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

Study Purpose

AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs.#46;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.#46; EUS-CGB in patients with painful chronic pancreatitis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03070210
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Cleveland Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tyler Stevens, MD
Principal Investigator Affiliation	The Cleveland Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pancreatitis, Chronic, Abdominal Pain

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland Clinic Main Campus, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195

Site Contact

Tyler Stevens, MD

stevent@ccf.org

216-213-0494

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