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Pancreatic Stent to Prevent Leak After Distal Pancreatectomy (LEAPS)
This study is enrolling participants by invitation only.
Study NCT00671463   Information provided by Massachusetts General Hospital
First Received: May 1, 2008   Last Updated: May 2, 2008   History of Changes

May 1, 2008
May 2, 2008
April 2008
April 2010   (final data collection date for primary outcome measure)
Pancreatic leak [ Time Frame: Post-operative day 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00671463 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Pancreatic Stent to Prevent Leak After Distal Pancreatectomy
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.

 
 
Interventional
Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
  • Pancreatic Surgery
  • Pancreatic Duct Stenting
  • Pancreatic Cancer
  • Distal Pancreatectomy
  • Pancreatic Diseases
  • Pancreatic Cyst
  • Pancreatic Ducts
Procedure: Pancreatic duct stenting
  • Experimental: Pre-operative pancreatic duct stenting
  • No Intervention: Control group, no endoscopy and no stent pre-operatively
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Enrolling by invitation
80
 
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00671463
William Brugge, MD / Director of Endoscopy, Massachusetts General Hospital
2007P000965
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
Massachusetts General Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP