Pancreatic Stent to Prevent Leak After Distal Pancreatectomy
Sponsored by Massachusetts General Hospital
About this trial
Last updated 13 years ago
Study ID
2007P000965
Status
Withdrawn
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Started 18 years ago
What is this trial about?
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.
What are the participation requirements?
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