Pancreatic Stent to Prevent Leak After Distal Pancreatectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 1, 2008

Last Updated Date

May 2, 2008

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00671463 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Official Title ^ICMJE

Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: Pancreatic duct stenting

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00671463

Responsible Party

William Brugge, MD / Director of Endoscopy, Massachusetts General Hospital

Study ID Numbers ^ICMJE

2007P000965

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

American Society for Gastrointestinal Endoscopy

Investigators ^ICMJE

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

Information Provided By

Massachusetts General Hospital

Verification Date

May 2008

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