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

Not Applicable

Completed

• Conditions: Abdominal Pain; Pancreatitis, Chronic
• Interventions: Procedure: EUS-celiac ganglia block (EUS-CGB); Procedure: EUS-celiac plexus block (EUS-CPB)

• Registration Number: NCT03070210
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2017-01-25
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-celiac ganglia block (EUS-CGB)	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≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn.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.
EUS-celiac plexus block (EUS-CPB)	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.

Primary Outcome Measures

Name	Time	Method
Pain relief	1 week	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".

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States