Pancreatic Stent to Prevent Leak After Distal Pancreatectomy | NCT00671463

Studies
Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

NCT00671463

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Jun 11, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

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

Interventions

Pancreatic duct stenting

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Anticipated high risk of pancreatitis

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2010Estimated

Completion Date

Not provided

First Submitted Date

May 1, 2008

First Submission Date that Met QC Criteria

May 2, 2008

First Posted Date

May 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2013

Last Update Posted Date

Jun 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

William R. Brugge, MD, Director of Gastrointestinal Endoscopy, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
American Society for Gastrointestinal Endoscopy	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Pre-operative pancreatic duct stenting	Procedure: Pancreatic duct stenting
2	No Intervention	Control group, no endoscopy and no stent pre-operatively

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pancreatic duct stenting	Procedure	In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pancreatic leak		Post-operative day 3

Secondary Outcomes

Measure	Description	Time Frame
Peritoneal fluid analysis		Daily
Serum biochemical analysis		Daily
Clinical outcomes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D010182	Pancreatic Diseases
D010181	Pancreatic Cyst
D007516	Adenoma, Islet Cell

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

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Browse Branches

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