Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT03070210|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Chronic Abdominal Pain||Procedure: EUS-celiac ganglia block (EUS-CGB) Procedure: EUS-celiac plexus block (EUS-CPB)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official 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.|
|Actual Study Start Date :||January 25, 2017|
|Estimated Primary Completion Date :||February 25, 2020|
|Estimated Study Completion Date :||August 25, 2020|
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.
- 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".
- Complete response rate [ Time Frame: 1 week ]Decrease in pain to 1 or 0.
- Duration of pain relief [ Time Frame: up to 2 months ]Duration of pain relief will be assessed during a 2-month follow-up.
- Opioid consumption [ Time Frame: up to 2 months ]Assess the opioid consumption in up to 2 months after endoscopic therapy.
- Adverse effects [ Time Frame: in up to 2 months ]Assess the incidence of adverse effects after endoscopic therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070210
|Contact: Tyler Stevens, MD||(216) 445-1996||STEVENT@ccf.org|
|United States, Ohio|
|Cleveland Clinic Main Campus||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Tyler Stevens, MD 216-213-0494 firstname.lastname@example.org|
|Study Director:||Tyler Stevens, MD||The Cleveland Clinic|