Recruiting

EUS-guided Celiac Plexus Block vs. Sham

Sponsor:

Orlando Health, Inc.

Code:

NCT06178315

Conditions

Chronic Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EUS-guided celiac plexus block

Sham procedure

Study Details

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.

Conditions

Chronic Pancreatitis

Study ID

NCT06178315

Start date

Dec 7, 2023

Status verified date

Dec, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Endoscopic ultrasound-guided celiac plexus block

EUS-guided celiac plexus block will be performed.

sham comparator: Sham

Celiac plexus block will not be performed.

Interventions

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.

Sham procedure

Celiac plexus will not be performed in this arm.

Primary outcome measure

  • Rate of adequate pain relief [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Charles Melbern Wilcox, MD

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

Barbara J Broome

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

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Charles Melbern Wilcox, MD

321-841-2431charles.wilcox@orlandohealth.com

Barbara J Broome

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

More Information

Sponsor

Orlando Health, Inc.

Last update posted

Dec 21, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orlando Health, Inc. on 2023-12-21.