Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-10-31

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

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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.

Conditions

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Pancreatic Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with periampullary cancer and pancreaticoduodenectomy

Only one group of patient with periampullary cancer

Pancreaticoduodenectomy

Intervention Type PROCEDURE

Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa

Interventions

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Pancreaticoduodenectomy

Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa

Intervention Type PROCEDURE

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.