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Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121338
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Dysautonomia is malfunction of the autonomic nervous system. It usually results from overactivity of the sympathetic portion and over-secretion of acetylcholine. Symptoms depend on the organ involved by this sympathetic overstimulation. Involvement of the gastrointestinal system results in chronic dysmotility, nausea, vomiting, food intolerance, weight loss and need for feeding tube placement and/or parenteral feeding. Autonomic celiac ganglia resection has been shown to alleviate symptoms as it interrupts the sympathetic stimulation to the gastrointestinal (GI) system, however there is no pre surgery test to confirm the diagnosis. The investigators' objective is to temporarily block the celiac ganglion with a long acting anesthetic (liposomal bupivacaine). If symptoms abate the diagnosis is confirmed and patient will proceed to surgery.

Condition or disease Intervention/treatment Phase
Dysautonomia Procedure: Celiac ganglion block Drug: Liposomal bupivacaine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 10 patients with chronic GI dysmotility, chronic nausea/vomiting and feeding intolerance requiring G-J feeding and considered for Celiac Ganglion resection
Masking: None (Open Label)
Masking Description: Since this is a single arm study, no masking will be performed
Primary Purpose: Diagnostic
Official Title: Prospective Single-Arm Pilot Study for CT-Guided, Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: Test group
10 patients with presumptive diagnosis of dysautonomia with chronic nausea, vomiting and food intolerance
Procedure: Celiac ganglion block
The celiac ganglion block will be performed under CT guidance and with the patent under moderate sedation. With the patient prone the back will be prepped and draped sterility. Under CT guidance two 22 gauge needles will be placed with the tips on either side of the celiac artery. This is the location of the celiac ganglia. Liposomal bupivacaine will then be injected in that location. Maximum dose is 133 mg for 75 kg person. For lower weight patients, dose will be weight based. Then patient will be observed for 1-2 hours post procedure and then discharged to home

Drug: Liposomal bupivacaine
Liposomal bupivacaine will then be injected in that location. Maximum dose is 133 mg for 75 kg person. For lower weight patients, dose will be weight based.
Other Name: Exparel




Primary Outcome Measures :
  1. Amount of solid food intake by mouth per day [ Time Frame: 2 days post celiac ganglion block ]
    Over the 2 days post Celiac Ganglion block, the investigators will monitor the patient (outpatient) for amount of solid food intake (grams) per day.

  2. Change in abdominal pain as assessed by patient reported pain on scale 1-10 (10 worse) [ Time Frame: Baseline and 2 days post-celiac ganglion block ]
    Patients with GI involvement of dysautonomia have abdominal pain which is worse with solid food intake. The patient's ability to take solid food without pain will be evaluated on scale 1-10 with 10 being worse pain.


Secondary Outcome Measures :
  1. Number of episodes of nausea/vomiting per day [ Time Frame: 2 days post celiac ganglion block ]
    The frequency of nausea/vomiting will be tabulated.

  2. Change in amount of analgesic medications used [ Time Frame: Baseline and 2 days post celiac ganglion block ]
    Patients with GI dysautonomia have chronic abdominal pain and take almost daily analgesic medication. The investigators shall evaluate the use of analgesic medication for the duration of the Celiac Ganglion block.



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with dysautonomia-related GI dysmotility, misdiagnosed as having MALS after MALS surgery fails to relieve symptoms
  • Patients with known dysautonomia-related dysmotility and related symptoms

Exclusion Criteria:

  • Allergy to liposomal bupivacaine
  • Platelets < 50 thousand
  • International normalised ration (INR) > 1.7

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): NCT04121338


Contacts
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Contact: CHRISTOS GEORGIADES, MD PHD 4106141046 cgeorgi@jhmi.edu
Contact: Beatriz Kohler 4105020738 bkohler@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: CHRISTOS GEORGIADES, MD PHD    410-614-1046    cgeorgi@jhmi.edu   
Contact: BEATRIZ KOHLER    410-502-0738    bkohler@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Christos Georgiades, MD, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04121338    
Other Study ID Numbers: IRB00198738
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Johns Hopkins University:
celiac ganglion block
resection
bowel dysmotility
Additional relevant MeSH terms:
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Ganglion Cysts
Synovial Cyst
Primary Dysautonomias
Autonomic Nervous System Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Nervous System Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents