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NCT Number: NCT02054910

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

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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celiac Plexus Block

Procedure

Patients will receive celiac plexus block during endoscopy.

Sham

Procedure

Patients will not receive celiac plexus block during endoscopy.

Primary outcomes

  1. Change in Pain Response Over a 6 Month Period of Time Using the VAS Score

    Time frame: baseline to 6 months

    Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.

Secondary outcomes

  1. Mean Quality of Life Score Between Each Group at 6 Months

    Time frame: 6 months post baseline

    The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).

  2. Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline

    Time frame: baseline to 6 months

    the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.

  3. Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.

    Time frame: baseline to 6 months

    The Beck's Depression scale was used to indicate subject's depression:

    0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

  4. Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure

    Time frame: baseline to 6 months

    The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group

  5. % of Subjects in Each Group That Are Employed at 6 Months Post Procedure.

    Time frame: baseline to 6 months

    Subjects will be asked about employment at 6 months post procedure

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2014
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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