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Sponsors and Collaborators: |
The Cleveland Clinic American Society for Gastrointestinal Endoscopy TAP pharmaceuticals (sponsor of the ASGE grant award) |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00658736 |
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").
Condition | Intervention | Phase |
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Chronic Pancreatitis |
Drug: Triamcinolone Drug: Bupivicaine alone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A RANDOMIZED, TRIPLE-BLINDED STUDY OF ENDOSCOPIC ULTRASOUND GUIDED CELIAC PLEXUS BLOCKADE (EUS-CPB) WITH BUPIVICAINE AND TRIAMCINOLONE VS. BUPIVICAINE ALONE FOR TREATMENT OF PAIN IN CHRONIC PANCREATITIS |
Estimated Enrollment: | 72 |
Study Start Date: | March 2008 |
Arms | Assigned Interventions |
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1: Experimental
EUS guided celiac block with bupivicaine and triamcinolone
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Drug: Triamcinolone |
2: Placebo Comparator
EUS guided celiac block with bupivicaine only
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Drug: Bupivicaine alone |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria include:
Exclusion criteria include:
Contact: Adele Costanza | 216-445-3851 |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Stacey Pallotta 216-445-7488 pallots@ccf.org | |
Principal Investigator: Tyler Stevens, M.D. |
Responsible Party: | Cleveland Clinic Foundation ( Tyler Stevens, M.D. ) |
Study ID Numbers: | CCF IRB 07-729 |
Study First Received: | April 9, 2008 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00658736 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Inflammatory Agents Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Depressants Anesthetics Pain Triamcinolone diacetate Immunosuppressive Agents Hormones Glucocorticoids |
Anesthetics, Local Triamcinolone hexacetonide Digestive System Diseases Triamcinolone Acetonide Triamcinolone Pancreatic Diseases Celiac Disease Bupivacaine Peripheral Nervous System Agents Pancreatitis Pancreatitis, Chronic |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anesthetics Hormones Triamcinolone hexacetonide Triamcinolone Acetonide Sensory System Agents Therapeutic Uses Triamcinolone Central Nervous System Depressants |
Triamcinolone diacetate Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Anesthetics, Local Pharmacologic Actions Digestive System Diseases Pancreatic Diseases Bupivacaine Peripheral Nervous System Agents Central Nervous System Agents Pancreatitis Pancreatitis, Chronic |