Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis

NCT02420925 | Withdrawn

• 1 other identifier: celblockgastro
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

Gastroparesis; Celiac Plexus Block

Outcome Measures

Primary Outcomes (2)

• Increased gastric emptying

  We will assess for increased gastric emptying via a SmartPill study, one week after celiac plexus block is performed.

  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).

  2 months

Secondary Outcomes (1)

• Improvement of individual symptoms related to gastroparesis based on VAS score

  1week-2 months after procedure

Study Arms (1)

Celiac Plexus Block

EXPERIMENTAL

There is one treatment arm who undergoes celiac plexus block.

Procedure: Celiac Plexus Block

Interventions

Celiac Plexus Block PROCEDURE

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.

Celiac Plexus Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Linda Nguyen: lead
• Stanford University: collaborator

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 20103540 BACKGROUND

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda Nguyen, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Irene Sonu, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

US (1)