Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Recruiting

• Conditions: Gastric Antral Vascular Ectasia; Cirrhosis; Chronic Kidney Disease
• Interventions: Diagnostic Test: Gastric Emptying

• Registration Number: NCT06306963
• Lead Sponsor: Mayo Clinic

Brief Summary

The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-12
• Study Start: 2024-03-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-03-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients >18 years of age with endoscopic evidence of Gastric Antral Vascular Ectasia.
• Willingness to participate in the study
• Capacity to provide informed consent.
• No evidence of organic, systemic, or metabolic disease (e.g. diabetes mellitus) to explain the symptoms on routine investigations

Exclusion Criteria

• Patients with transfusion dependent blood loss.
• Patients with severe decompensated liver disease.
• Patients with end stage renal disease.
• Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
• Pregnant or lactating women.
• Patients who have not had a CBC and differential blood draw completed within the last six months.
• Current heavy alcohol use.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis With Gastric Antral Vascular Ectasia	Gastric Emptying	Patients with Gastric Antral Vascular Ectasia with cirrhosis will undergo gastric motor function testing. This will be measured by radioscintigraphy after overnight fast using a radiolabeled meal.
Cirrhosis Without Gastric Antral Vascular Ectasia	Gastric Emptying	Patients without Gastric Antral Vascular Ectasia with cirrhosis will undergo gastric motor function testing. This will be measured by radioscintigraphy after overnight fast using a radiolabeled meal.

Primary Outcome Measures

Name	Time	Method
Nepean Dyspepsia Index	baseline	The Nepean Dyspepsia Index is a 10-item questionnaire that measures dyspepsia problems. Each item is scored from 1-5. 1 = Not at all, 5 = Extremely. Total scores range from 10 - 50, lower scores indicate less dyspepsia problems, higher scores indicate more dyspepsia problems.
Abridged Bowel Disease Questionnaire	baseline	The Abridged Bowel Disease Questionnaire is a 16-item questionnaire that measures Bowel Disease symptoms. Each item is scored as yes or no. Scores answering yes indicate more bowel disease, and scores answering no indicate less or no bowel disease.
Leuven Postprandial Distress Scale	baseline	The Leuven Postprandial Distress Scale is an 8-item questionnaire that measures symptoms of dyspepsia. Each item is scored from 1-5. 1 = Absent, 5 = very severe. Total scores range from 0-40 Lower scores indicate less or no symptoms of dyspepsia, higher scores indicate more symptoms of dyspepsia.

Secondary Outcome Measures

Name	Time	Method
GEBT Breath Test	6 Hours	The C-Spirulina Gastric Emptying Breath Test is a non-radioactive, Non-invasive test for measurement of the rate in gastric emptying in adults by measuring the C-13 levels in the breath.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States