Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis

A Randomized, Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Standard Plexus Injection vs. Direct Celiac Ganglia Block for Treatment of Pain in Chronic Pancreatitis.

AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB).

METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Pancreatitis, Chronic
• Intervention / Treatment: Procedure: EUS-celiac plexus block (EUS-CPB); Procedure: EUS-celiac ganglia block (EUS-CGB)

Detailed Description

Inclusion criteria include: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.

Exclusion criteria include: 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with chronic pancreatitis and referred for EUS-guided celiac plexus block with: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: EUS-celiac plexus block (EUS-CPB); This is the standard technique. In this approach, the needle is passed through the body of the stomach adjacent the celiac artery into the retroperitoneal space in 1 or 2 passes. The injectate (bupivacaine or alcohol) is injected and spreads through the retroperitoneal space, effectively "bathing" all the ganglia.	Procedure: EUS-celiac plexus block (EUS-CPB); In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space.
ACTIVE_COMPARATOR: EUS-celiac ganglia block (EUS-CGB); This is a more recent technique which has been often used. In this procedure, the needle is inserted under EUS guidance directly into as many ganglia as possible. For celiac ganglia <1cm in diameter, the solution is injected into the central point; for those ≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn. Injections are continued until an echogenic pattern is produced over the entire celiac ganglia.	Procedure: EUS-celiac ganglia block (EUS-CGB); The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	The primary endpoint will be pain relief at 1 week after the block, defined as a decrease of 3 or more points in the VAS scale measuring "average pain over past week".	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate	Decrease in pain to 1 or 0.	1 week
Duration of pain relief	Duration of pain relief will be assessed during a 2-month follow-up.	up to 2 months
Opioid consumption	Assess the opioid consumption in up to 2 months after endoscopic therapy.	up to 2 months
Adverse effects	Assess the incidence of adverse effects after endoscopic therapy.	in up to 2 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Study Director: Tyler Stevens, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Doi S, Yasuda I, Kawakami H, Hayashi T, Hisai H, Irisawa A, Mukai T, Katanuma A, Kubota K, Ohnishi T, Ryozawa S, Hara K, Itoi T, Hanada K, Yamao K. Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial. Endoscopy. 2013;45(5):362-9. doi: 10.1055/s-0032-1326225. Epub 2013 Apr 24.
• Ascunce G, Ribeiro A, Reis I, Rocha-Lima C, Sleeman D, Merchan J, Levi J. EUS visualization and direct celiac ganglia neurolysis predicts better pain relief in patients with pancreatic malignancy (with video). Gastrointest Endosc. 2011 Feb;73(2):267-74. doi: 10.1016/j.gie.2010.10.029.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2017
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pancreatic Diseases; Abdominal Pain; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 16-1543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No