Trial Outcomes & Findings for CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis (NCT NCT02054910)
NCT ID: NCT02054910
Last Updated: 2017-02-28
Results Overview
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.
COMPLETED
NA
5 participants
baseline to 6 months
2017-02-28
Participant Flow
Participant milestones
| Measure |
Celiac Plexus Block
Celiac Plexus Block will be administered following EUS
Celiac Plexus Block
|
Sham
A celiac plexus block will not be administered for pain management
Sham
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Celiac Plexus Block
Celiac Plexus Block will be administered following EUS
Celiac Plexus Block
|
Sham
A celiac plexus block will not be administered for pain management
Sham
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Celiac Plexus Block
n=4 Participants
Celiac Plexus Block will be administered following EUS
Celiac Plexus Block
|
Sham
n=1 Participants
A celiac plexus block will not be administered for pain management
Sham
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Gender
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 monthsPopulation: All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: 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.
The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Subjects will be asked about employment at 6 months post procedure
Outcome measures
Outcome data not reported
Adverse Events
Celiac Plexus Block
Sham
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place