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2021-08-01
2023-10-31
2023-10-31
183
NCT04985071
University of Medicine and Pharmacy at Ho Chi Minh City
University of Medicine and Pharmacy at Ho Chi Minh City
OBSERVATIONAL
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-07-26 | N/A | 2024-05-10 |
2021-07-26 | N/A | 2024-05-13 |
2021-08-02 | N/A | 2024-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pancreatic fistula | Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula | 90 post-operative days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Bleeding complication | Rate and location of post-operative bleeding, risk factors relate to this complication | 90 post-operative days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
