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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Chronic Pancreatitis

Treatments

Procedure: Sham
Procedure: Celiac Plexus Block

Study type

Interventional

Funder types

Other

Identifiers

NCT02054910
F130822012

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

5 participants in 2 patient groups

Celiac Plexus Block
Experimental group
Description:
Celiac Plexus Block will be administered following EUS
Treatment:
Procedure: Celiac Plexus Block
Sham
Sham Comparator group
Description:
A celiac plexus block will not be administered for pain management
Treatment:
Procedure: Sham

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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