Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis

NCT ID: NCT00658736

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-01-31

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.

Conditions

Chronic Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Triamcinolone

Intervention Type: DRUG

Injection of bupivacaine and triamcinolone

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.

Group Type: PLACEBO_COMPARATOR

Bupivicaine alone

Intervention Type: DRUG

Injection of bupivacaine

Interventions

Triamcinolone

Injection of bupivacaine and triamcinolone

Intervention Type: DRUG

Bupivicaine alone

Injection of bupivacaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age >18 yrs
• Ability for informed consent
• Chronic pancreatic-type abdominal pain (type B) (11).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role: collaborator

TAP Pharmaceutical Products Inc.

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tyler Stevens

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CCF IRB 07-729

Identifier Type: -

Identifier Source: org_study_id