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EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis

NCT ID: NCT06178315

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-07

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Chronic pancreatitis is a complex fibroinflammatory disease arising from numerous etiological factors and a variety of clinical manifestations. Abdominal pain is the most debilitating complication and can result in significant morbidity and impact on quality of life. Endoscopic ultrasonography (EUS) has been increasingly utilized for celiac plexus block (EUS-CPB), whereby a steroid in combination with a local anesthetic agent are injected into the celiac plexus within the abdominal cavity. 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.

Conditions

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Chronic Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Endoscopic ultrasound-guided celiac plexus block

EUS-guided celiac plexus block will be performed.

Group Type ACTIVE_COMPARATOR

EUS-guided celiac plexus block

Intervention Type PROCEDURE

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

Sham

Celiac plexus block will not be performed.

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type PROCEDURE

Celiac plexus will not be performed in this arm.

Interventions

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EUS-guided celiac plexus block

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

Intervention Type PROCEDURE

Sham procedure

Celiac plexus will not be performed in this arm.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Health, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Charles Melbern Wilcox, MD

Role: CONTACT

Phone: 321-841-2431

Email: [email protected]

Barbara J Broome

Role: CONTACT

Phone: 321-841-7031

Email: [email protected]

Facility Contacts

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Charles Melbern Wilcox, MD

Role: primary

Barbara J Broome

Role: backup

References

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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.

Reference Type DERIVED
PMID: 39396987 (View on PubMed)

Other Identifiers

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2103069

Identifier Type: -

Identifier Source: org_study_id