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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
Sponsor:
Information provided by (Responsible Party):
Tyler Stevens, 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.


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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Tyler Stevens, MD (216) 445-1996 STEVENT@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Main Campus Recruiting
Cleveland, Ohio, United States, 44195
Contact: Tyler Stevens, MD    216-213-0494    stevent@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Study Director: Tyler Stevens, MD The Cleveland Clinic

Publications:
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Responsible Party: Tyler Stevens, Director of Advanced Endoscopy Fellowship Program, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03070210     History of Changes
Other Study ID Numbers: 16-1543
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Abdominal Pain
Pancreatic Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents