Pancreatic Stent to Prevent Leak After Distal Pancreatectomy
NCT00671463 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2013-06-11
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
- Pancreatic Surgery
- Pancreatic Duct Stenting
- Pancreatic Cancer
- Distal Pancreatectomy
- Pancreatic Diseases
- Pancreatic Cyst
- Pancreatic Ducts
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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