Official Title: “Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial”

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 Type: Interventional

Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Procedure: Pancreatic duct stenting
  • In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pre-operative pancreatic duct stenting
• No Intervention: 2
  • Control group, no endoscopy and no stent pre-operatively

Primary Measures

• Pancreatic leak
  • Time Frame: Post-operative day 3
    Safety Issue?: No

Secondary Measures

• Peritoneal fluid analysis
  • Time Frame: Daily
    Safety Issue?: No
• Serum biochemical analysis
  • Time Frame: Daily
    Safety Issue?: No
• Clinical outcomes
  • Time Frame: Daily
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

Field F Willingham, MD, MPH Study Director MGH  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00671463

Study ID Number: 2007P000965

ClinicalTrials.gov Identifier: NCT00671463

Health Authority: United States: Institutional Review Board