Endoscopic Stenting for Chronic Abdominal Pain | NCT00754676

Studies
Endoscopic Stenting for Chronic Abdominal Pain

NCT00754676

Sponsor

Leigh Powell

Status

Completed

Last Update Posted

Oct 10, 2023Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Chronic Pancreatitis

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
5K24DK070629-05	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Sep 17, 2008

First Submission Date that Met QC Criteria

Sep 17, 2008

First Posted Date

Sep 18, 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

Oct 6, 2023

Last Update Posted Date

Oct 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leigh Powell, Principle Investigator, University of Alabama at BirminghamSponsor-Investigator

Lead Sponsor

Leigh PowellOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
University of Alabama at Birmingham	OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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 prospective sham randomized study will evaluate the role of endoscopic stenting inpatients with chronic pancreatitis and chronic abdominal pain.

Detailed Description

Endoscopic stenting is increasingly used for the treatment of a variety of pancreatic disorders. Although a number of studies suggest that pancreatic stenting relieves abdominal pain in approximately 70% of patients, there has been no randomized study. Since any intervention may improve pain, the effectiveness of endoscopy cannot be ascertained without a true placebo arm or sham therapy group.

The study will aim to determine the effectiveness of pancreatic stents in relieving chronic pain in the setting of chronic pancreatitis. Since these procedures do carry risk, a placebo controlled fashion is used for this study

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients referred to the principal investigator for chronic pancreatitis will be enrolled.

Exclusion Criteria:

There are no gender nor racial exclusion.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men and women diagnosed with chronic pancreatitis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles M Wilcox, M.D.	University of Alabama at Birmingham	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided