Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Not Applicable

Withdrawn

• Conditions: Pancreatic Surgery; Pancreatic Duct Stenting; Pancreatic Cancer; Distal Pancreatectomy; Pancreatic Diseases; Pancreatic Cyst; Pancreatic Ducts
• Interventions: Procedure: Pancreatic duct stenting

• Registration Number: NCT00671463
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Primary Completion: 2010-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pancreatic duct stenting	Pre-operative pancreatic duct stenting

Primary Outcome Measures

Name	Time	Method
Pancreatic leak	Post-operative day 3

Secondary Outcome Measures

Name	Time	Method
Peritoneal fluid analysis	Daily
Serum biochemical analysis	Daily
Clinical outcomes	Daily

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States