Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Withdrawn before enrolling · Not applicable

Conditions studied: Pancreatic Surgery, Pancreatic Duct Stenting, Pancreatic Cancer, Distal Pancreatectomy, Pancreatic Diseases, Pancreatic Cyst, Pancreatic Ducts

In brief

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.

Key facts

Study ID

NCT00671463

Run by

Massachusetts General Hospital

People needed

0

Starts

2008-04-01

Last updated by the study team

2013-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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