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

February 28, 2023 updated by: Vo Truong Quoc

Study of Pancreatic Fistula and Bleeding Complication 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with periampullary cancer will be underwent pancreaticoduodenectomy and will be followed-up after operation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic fistula
Time Frame: 90 post-operative days
Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula
90 post-operative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding complication
Time Frame: 90 post-operative days
Rate and location of post-operative bleeding, risk factors relate to this complication
90 post-operative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vo Truong Quoc

Investigators

  • Principal Investigator: TruongQuoc Vo, Doctor, University of Medicine and Pharmacy at HoChiMinh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTrQuoc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will be saved as a excel and spss file (with a password to open). This data can be shared with other researchers if needed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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