Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

NCT ID: NCT00671463

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Pre-operative pancreatic duct stenting

Group Type: EXPERIMENTAL

Pancreatic duct stenting

Intervention Type: PROCEDURE

In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.

2

Control group, no endoscopy and no stent pre-operatively

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pancreatic duct stenting

In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

William R. Brugge, MD

Director of Gastrointestinal Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Field F Willingham, MD, MPH

Role: STUDY_DIRECTOR

MGH

Denise W Gee, MD

Role: STUDY_DIRECTOR

MGH

Sevdenur Cizginer, MD

Role: STUDY_DIRECTOR

MGH

David W Rattner, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

William R Brugge, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2007P000965

Identifier Type: -

Identifier Source: org_study_id