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Pancreatic Stent to Prevent Leak After Distal Pancreatectomy (LEAPS)

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ClinicalTrials.gov Identifier: NCT00671463
Recruitment Status : Withdrawn (Anticipated high risk of pancreatitis)
First Posted : May 5, 2008
Last Update Posted : June 11, 2013
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
William R. Brugge, MD, 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial
Study Start Date : April 2008
Estimated Primary Completion Date : April 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pancreatic leak [ Time Frame: Post-operative day 3 ]

Secondary Outcome Measures :
  1. Peritoneal fluid analysis [ Time Frame: Daily ]
  2. Serum biochemical analysis [ Time Frame: Daily ]
  3. Clinical outcomes [ Time Frame: Daily ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671463

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Society for Gastrointestinal Endoscopy
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

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
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Keywords provided by William R. Brugge, MD, Massachusetts General Hospital:
Pancreas surgery
Pancreatic adenocarcinoma
Pancreatic neuroendocrine tumor
Pancreatic duct stenting

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