Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Not Applicable

• Conditions: Pancreatic Fistula
• Interventions: Procedure: Pancreatic stent

• Registration Number: NCT01023594
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Study Start: 2010-01
• Primary Completion: 2014-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External stent	Pancreatic stent	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.
Internal stent	Pancreatic stent	short(5cm)internal stent insertion at pancreatojejunostomy site

Primary Outcome Measures

Name	Time	Method
evidence of pancreatic fistula confirmed by serum and drain amylase	within the first 7 days after surgery

Secondary Outcome Measures

Name	Time	Method
pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry	within the first 1 year after surgery

Trial Locations

Locations (8)

Center for Liver Cancer, National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Department of Surgery, Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Department of Surgery, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Department of Surgery, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Department of Surgery, Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Department of Surgery, Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of

Department of Surgery, Chung-ang University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Department of Surgery, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of