Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Study Overview
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Brief Summary
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Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. There are two distinct methods of pancreatic stent insertion: internal stent and external stent. There was few studies comparing these methods in preventing pancreatic fistula. Furthermore, its long-term effect was not known enough. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

Official Title
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Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Procedure: Pancreatic stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient who have malignant or benign disease which needs pancreatoduodenectomy patient age: ≥20 and ≤85 Exclusion Criteria: patient who had chemotherapy or radiotherapy previous to operation. patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular) patient who had past medical history of chronic pancreatitis. pancreatic stent size <1mm or >5mm

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: External stent<br>Feeding tube insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall. | Procedure: Pancreatic stent<br>* Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.<br>|
| Active Comparator: Internal stent<br>short(5cm)internal stent insertion at pancreatojejunostomy site | Procedure: Pancreatic stent<br>* Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of pancreatic fistula confirmed by serum and drain amylase |  | within the first 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry |  | within the first 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic fistula, Pancreatic leakage, Pancreatoduodenectomy, Pancreatic stent