NCT06178315

Brief Summary

The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 7, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

December 8, 2023

Last Update Submit

December 18, 2023

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Rate of adequate pain relief

    Rate of adequate pain relief in patients with chronic pancreatitis undergoing endoscopic ultrasound-guided celiac plexus block or sham procedure. Adequate pain relief is defined as a 50% reduction in composite pain score from baseline, measured using the Brief Pain Inventory-Short Form, at 1 month post-intervention.

    1 month

Secondary Outcomes (11)

  • Technical success

    Immediately after procedure

  • Pain scores measured using Visual Analog Scale.

    3 months

  • Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form.

    3 months

  • Quality of life assessment

    3 months

  • Opioid analgesic use

    3 months

  • +6 more secondary outcomes

Study Arms (2)

Endoscopic ultrasound-guided celiac plexus block

ACTIVE COMPARATOR

EUS-guided celiac plexus block will be performed.

Procedure: EUS-guided celiac plexus block

Sham

SHAM COMPARATOR

Celiac plexus block will not be performed.

Procedure: Sham procedure

Interventions

EUS-guided celiac plexus blockPROCEDURE

Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.

Endoscopic ultrasound-guided celiac plexus block
Sham procedurePROCEDURE

Celiac plexus will not be performed in this arm.

Sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Abdominal pain of at least 3 months duration and a VAS score ≥ 3, with or without the use of narcotic analgesics.
  • Diagnosis of chronic pancreatitis on EUS examination, with ≥ 5 features on EUS.
  • No other cause of abdominal pain

You may not qualify if:

  • Age \< 18 years.
  • History of prior EUS-CPB.
  • Use of anticoagulants that cannot be discontinued for the procedure.
  • Clinically significant allergy to bupivacaine or triamcinolone.
  • Unable to obtain consent for the procedure from either the patient or LAR.
  • Intrauterine pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Related Publications (1)

  • Wilcox CM, Bang JY, Buxbaum J, Gardner TB, Hawes R, Kedia P, Mardini SH, Muniraj T, Navaneethan U, Oza VM, Tarnasky P, Thakkar S, Waxman I, Varadarajulu S; US Pancreatic Disease Study Group. Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial 1. Trials. 2024 Oct 14;25(1):676. doi: 10.1186/s13063-024-08478-y.

    PMID: 39396987DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Charles Melbern Wilcox, MD

CONTACT

321-841-2431Charles.Wilcox@orlandohealth.com

Barbara J Broome

CONTACT

321-841-7031barbara.broome@orlandohealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2023

First Posted

December 21, 2023

Study Start

December 7, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)