Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis

NCT00658736 | Completed Phase 3 Results DMC

• 1 other identifier: CCF IRB 07-729
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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").

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component

  1 month

Study Arms (2)

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.

Drug: Triamcinolone

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.

Drug: Bupivicaine alone

Interventions

Triamcinolone DRUG

Injection of bupivacaine and triamcinolone

1

Bupivicaine alone DRUG

Injection of bupivacaine

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• TAP Pharmaceutical Products Inc.: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Tyler Stevens
• Organization: Cleveland Clinic

stevent@ccf.org

216 445-1996

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 15, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)