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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02054910
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Procedure: Celiac Plexus Block; Procedure: Sham	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celiac Plexus Block Celiac Plexus Block will be administered following EUS	Procedure: Celiac Plexus Block; Patients will receive celiac plexus block during endoscopy.
Sham Comparator: Sham A celiac plexus block will not be administered for pain management	Procedure: Sham; Patients will not receive celiac plexus block during endoscopy.

Outcome Measures

Primary Outcome Measures

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

1. Mean Quality of Life Score Between Each Group at 6 Months [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 [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. [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 [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. [baseline to 6 months]

   Subjects will be asked about employment at 6 months post procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Charles M Wilcox, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Charles Mel Wilcox, MD, Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02054910
• Other Study ID Numbers: F130822012
• First Posted: Feb 4, 2014
• Last Update Posted: Feb 28, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic

Study Results

Participant Flow

Arm/Group Title	Celiac Plexus Block	Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS Celiac Plexus Block	A celiac plexus block will not be administered for pain management Sham
Period Title: Overall Study
STARTED	4	1
COMPLETED	0	0
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Celiac Plexus Block	Sham	Total
Arm/Group Description	Celiac Plexus Block will be administered following EUS Celiac Plexus Block	A celiac plexus block will not be administered for pain management Sham	Total of all reporting groups
Overall Participants	4	1	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 75%	0 0%	3 60%
>=65 years	1 25%	1 100%	2 40%
Gender (Count of Participants)
Female	3 75%	1 100%	4 80%
Male	1 25%	0 0%	1 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 50%	0 0%	2 40%
White	2 50%	1 100%	3 60%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	1 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
Description	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.
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject

Arm/Group Title	Celiac Plexus Block	Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS Celiac Plexus Block	A celiac plexus block will not be administered for pain management Sham
Measure Participants	0	0

2. Secondary Outcome

Title	Mean Quality of Life Score Between Each Group at 6 Months
Description	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).
Time Frame	6 months post baseline

Outcome Measure Data

Analysis Population Description

All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject

Arm/Group Title	Celiac Plexus Block	Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS Celiac Plexus Block	A celiac plexus block will not be administered for pain management Sham
Measure Participants	0	0

3. Secondary Outcome

Title	Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
Description	the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject

Arm/Group Title	Celiac Plexus Block	Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS	A celiac plexus block will not be administered for pain management
Measure Participants	0	0

4. Secondary Outcome

Title	Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.
Description	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.
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject

Arm/Group Title	Celiac Plexus Block	Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS	A celiac plexus block will not be administered for pain management
Measure Participants	0	0

5. Secondary Outcome

Title	Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
Description	The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

All subjects were lost to follow up by 6 months; since everyone dropped out at different times before the 6 month point, the data would not be evaluable.

Arm/Group Title	Celiac Plexus Block	Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS	A celiac plexus block will not be administered for pain management
Measure Participants	0	0

6. Secondary Outcome

Title	% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Description	Subjects will be asked about employment at 6 months post procedure
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject

Arm/Group Title	Celiac Plexus Block	Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS	A celiac plexus block will not be administered for pain management
Measure Participants	0	0

Adverse Events

Time Frame	24-48 hour, 2 week, 6 month, 12 month
Arm/Group Title	Celiac Plexus Block		Sham
Arm/Group Description	Celiac Plexus Block will be administered following EUS Celiac Plexus Block		A celiac plexus block will not be administered for pain management Sham
All Cause Mortality
	Celiac Plexus Block		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Celiac Plexus Block		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Celiac Plexus Block		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.