Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Seoul National University

Status: Unknown

Conditions: Pancreatic Fistula

Treatments: Procedure: Pancreatic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01023594

H-0908-040-290

Details and patient eligibility

About

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.

Enrollment: 328 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

External stent

Active Comparator group

Description:

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.

Treatment:

Procedure: Pancreatic stent

Internal stent

Active Comparator group

Description:

short(5cm)internal stent insertion at pancreatojejunostomy site

Treatment:

Procedure: Pancreatic stent