Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2014 |
| End Date: | June 2015 |
| Contact: | Irene Sonu, MD |
| Email: | isonu@stanford.edu |
| Phone: | 7034074899 |
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.
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.
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.
(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.
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).
We found this trial at
1
site
Click here to add this to my saved trials
