Chronic Pancreatitis
Conditions
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.
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.
Interventions
PROCEDURECeliac Plexus Block
Patients will receive celiac plexus block during endoscopy.
PROCEDURESham
Patients will not receive celiac plexus block during endoscopy.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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 |
| % 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celiac Plexus Block Celiac Plexus Block will be administered following EUS
Celiac Plexus Block | 4 |
| Sham A celiac plexus block will not be administered for pain management
Sham | 1 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
Baseline characteristics
| Characteristic | Sham | Celiac Plexus Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 3 Participants | 3 Participants |
| Gender Female | 1 Participants | 3 Participants | 4 Participants |
| Gender Male | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 1 participants | 4 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 1 |
| serious Total, serious adverse events | 0 / 4 | 0 / 1 |
Outcome results
Primary
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
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
Population: All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject
Secondary
Mean Mental State Between Groups Using the Beck's Depression Index at 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.
Time frame: baseline to 6 months
Population: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Secondary
Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
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
Population: 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.
Secondary
Mean Quality of Life Score Between Each Group at 6 Months
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
Population: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Secondary
Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Time frame: baseline to 6 months
Population: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Secondary
% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Subjects will be asked about employment at 6 months post procedure
Time frame: baseline to 6 months
Population: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject