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Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis

This study has been completed.
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Tyler Stevens, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00658736
First received: April 9, 2008
Last updated: May 17, 2017
Last verified: May 2017
  Purpose
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
Chronic Pancreatitis Drug: Triamcinolone Drug: Bupivicaine alone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Triple-Blinded Study of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Bupivicaine and Triamcinolone vs. Bupivicaine Alone for the Treatment of Pain in Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by Tyler Stevens, The Cleveland Clinic:

Primary Outcome Measures:
  • Change in Pain Disability Index [ Time Frame: 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 Outcome Measures:
  • Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component [ Time Frame: 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.


Enrollment: 40
Study Start Date: March 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Drug: Triamcinolone
Injection of bupivacaine and triamcinolone
Placebo Comparator: 2
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.
Drug: Bupivicaine alone
Injection of bupivacaine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658736

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
American Society for Gastrointestinal Endoscopy
TAP Pharmaceutical Products Inc.
  More Information

Responsible Party: Tyler Stevens, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00658736     History of Changes
Other Study ID Numbers: CCF IRB 07-729
Study First Received: April 9, 2008
Results First Received: March 13, 2017
Last Updated: May 17, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The IPD will not be shared.

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017