Pancreatic Fistula
Conditions
Keywords
Risk factor
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.
Interventions
PROCEDUREPancreaticoduodenectomy
Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa
Sponsors
Vo Truong Quoc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Vietnam
Outcome results
None listed