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Completed

NCT Number: NCT04985071

Complication of Pancreatic Fistula and Bleeding After Pancreaticoduodenectomy in Treatment Periampullary Cancer

This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Phan Minh Tri

Ho Chi Minh City, 700000, Vietnam

About this study

The investigator will conduct this study at both site at the same time: Cho Ray Hospital and University and Pharmacy Center. The investigator will directly consult the patient to participate in the study, collect the preoperative information, intraoperative protocol and postoperative data. The investigator will statically analysis the incident of the morbidity (mainly for pancreatic fistula and bleeding), and invest some risk factors relating to those complications.

Plan for conducting the study:

  • The patient diagnosed with periampullary cancer will be consulted with surgical method, operative risks, postoperative complications and agree to participate in the study. The patient signes a consent form to participate in the study.
  • Pancreaticoduodenectomy will be performed according to the uniformity protocol of both hospitals: Cho Ray Hospital and University of Medicine and Pharmacy Center.
  • Post-operative data will be collected and based on the general procedure.

Data analysis

  • To determine the incidence of pancreatic fistula and bleeding, survival analysis will be used.
  • To determine the association of risk factors with pancreatic fistula and bleeding, logistic regression was used, the value with p < 0.05 will be included in the multivariable regression model to determine the real risk factors.

Sample size:

  • The investigator expect approximately 100 patients in the first year in both centers. And the investigator hope at least 110 patients in the whole conducting time.

Plan for missing data:

  • The investigator will directly collect the patient information before the operation, observe the operation process and follow-up the postoperative during. Investigator will remove any case that missing preoperative information, operative data or post-operative laboratory test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients diagnosed with periampullary cancer meet the following criteria:
  • Possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration.
  • The postoperative pathology is adenocarcinoma (of the ampulla of Vater, common bile duct, duodenum or pancreas)

Exclusion criteria

  • The patient has other organ's cancer beyond periampullary cancer.
  • Patient's medical conditions contraindicate for anesthesia.
  • The patient does not consent to participate in the study

Treatment and study plan

Pancreaticoduodenectomy

Procedure

Patient with periampullary cancer will be underwent pancreaticoduodenectomy in 2 types of pancreatic-jejunal anastomosis reconstructions. We describe the postoperative complications (pancreatic fistula and bleeding) and analysis the risk factors relate to those complications

Other names: Medical treatment after operation

Primary outcomes

  1. Pancreatic fistula

    Time frame: 90 post-operative days

    Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula

Secondary outcomes

  1. Bleeding complication

    Time frame: 90 post-operative days

    Rate and location of post-operative bleeding, risk factors relate to this complication

Sponsors and collaborators

Lead sponsor

Vo Truong Quoc

Other

Registry information

Official study title

Study of Pancreatic Fistula and Bleeding Complication After Pancreaticoduodenectomy in Treatment Periampullary Cancer

Acronym: PF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2021
Registry last updated
May 13, 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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