Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy
- Conditions
- Pancreatic Fistula
- Interventions
- Procedure: Pancreaticoduodenectomy
- Registration Number
- NCT05017207
- Lead Sponsor
- Vo Truong Quoc
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
- Patient with periampullary cancer and can be performed pancreaticoduodenectomy.
- Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.
- The patient does not consent to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with periampullary cancer and pancreaticoduodenectomy Pancreaticoduodenectomy Only one group of patient with periampullary cancer
- Primary Outcome Measures
Name Time Method 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)
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)
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University Medical Center of HCMC
🇻🇳Ho Chi Minh City, Vietnam