Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Seoul National University Hospital328 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

328

Conditions

Pancreatic Fistula

Interventions

Pancreatic stent

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (8)

Center for Liver Cancer, National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Department of Surgery, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Department of Surgery, Seoul National University Hospital

Seoul, Seoul, South Korea

Department of Surgery, Samsung Medical Center

Seoul, South Korea

Department of Surgery, Korea University Guro Hospital

Seoul, South Korea

Department of Surgery, Seoul National University Boramae Hospital

Seoul, South Korea

Department of Surgery, Chung-ang University College of Medicine

Seoul, South Korea

Department of Surgery, Gangnam Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

evidence of pancreatic fistula confirmed by serum and drain amylase

Time frame: within the first 7 days after surgery

Secondary Outcomes

pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry

Time frame: within the first 1 year after surgery