Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Pancreatic leak
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (greater than or equal to 18 years of age)
- •Scheduled to undergo an elective laparoscopic or open distal pancreatectomy
- •Willing to undergo pre-operative endoscopy
- •Consenting to the procedure
Exclusion Criteria
- •Contraindication to abdominal surgery
- •Contraindication to general anesthesia or distal pancreatectomy
- •Contraindication to upper endoscopy or ERCP
- •Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP
- •Ongoing pancreatitis
- •Pancreatic necrosis or abscess
- •History of sphincter of Oddi dysfunction
- •History of ERCP-induced pancreatitis
Arms & Interventions
1
Pre-operative pancreatic duct stenting
Intervention: Pancreatic duct stenting (Procedure)
2
Control group, no endoscopy and no stent pre-operatively
Outcomes
Primary Outcomes
Pancreatic leak
Time Frame: Post-operative day 3
Secondary Outcomes
- Peritoneal fluid analysis(Daily)
- Serum biochemical analysis(Daily)
- Clinical outcomes(Daily)
Investigators
William R. Brugge, MD
Director of Gastrointestinal Endoscopy
Massachusetts General Hospital