Chronic Pancreatitis
Conditions
Brief summary
This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain. The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone (therapeutic block). There control group will undergo EUS-CPB with bupivicaine alone (diagnostic block).
Detailed description
There are few effective options for the treatment of abdominal pain in chronic pancreatitis. For the past 20 years, percutaneous injection of anesthetic agents into the celiac plexus (celiac plexus blockade or CPB) has been performed by pain anesthesiologists to diagnose the origin of pancreatic pain (visceral vs. non-visceral). Anesthetic blocks provide very short-term and variable pain relief. More recently, endoscopic ultrasound has been used to provide a transgastric approach to the celiac plexus (EUS-CPB). Corticosteroids may lengthen the effect of CPB to provide longer-lasting pain relief (therapeutic block). Case-series report that about 50% of patients experience partial or complete relief lasting an average of 1-2 months. Combined corticosteroid (triamcinolone) and anesthetic (bupivicaine) has now become standard practice for EUS-CPB. However, there have been no randomized controlled trials to prove that corticosteroid blocks are truly therapeutic (i.e. that they lengthen the effect of the typical diagnostic CPB with anesthetics). Randomized controlled trials are needed to demonstrate the therapeutic efficacy of CPB with corticosteroids. This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain. The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone (therapeutic block). There control group will undergo EUS-CPB with bupivicaine alone (diagnostic block). Eligible patients with abdominal pain undergoing EUS for the diagnosis of chronic pancreatitis or EUS-CPB for pancreatic pain will be recruited. Patients will complete a 2-week run-in period to establish baseline pain scores and opioid consumption. Following the run-in, EUS will be performed. If EUS reveals CP (\>4 criteria), patients will be randomized to one of the two treatment groups. 74 patients will be randomized and followed for 2 months after the EUS-CPB. The primary endpoint is an improvement in the pain disability index (PDI) of greater than 10 points at 1 month. Secondary endpoints include opioid consumption, duration of pain relief, and quality of life (SF-12). If this trial shows that the addition of triamcinolone produces a long-lasting (1-month) benefit, then EUS-CPB can be more strongly advocated as a therapeutic option to patients with chronic pancreatitis. If triamcinolone does not produce a benefit over a diagnostic block, then EUS-CPB should be considered a primarily diagnostic measure for differentiation of visceral from non-visceral pain.
Interventions
DRUGTriamcinolone
Injection of bupivacaine and triamcinolone
DRUGBupivicaine alone
Injection of bupivacaine
Sponsors
American Society for Gastrointestinal Endoscopy
TAP Pharmaceutical Products Inc.
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include: * Age \>18 yrs * Ability for informed consent * Chronic pancreatic-type abdominal pain (type B) (11).
Exclusion criteria
include: * Pregnancy * Malignancy * Recent acute pancreatitis (within 2 months) * Elevated INR (\>1.5) or low platelet count (\<75 cells/mm3) * Allergy to eggs or caine anesthetics or corticosteroids; AND * Becks depression score\>20.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Disability Index | 1 month after block | The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component | 1 month | The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivicaine and Triamcinolone EUS guided celiac block with bupivicaine and triamcinolone
Triamcinolone | 21 |
| Bupivicaine Alone EUS guided celiac block with bupivicaine only
Bupivicaine alone | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Bupivicaine and Triamcinolone | Bupivicaine Alone | Total |
|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 10.9 | 44.1 years STANDARD_DEVIATION 12.5 | 41.7 years STANDARD_DEVIATION 11.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 21 | 2 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
Change in Pain Disability Index
The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.
Time frame: 1 month after block
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivicaine and Triamcinolone | Change in Pain Disability Index | 3 Participants |
| Bupivicaine Alone | Change in Pain Disability Index | 3 Participants |
Secondary
Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component
The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine and Triamcinolone | Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component | -0.2 units on a scale | Standard Deviation 7.5 |
| Bupivicaine Alone | Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component | 1.7 units on a scale | Standard Deviation 8.8 |