Pancreatic Stent to Prevent Leak After Distal Pancreatectomy - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	American Society for Gastrointestinal Endoscopy
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00671463

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:

MedlinePlus related topics: Cancer Endoscopy Pancreatic Cancer Pancreatic Diseases

U.S. FDA Resources

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 ]

Estimated Enrollment:	80
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

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 Brugge, MD / Director of Endoscopy, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00671463 History of Changes
Other Study ID Numbers:	2007P000965
Study First Received:	May 1, 2008
Last Updated:	May 2, 2008
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
Neoplasms

Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 12, 2012