Overview

This trial is active, not recruiting.

Condition pancreatic fistula
Treatment pancreatic stent
Sponsor Seoul National University Hospital
Start date January 2010
End date January 2014
Trial size 328 participants
Trial identifier NCT01023594, H-0908-040-290

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
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.
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.
(Active Comparator)
short(5cm)internal stent insertion at pancreatojejunostomy site
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.

Primary Outcomes

Measure
evidence of pancreatic fistula confirmed by serum and drain amylase
time frame: within the first 7 days after surgery

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 85 years old.

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

Additional Information

Official title Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.