GastroparesisNCT02420925
Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
A study testing Celiac Plexus Block in people with Gastroparesis, run by Linda Nguyen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Celiac Plexus Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Gastroparesis
- Being tested
- Celiac Plexus Block
- Keywords
- Gastroparesis, Celiac Plexus Block
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celiac Plexus BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Plexus Block | Experimental | There is one treatment arm who undergoes celiac plexus block. Receives: Procedure: Celiac Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased gastric emptying
We will assess for increased gastric emptying via a SmartPill study, one week after celiac plexus block is performed.
Measured: One week after intervention
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).
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 1week-2 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: enrollment "0"
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linda Nguyen
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor-investigator, Linda Nguyen, Stanford University
- Investigators
- Linda Nguyen, MD, Principal investigator, Stanford UniversityIrene Sonu, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420925
- Sponsor's protocol ID
- celblockgastro
- Status last verified
- Aug 2020
- First submitted
- 15 Apr 2015
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20103540
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
- ClinicalTrials.gov ID
- NCT02420925
- Acronym / sponsor ID
- celblockgastro
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Celiac Plexus Block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: enrollment "0"
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Linda NguyenUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celiac Plexus Block | Experimental | Procedure: Celiac Plexus BlockThere is one treatment arm who undergoes celiac plexus block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celiac Plexus BlockPatients 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. | Procedure or surgery | Celiac Plexus Block |
Primary outcome
Increased gastric emptying
Time frame: One week after intervention
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
Time frame: 2 months
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).
1 secondary outcome
Improvement of individual symptoms related to gastroparesis based on VAS score
Time frame: 1week-2 months after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Background: PubMed 20103540Memis 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Nguyen, MD principal investigator
Stanford University
Irene Sonu, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celiac Plexus Block in people with Gastroparesis, run by Linda Nguyen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased gastric emptying (time frame: One week after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.