Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

NCT00671463 | Withdrawn DMC

• 1 other identifier: 2007P000965
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreas surgery; Pancreatic adenocarcinoma; Pancreatic neuroendocrine tumor; Pancreatic duct stenting

Outcome Measures

Primary Outcomes (1)

• Pancreatic leak

  Post-operative day 3

Secondary Outcomes (3)

• Peritoneal fluid analysis

  Daily

• Serum biochemical analysis

  Daily

• Clinical outcomes

  Daily

Study Arms (2)

1

EXPERIMENTAL

Pre-operative pancreatic duct stenting

Procedure: Pancreatic duct stenting

2

NO INTERVENTION

Control group, no endoscopy and no stent pre-operatively

Interventions

Pancreatic duct stenting PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Diseases; Pancreatic Cyst; Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases; Cysts; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Field F Willingham, MD, MPH

  MGH

  STUDY DIRECTOR

• Denise W Gee, MD

  MGH

  STUDY DIRECTOR

• Sevdenur Cizginer, MD

  MGH

  STUDY DIRECTOR

• David W Rattner, MD

  MGH

  PRINCIPAL INVESTIGATOR

• William R Brugge, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastrointestinal Endoscopy

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

US (1)