Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

NCT00671463 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-06-11

No results posted yet for this study

Summary

The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.

Conditions

Interventions

PROCEDURE

Pancreatic duct stenting

In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.

Sponsors & Collaborators

  • American Society for Gastrointestinal Endoscopy

    collaborator OTHER
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Field F Willingham, MD, MPH · MGH

  • Denise W Gee, MD · MGH

  • Sevdenur Cizginer, MD · MGH

  • David W Rattner, MD · MGH

  • William R Brugge, MD · MGH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671463 on ClinicalTrials.gov