Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis
NCT ID: NCT03070210
Last Updated: 2020-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2017-01-25
2019-08-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
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.
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≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn.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 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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Tyler Stevens
Director of Advanced Endoscopy Fellowship Program
Principal Investigators
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Tyler Stevens, MD
Role: STUDY_DIRECTOR
The Cleveland Clinic
Locations
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Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Countries
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References
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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.
Other Identifiers
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16-1543
Identifier Type: -
Identifier Source: org_study_id
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