticoduodenectomy.
• Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.

You may not qualify if:

• The patient does not consent to participate in the study

Sponsors & Collaborators

• Vo Truong Quoc: lead

Study Sites (1)

University Medical Center of HCMC

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (1)

• Kawaida H, Kono H, Hosomura N, Amemiya H, Itakura J, Fujii H, Ichikawa D. Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery. World J Gastroenterol. 2019 Jul 28;25(28):3722-3737. doi: 10.3748/wjg.v25.i28.3722.

  PMID: 31391768 BACKGROUND

Related Links

• Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Truong Quoc Vo

  University of Medicine and Pharmacy at HoChiMinh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, Lecturer, Surgeon

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 23, 2021
• Study Start: August 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)