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Completed

NCT Number: NCT05017207

Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center of HCMC

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The patient does not consent to participate in the study

Treatment and study plan

Pancreaticoduodenectomy

Procedure

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

Primary outcomes

  1. Pancreatic fistula

    Time frame: 30 days of post-operative period

    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)

  2. Risk factors relate to pancreatic fistula

    Time frame: 30 days of post-operative period

    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)

Secondary outcomes

  1. Short-term result in treatment of post-operative pancreatic fistula

    Time frame: 30 days of post-operatvive period

    The investigator will describe the result of pancreatic fistula treatment: intra-operative morphology, re-operative success ratio, morbidities.

Sponsors and collaborators

Lead sponsor

Vo Truong Quoc

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2021
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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