CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

NCT ID: NCT02054910

Last Updated: 2017-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.

Detailed Description

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The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.

Conditions

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Chronic Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Celiac Plexus Block

Celiac Plexus Block will be administered following EUS

Group Type EXPERIMENTAL

Celiac Plexus Block

Intervention Type PROCEDURE

Patients will receive celiac plexus block during endoscopy.

Sham

A celiac plexus block will not be administered for pain management

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

Patients will not receive celiac plexus block during endoscopy.

Interventions

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Celiac Plexus Block

Patients will receive celiac plexus block during endoscopy.

Intervention Type PROCEDURE

Sham

Patients will not receive celiac plexus block during endoscopy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
* Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).

Exclusion Criteria

* Age \<19 years
* Unable to safely undergo EUS for any reason
* Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml)
* Unable to consent
* Non-English speaking patients.
* Previously undergone CPB
* Pregnancy and Breast feeding
* Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
* Previous pancreatic surgery
* Previous pseudocyst drainage
* Other documented causes of abdominal pain.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Charles Mel Wilcox, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles M Wilcox, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F130822012

Identifier Type: -

Identifier Source: org_study_id

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