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Pancreatic Stent to Prevent Leak After Distal Pancreatectomy (LEAPS)

Primary Purpose

Pancreatic Surgery, Pancreatic Duct Stenting, Pancreatic Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pancreatic duct stenting

About this trial

This is an interventional prevention trial for Pancreatic Surgery focused on measuring Pancreas surgery, Pancreatic adenocarcinoma, Pancreatic neuroendocrine tumor, Pancreatic duct stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Pre-operative pancreatic duct stenting

Control group, no endoscopy and no stent pre-operatively

Outcomes

Primary Outcome Measures

Pancreatic leak

Secondary Outcome Measures

Peritoneal fluid analysis

Serum biochemical analysis

Clinical outcomes

Full Information

NCT ID

NCT00671463

First Posted

May 1, 2008

Last Updated

June 10, 2013

Sponsor

Massachusetts General Hospital

Collaborators

American Society for Gastrointestinal Endoscopy

1. Study Identification

Unique Protocol Identification Number

NCT00671463

Brief Title

Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Acronym

LEAPS

Official Title

Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Anticipated high risk of pancreatitis

Study Start Date

April 2008 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

American Society for Gastrointestinal Endoscopy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Pre-operative pancreatic duct stenting

Arm Title

Arm Type

No Intervention

Arm Description

Control group, no endoscopy and no stent pre-operatively

Intervention Type

Procedure

Intervention Name(s)

Pancreatic duct stenting

Intervention Description

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

Primary Outcome Measure Information:

Title

Pancreatic leak

Time Frame

Post-operative day 3

Secondary Outcome Measure Information:

Title

Peritoneal fluid analysis

Time Frame

Daily

Title

Serum biochemical analysis

Time Frame

Daily

Title

Clinical outcomes

Time Frame

Daily

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: