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Completed

NCT Number: NCT03070210

Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus 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.

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Key information

Conditions

Pancreatitis, Chronic Abdominal Pain Chronic Disease Digestive System Diseases Disease Attributes Neurologic Manifestations Pain Pancreatic Diseases Pancreatitis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EUS-celiac ganglia block (EUS-CGB)

Procedure

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.

EUS-celiac plexus block (EUS-CPB)

Procedure

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.

Primary outcomes

  1. Pain relief

    Time frame: 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 outcomes

  1. Complete response rate

    Time frame: 1 week

    Decrease in pain to 1 or 0.

  2. Duration of pain relief

    Time frame: up to 2 months

    Duration of pain relief will be assessed during a 2-month follow-up.

  3. Opioid consumption

    Time frame: up to 2 months

    Assess the opioid consumption in up to 2 months after endoscopic therapy.

  4. Adverse effects

    Time frame: in up to 2 months

    Assess the incidence of adverse effects after endoscopic therapy.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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