Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01023594

Collaborator

(none)

328

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Fistula	Procedure: Pancreatic stent	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

328 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: External 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.	Procedure: 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: Internal stent short(5cm)internal stent insertion at pancreatojejunostomy site	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: External 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.

Procedure: 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: Internal stent

short(5cm)internal stent insertion at pancreatojejunostomy site

Procedure: Pancreatic stent

Outcome Measures

Primary Outcome Measures

evidence of pancreatic fistula confirmed by serum and drain amylase [within the first 7 days after surgery]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Liver Cancer, National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769
2	Department of Surgery, Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of	463-707
3	Department of Surgery, Seoul National University Hospital	Seoul		Korea, Republic of	110-744
4	Department of Surgery, Samsung Medical Center	Seoul		Korea, Republic of	135-710
5	Department of Surgery, Korea University Guro Hospital	Seoul		Korea, Republic of	152-703
6	Department of Surgery, Seoul National University Boramae Hospital	Seoul		Korea, Republic of	156-707
7	Department of Surgery, Chung-ang University College of Medicine	Seoul		Korea, Republic of
8	Department of Surgery, Gangnam Severance Hospital	Seoul		Korea, Republic of