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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Procedure: Pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with periampullary cancer and pancreaticoduodenectomy<br>Only one group of patient with periampullary cancer | Procedure: Pancreaticoduodenectomy<br>* Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistula | 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) | 30 days of post-operative period | 
| Risk factors relate to pancreatic fistula | 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) | 30 days of post-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term result in treatment of post-operative pancreatic fistula | The investigator will describe the result of pancreatic fistula treatment: intra-operative morphology, re-operative success ratio, morbidities. | 30 days of post-operatvive period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk factor