Clinical trial NCT02420925: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroparesis
Keywords: Gastroparesis
Celiac Plexus Block
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2015-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Increased gastric emptying
timeFrame: One week after intervention
measure: Improvement of gastroparesis based on GCSI-DD score
timeFrame: 2 months
Secondary outcomes:
measure: Improvement of individual symptoms related to gastroparesis based on VAS score
timeFrame: 1week-2 months after procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Linda Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Irene Sonu, MD
role: STUDY_DIRECTOR
References:
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.