Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors

Sponsor
Vo Truong Quoc (Other)
Overall Status
Recruiting
CT.gov ID
NCT05017207
Collaborator
(none)
145
1
19.9
7.3

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pancreaticoduodenectomy

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
145 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patient with periampullary cancer and pancreaticoduodenectomy

Only one group of patient with periampullary cancer

Procedure: Pancreaticoduodenectomy
Pancreaticoduodenectomy with one of 3 type of pancreatic-duodenal reconstructions

Outcome Measures

Primary Outcome Measures

  1. Pancreatic fistula [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 [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 Outcome Measures

  1. Short-term result in treatment of post-operative pancreatic fistula [30 days of post-operatvive period]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center of HCMC Ho Chi Minh City Vietnam 700000

Sponsors and Collaborators

  • Vo Truong Quoc

Investigators

  • Principal Investigator: Truong Quoc Vo, University of Medicine and Pharmacy at HoChiMinh City

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Vo Truong Quoc, Doctor, Lecturer, Surgeon, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier:
NCT05017207
Other Study ID Numbers:
  • Trquoc
First Posted:
Aug 23, 2021
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vo Truong Quoc, Doctor, Lecturer, Surgeon, University of Medicine and Pharmacy at Ho Chi Minh City
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022