Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

September 14, 2015 updated by: Sun-Whe Kim, Seoul National University Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Department of Surgery, Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Department of Surgery, Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 135-710
        • Department of Surgery, Samsung Medical Center
      • Seoul, Korea, Republic of, 152-703
        • Department of Surgery, Korea University Guro Hospital
      • Seoul, Korea, Republic of, 156-707
        • Department of Surgery, Seoul National University Boramae Hospital
      • Seoul, Korea, Republic of
        • Department of Surgery, Chung-ang University College of Medicine
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Center for Liver Cancer, National Cancer Center
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Department of Surgery, Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evidence of pancreatic fistula confirmed by serum and drain amylase
Time Frame: within the first 7 days after surgery
within the first 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
within the first 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Sun-Whe Kim, M.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-0908-040-290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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