Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04121338
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2019-10-08
Brief Title:
Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Raynauds phenomenon Kidneys Hypertension Small nerve fibers Reflex Sympathetic Dystrophy Pain fibers Complex regional pain syndrome GI system Chronic GI dysmotilityirritable bowel syndrome IBS The last one Chronic GI dysmotility usually affects young females presenting after puberty Symptoms include chronic abdominal pain intestinal angina chronic nauseavomiting 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 patients 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
1 Improved tolerance to per os PO solid food intake
2 Decrease in abdominal pain both at baseline and that associated with PO intake
Secondary
1 Decreaseelimination of pre-existing nauseavomiting frequency and severity
2 Decreaseelimination of analgesic use
3 Background
Experience with Procedure
CT-guided celiac ganglion temporary block with liposomal bupivacaine The PI Dr Georgiades has performed CT-guided nerve blocks hundreds of times including celiac ganglion block over the past 15 years Nerve and specifically celiac ganglion block is an approved procedure for abdominal pain treatment and is performed by Interventional Radiology at Johns Hopkins Dr Georgiades is a full time faculty in the Division of Interventional Radiology He has privileges for performing CT-guided Celiac Ganglion block as well as conscious sedation Dr Georgiades will be the only investigator performing this procedure in the test population
Clinical Data with medication
Liposomal bupivacaine has long been used as an effective local analgesic especially in orthopedic and plastic surgery
Clinical Data Celiac ganglion block
Celiac ganglion block has been used for over a century for the treatment of abdominal pain CT-guided celiac ganglion block has been introduced in the 1950s and most commonly performed with a combination of lidocaine and alcohol for permanent celiac ablation
Experience with Medication
Liposomal bupivacaine is an food and drug administration FDA approved drug and has long been used as a local anesthetic It is simply a long acting formulation of bupivacaine Bupivacaines half-life is 27 hours Since the procedure is performed under conscious sedation the effects of bupivacaine cannot be distinguished from those of the medication given for sedation Versed and fentanyl The half-life of liposomal bupivacaine on the other hand is approximately 24 hours Therefore any symptom relief on post-test day 1 or 2 can be attributed to celiac ganglion blockade and not to sedation medication
Liposomal bupivacaine is available in 266 mg vials which is the maximum recommended single dose for adults
4 Study Procedures a Study design including the sequence and timing of study procedures distinguish research procedures from those that are part of routine care The research protocol is highlighted in light brown below All else is part of the patients standard of care treatment There are two potential patient populations than are candidates for the research protocol 1 those with dysautonomia-related GI dysmotility misdiagnosed as having MALS after MALS surgery fails to relieve symptoms and 2 those with known dysautonomia-related dysmotility and related symptoms The research procedure includes the CT-guided celiac ganglion block only This test will be used to confirm or exclude dysautonomia as the patients cause of GI symptoms Those who have symptom relief after the test block will proceed with open celiac ganglion resection
Treatment Description
1 SELECTIONRECRUITMENT
Potential Population Pool PPP
Adolescents and adults with diagnosis of
1 Median Arcuate Ligament Syndrome MALS
2 Both MALS Postural orthostatic Tachycardia Syndrome POTS
3 POTS or other Dysautonomia symptoms bowel dysmotility
Study Population Subgroup of PPP
1 MALS patients with little or no improvement after laparoscopic arcuate ligament release
2 MALS POTS patients with little or no improvement after laparoscopic arcuate ligament release
3 POTSDysautonomia patients with bowel dysmotility Symptoms Required Chronic nausea food intolerance abdominal pain Additional Chronic vomiting need for enteral or parenteral Nutrition hyperhidrosis complex regional pain syndrome Raynauds Exclusion Criteria Evidence for non-dysautonomia related causes of the patients symptoms
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
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 Raynauds phenomenon Kidneys Hypertension Small nerve fibers Reflex Sympathetic Dystrophy Pain fibers Complex regional pain syndrome GI system Chronic GI dysmotilityirritable bowel syndrome IBS The last one Chronic GI dysmotility usually affects young females presenting after puberty Symptoms include chronic abdominal pain intestinal angina chronic nauseavomiting 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 patients 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
1 Improved tolerance to per os PO solid food intake
2 Decrease in abdominal pain both at baseline and that associated with PO intake
Secondary
1 Decreaseelimination of pre-existing nauseavomiting frequency and severity
2 Decreaseelimination of analgesic use
3 Background
Experience with Procedure
CT-guided celiac ganglion temporary block with liposomal bupivacaine The PI Dr Georgiades has performed CT-guided nerve blocks hundreds of times including celiac ganglion block over the past 15 years Nerve and specifically celiac ganglion block is an approved procedure for abdominal pain treatment and is performed by Interventional Radiology at Johns Hopkins Dr Georgiades is a full time faculty in the Division of Interventional Radiology He has privileges for performing CT-guided Celiac Ganglion block as well as conscious sedation Dr Georgiades will be the only investigator performing this procedure in the test population
Clinical Data with medication
Liposomal bupivacaine has long been used as an effective local analgesic especially in orthopedic and plastic surgery
Clinical Data Celiac ganglion block
Celiac ganglion block has been used for over a century for the treatment of abdominal pain CT-guided celiac ganglion block has been introduced in the 1950s and most commonly performed with a combination of lidocaine and alcohol for permanent celiac ablation
Experience with Medication
Liposomal bupivacaine is an food and drug administration FDA approved drug and has long been used as a local anesthetic It is simply a long acting formulation of bupivacaine Bupivacaines half-life is 27 hours Since the procedure is performed under conscious sedation the effects of bupivacaine cannot be distinguished from those of the medication given for sedation Versed and fentanyl The half-life of liposomal bupivacaine on the other hand is approximately 24 hours Therefore any symptom relief on post-test day 1 or 2 can be attributed to celiac ganglion blockade and not to sedation medication
Liposomal bupivacaine is available in 266 mg vials which is the maximum recommended single dose for adults
4 Study Procedures a Study design including the sequence and timing of study procedures distinguish research procedures from those that are part of routine care The research protocol is highlighted in light brown below All else is part of the patients standard of care treatment There are two potential patient populations than are candidates for the research protocol 1 those with dysautonomia-related GI dysmotility misdiagnosed as having MALS after MALS surgery fails to relieve symptoms and 2 those with known dysautonomia-related dysmotility and related symptoms The research procedure includes the CT-guided celiac ganglion block only This test will be used to confirm or exclude dysautonomia as the patients cause of GI symptoms Those who have symptom relief after the test block will proceed with open celiac ganglion resection
Treatment Description
1 SELECTIONRECRUITMENT
Potential Population Pool PPP
Adolescents and adults with diagnosis of
1 Median Arcuate Ligament Syndrome MALS
2 Both MALS Postural orthostatic Tachycardia Syndrome POTS
3 POTS or other Dysautonomia symptoms bowel dysmotility
Study Population Subgroup of PPP
1 MALS patients with little or no improvement after laparoscopic arcuate ligament release
2 MALS POTS patients with little or no improvement after laparoscopic arcuate ligament release
3 POTSDysautonomia patients with bowel dysmotility Symptoms Required Chronic nausea food intolerance abdominal pain Additional Chronic vomiting need for enteral or parenteral Nutrition hyperhidrosis complex regional pain syndrome Raynauds Exclusion Criteria Evidence for non-dysautonomia related causes of the patients symptoms
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None