Pancreatic Stent to Prevent Leak After Distal Pancreatectomy - Tabular View

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Pancreatic Stent to Prevent Leak After Distal Pancreatectomy (LEAPS)

This study is enrolling participants by invitation only.

Study NCT00671463. Last updated on May 2, 2008. Information provided by Massachusetts General Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

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

Intervention ^†

Procedure: Pancreatic duct stenting

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Enrolling by invitation

Enrollment ^†

Start Date ^†

April 2008

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00671463

Organization ID

2007P000965

Secondary IDs ^††

Study Sponsor ^†

Massachusetts General Hospital

Collaborators ^††

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

Information Provided By

Massachusetts General Hospital

Verification Date

May 2008

First Received Date ^†

May 1, 2008

Last Updated Date

May 2, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.