Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Pancreatic Cancer Clinical Trial

— LEAPS  

Official title:

Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00671463
• Other study ID #: 2007P000965
• Status: Withdrawn
• Phase: N/A
• First received: May 1, 2008
• Last updated: June 10, 2013
• Start date: April 2008

Study information

• Verified date: June 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Distal Pancreatectomy
• Pancreatic Cancer
• Pancreatic Cyst
• Pancreatic Diseases
• Pancreatic Duct Stenting
• Pancreatic Ducts
• Pancreatic Neoplasms
• Pancreatic Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Society for Gastrointestinal Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic leak		Post-operative day 3	No
Secondary	Peritoneal fluid analysis		Daily	No
Secondary	Serum biochemical analysis		Daily	No
Secondary	Clinical outcomes		Daily	No