Pancreatic Stent to Prevent Leak After Distal Pancreatectomy (LEAPS)

This study has been withdrawn prior to enrollment.
(Anticipated high risk of pancreatitis)
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00671463
First received: May 1, 2008
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Pancreatic Surgery
Pancreatic Duct Stenting
Pancreatic Cancer
Distal Pancreatectomy
Pancreatic Diseases
Pancreatic Cyst
Pancreatic Ducts
Procedure: Pancreatic duct stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Pancreatic leak [ Time Frame: Post-operative day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peritoneal fluid analysis [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Serum biochemical analysis [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Clinical outcomes [ Time Frame: Daily ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pre-operative pancreatic duct stenting
Procedure: Pancreatic duct stenting
In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.
No Intervention: 2
Control group, no endoscopy and no stent pre-operatively

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671463

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Society for Gastrointestinal Endoscopy
Investigators
Study Director: Field F Willingham, MD, MPH MGH
Study Director: Denise W Gee, MD MGH
Study Director: Sevdenur Cizginer, MD MGH
Principal Investigator: David W Rattner, MD MGH
Principal Investigator: William R Brugge, MD MGH
  More Information

No publications provided

Responsible Party: William R. Brugge, MD, Director of Gastrointestinal Endoscopy, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00671463     History of Changes
Other Study ID Numbers: 2007P000965
Study First Received: May 1, 2008
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pancreas surgery
Pancreatic adenocarcinoma
Pancreatic neuroendocrine tumor
Pancreatic duct stenting

Additional relevant MeSH terms:
Pancreatic Cyst
Pancreatic Diseases
Pancreatic Neoplasms
Cysts
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 29, 2014