Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
Primary Purpose
Gastroparesis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Celiac Plexus Block
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Celiac Plexus Block
Eligibility Criteria
Inclusion Criteria:
- Patients must have gastroparesis due to idiopathic causes (including post-viral) and diabetes who have undergone a 4 hour gastric emptying study showing delayed gastric emptying
- Patients may have been or currently on therapy for their gastroparesis including metoclopramide, domperidone, macrolide antibiotics, sapropterin dihydrochloride, or pyloric botox injections can be included
- Patients who have undergone placement of electrical gastric stimulator >6 months after enrollment can be included
Exclusion Criteria:
- Patients with suspected mechanical obstruction resulting in delayed gastric emptying, patients chronically using narcotics (>3 times per week)
- Patients who have undergone placement of gastric electrical stimulation device within 6 months of enrollment.
- Patients with any history of small bowel obstruction and major abdominal surgeries (excluding appendectomy, cholecystectomy, Nissen fundoplication, or pelvic surgeries).
Sites / Locations
- Stanford Hospital and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Celiac Plexus Block
Arm Description
There is one treatment arm who undergoes celiac plexus block.
Outcomes
Primary Outcome Measures
Increased gastric emptying
We will assess for increased gastric emptying via a SmartPill study, one week after celiac plexus block is performed.
Improvement of gastroparesis based on GCSI-DD score
One, two, three weeks after the procedure as well as 2 months after the celiac plexus block, the patients will fill out a questionnaire questionnaire comprised of the gastroparesis cardinal symptom index daily diary(GCSI-DD).
Secondary Outcome Measures
Improvement of individual symptoms related to gastroparesis based on VAS score
One, two, and three weeks after the celiac plexus block as well as 2 months after the procedure, the patients will fill out a VAS questionnaire to assess their symptoms related to their gastroparesis.
Full Information
NCT ID
NCT02420925
First Posted
April 15, 2015
Last Updated
August 26, 2020
Sponsor
Linda Nguyen
Collaborators
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT02420925
Brief Title
Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
Official Title
Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
enrollment "0"
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Linda Nguyen
Collaborators
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that in patients with gastroparesis, gastric emptying will improve with celiac plexus block. By improving gastric emptying, symptoms related to gastroparesis including nausea, vomiting, bloating, abdominal pain, and weight loss, will also improve.
In order to study this hypothesis, the investigators will enroll patients with gastroparesis who are non-responsive to the current treatments available. Patients will fill out a questionnaire to assess the severity of their symptoms then undergo Ansar testing (a non-invasive test) to measure their autonomic function respectively. Then, patients will undergo a celiac plexus block which is performed via an upper endoscopy. One week after the procedure, patients will be asked to undergo a gastric emptying study as well as repeat the Ansar testing to evaluate for any improvement in the gastric emptying and autonomic function respectively. Patient will be asked to repeat the questionnaire, one, two, three, and eight weeks after their procedure.
Detailed Description
The investigators will identify patients with gastroparesis due to idiopathic causes (including post-viral) and diabetes who have undergone a 4 hour gastric emptying study showing delayed gastric emptying. Patients enrolled must have clinical symptoms due to gastroparesis including nausea, vomiting, abdominal pain, early satiety, bloating, reflux, postprandial fullness or weight loss. Patients included in the study may be refractory to treatment or ineligible for current standard of care with metoclopramide, domperidone, macrolide antibiotics, or pyloric injections with botulinum toxin.
Patients who agree to enroll in the study will sign an informed consent which will explain study purpose along with the risks of the procedures involved in the study. One of the team members will also explain the study to the patient either over the phone or in person and answer any questions they may have in regards to the study.
Patients who are enrolled in the study will fill out a questionnaire comprised of the gastroparesis cardinal symptom index daily diary (GCSI-DD) and visual analog scale (VAS) to assess severity of nausea, vomiting, abdominal pain, and bloating. Then, patients will undergo autonomic function measurements using the Ansar system which is a non-invasive measurement of the autonomic system using blood pressure, heart rate, and respiratory rate monitoring. Ansar testing takes approximately 15 minutes.
Subsequently, patients will undergo a celiac plexus block, performed endoscopically with EUS- guidance by Ann Chen. Injections will be performed using 0.75% bupivicaine and 40mg/ml of triamcinolone, ideally 1ml each directly into the celiac ganglia. If no ganglia is identifiable, then the injection will be performed into the celiac space, located at the take off of the celiac artery from the aorta. One week after their block, a gastric emptying study and Ansar testing will be performed. The GCSI-DD/VAS questionnaire will be repeated 1 week, 2 weeks, 3 weeks, and 2 months after the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroparesis, Celiac Plexus Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Celiac Plexus Block
Arm Type
Experimental
Arm Description
There is one treatment arm who undergoes celiac plexus block.
Intervention Type
Procedure
Intervention Name(s)
Celiac Plexus Block
Intervention Description
Patients will undergo celiac plexus block via upper endoscopy with endoscopic ultrasound guidance. Injections will be performed using 0.75% bupivicaine and 40mg/ml of triamcinolone, ideally 1ml each directly into the celiac ganglia. If no ganglia is identifiable, then the injection will be performed into the celiac space, located at the take off of the celiac artery from the aorta.
Primary Outcome Measure Information:
Title
Increased gastric emptying
Description
We will assess for increased gastric emptying via a SmartPill study, one week after celiac plexus block is performed.
Time Frame
One week after intervention
Title
Improvement of gastroparesis based on GCSI-DD score
Description
One, two, three weeks after the procedure as well as 2 months after the celiac plexus block, the patients will fill out a questionnaire questionnaire comprised of the gastroparesis cardinal symptom index daily diary(GCSI-DD).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improvement of individual symptoms related to gastroparesis based on VAS score
Description
One, two, and three weeks after the celiac plexus block as well as 2 months after the procedure, the patients will fill out a VAS questionnaire to assess their symptoms related to their gastroparesis.
Time Frame
1week-2 months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have gastroparesis due to idiopathic causes (including post-viral) and diabetes who have undergone a 4 hour gastric emptying study showing delayed gastric emptying
Patients may have been or currently on therapy for their gastroparesis including metoclopramide, domperidone, macrolide antibiotics, sapropterin dihydrochloride, or pyloric botox injections can be included
Patients who have undergone placement of electrical gastric stimulator >6 months after enrollment can be included
Exclusion Criteria:
Patients with suspected mechanical obstruction resulting in delayed gastric emptying, patients chronically using narcotics (>3 times per week)
Patients who have undergone placement of gastric electrical stimulation device within 6 months of enrollment.
Patients with any history of small bowel obstruction and major abdominal surgeries (excluding appendectomy, cholecystectomy, Nissen fundoplication, or pelvic surgeries).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Nguyen, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irene Sonu, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20103540
Citation
Memis D, Inal MT, Temizoz O, Genchallac H, Ozdemir H, Sut N. The effect of celiac plexus block in critically ill patients intolerant of enteral nutrition: a randomized, placebo-controlled study. Anesth Analg. 2010 Apr 1;110(4):1071-5. doi: 10.1213/ANE.0b013e3181cde870. Epub 2010 Jan 26.
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Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
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