Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility
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ClinicalTrials.gov Identifier: NCT04121338 |
Recruitment Status :
Recruiting
First Posted : October 9, 2019
Last Update Posted : March 26, 2021
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Tracking Information | |||||||||
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First Submitted Date ICMJE | October 8, 2019 | ||||||||
First Posted Date ICMJE | October 9, 2019 | ||||||||
Last Update Posted Date | March 26, 2021 | ||||||||
Actual Study Start Date ICMJE | December 9, 2019 | ||||||||
Estimated Primary Completion Date | April 2, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility | ||||||||
Official Title ICMJE | Prospective Single-Arm Pilot Study for CT-Guided, Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility | ||||||||
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. | ||||||||
Detailed Description | Problem: 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. A partial list of dysautonomia-related conditions is shown below: Affected Level Manifestation Cardiac innervation Postural Orthostatic Tachycardia Syndrome Skin Hyperhidrosis Arteries Raynaud's phenomenon Kidneys Hypertension Small nerve fibers Reflex Sympathetic Dystrophy Pain fibers Complex regional pain syndrome GI system Chronic GI dysmotility/irritable bowel syndrome (IBS) The last one (Chronic GI dysmotility) usually affects young females, presenting after puberty. Symptoms include chronic abdominal pain, intestinal angina, chronic nausea/vomiting, inability to take po, need for total parenteral nutrition (TPN) or G-tube feeding. Further, the patients' condition is often complicated by opioid dependence, malnutrition, weight loss, social isolation etc. Many such patients are misdiagnosed as having Median Arcuate Ligament Syndrome (MALS) and are referred to surgery for ligament release. Though some of the patients do get partial relief, this temporary relief is due to the partial interruption of the sympathetic nerves during surgery. Repeat surgery to complete celiac ganglion resection is often necessary. Occasionally surgeons refer patients for a Computer Tomography (CT) guided temporary celiac ganglion block to confirm (or exclude) sympathetic system dysfunction as the cause of the patients symptoms. However negative or positive predictive value of this test has not been studies rigorously. Research Hypothesis: The investigators' hypothesis is that a low-risk, outpatient test can confirm (or exclude) dysautonomia as the cause of the patient's symptoms. The experimental test is CT-guided, celiac ganglion temporary block with liposomal bupivacaine. Importance of the Research: Some of the patients who are diagnosed as having MALS have in fact dysautonomia and have the wrong surgery. Many other patients with dysautonomia-related GI symptoms are not diagnosed at all and offered only symptomatic treatment. The development of CT-guided, celiac ganglion temporary block with liposomal bupivacaine as a low-risk confirmatory test for dysautonomia-related GI symptoms, will improve surgical outcomes and afford a novel treatment option to many patients. 2. Objectives CT-guided, celiac ganglion temporary block with liposomal bupivacaine will eliminate sympathetic input to the bowel. Its half-life is 24 hours and therefore symptom relief can be distinguished from overlap due to procedural sedation. Primary:
Secondary:
Treatment Description: 1. SELECTION/RECRUITMENT Potential Population Pool (PPP): Adolescents and adults with diagnosis of :
Study Population (Subgroup of PPP):
Must Exclude: Chronic cholecystitis, gastritis, peptic ulcer disease, gastro esophageal reflux, celiac disease, mesenteric atherosclerotic disease, vasculitis, anorexia, depression, other psych issues, etc Complete Compass 31 (Validated Autonomic Function Score) |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A 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
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Condition ICMJE | Dysautonomia | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Test group
10 patients with presumptive diagnosis of dysautonomia with chronic nausea, vomiting and food intolerance
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
10 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 2, 2021 | ||||||||
Estimated Primary Completion Date | April 2, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years to 80 Years (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04121338 | ||||||||
Other Study ID Numbers ICMJE | IRB00198738 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Johns Hopkins University | ||||||||
Study Sponsor ICMJE | Johns Hopkins University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |