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| Name | Class |
|---|---|
| American Society for Gastrointestinal Endoscopy | OTHER |
| TAP Pharmaceutical Products Inc. | INDUSTRY |
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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").
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | EUS guided celiac block with bupivicaine and triamcinolone. Patient will undergo endoscopic ultrasound and celiac plexus blockade using an EUS needle inserted into the celiac plexus. 20 cc of injectate will be administered. |
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| 2 | Placebo Comparator | EUS guided celiac block with bupivicaine only. Patient will undergo endoscopic ultrasound and celiac plexus blockade using an EUS needle inserted into the celiac plexus. 20 cc of injectate will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug | Injection of bupivacaine and triamcinolone |
| |
| Bupivicaine alone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month after block |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria include:
Exclusion criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
The IPD will not be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivicaine Alone | EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution. |
| FG001 | Bupivicaine Plus Triamcinolone | EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution mixed with 80 mg Triamcinolone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivicaine and Triamcinolone | EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone |
| BG001 | Bupivicaine Alone | EUS guided celiac block with bupivicaine only Bupivicaine alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 month after block |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivicaine and Triamcinolone | EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension urgency | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tyler Stevens | Cleveland Clinic | 216 445-1996 | stevent@ccf.org |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
Injection of bupivacaine |
|
| 1 month |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
|
| 0 |
| 21 |
| 4 |
| 21 |
| EG001 | Bupivicaine Alone | EUS guided celiac block with bupivicaine only Bupivicaine alone | 0 | 19 | 2 | 19 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric hematoma | Gastrointestinal disorders | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |