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

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis; Gastric Antral Vascular Ectasia
• Intervention / Treatment: Diagnostic test: Gastric Emptying

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Taylor N Hines; Phone Number: 507-538-9959; Email: hines.taylor@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Taylor N Hines; Phone Number: 507-538-9959; Email: hines.taylor@mayo.edu
      • Contact: Anjali Rajagopal, MBBS; Phone Number: 507-266-8779; Email: Rajagopal.Anjali@mayo.edu
      • Principal Investigator: Xiao Jing Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have undergone an endoscopy and found to have GAVE will be included. Patients with underlying cirrhosis and GAVE in comparison to control patients with cirrhosis and no GAVE.

Description

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 active bleeding.
• Patients with severe decompensated liver disease.
• Patients with chronic kidney disease.
• Presence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
• Pregnant or lactating women due to radiation exposure.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cirrhosis With Gastric Antral Vascular Ectasia; 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.	Diagnostic test: Gastric Emptying; Measured by radioscintigraphy after overnight fast using a radiolabeled meal consisting of two 99mTc - labeled scrambled eggs, one slice of whole wheat bread and one glass of 111In DTPA skim milk (320kcal, 30% fat). A variable region of interest program will be used to quantitate counts in the stomach. Data will be summarized as GE T1/2 and GE % emptied at 1, 2 and 4 hours. To assess gastric emptying, the protocol meal as described above will be given. Anterior and posterior scans of the abdomen, each of two minutes duration, will be obtained right after the meal is ingested to ensure adequate acquisition of counts. Scans will then be done at time 0 subsequently in 15-minute intervals to 90 minutes, then in 30-minute intervals thereafter to 240 minutes supine.; Other Names: Gastric motor function testing
Cirrhosis Without Gastric Antral Vascular Ectasia; 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.	Diagnostic test: Gastric Emptying; Measured by radioscintigraphy after overnight fast using a radiolabeled meal consisting of two 99mTc - labeled scrambled eggs, one slice of whole wheat bread and one glass of 111In DTPA skim milk (320kcal, 30% fat). A variable region of interest program will be used to quantitate counts in the stomach. Data will be summarized as GE T1/2 and GE % emptied at 1, 2 and 4 hours. To assess gastric emptying, the protocol meal as described above will be given. Anterior and posterior scans of the abdomen, each of two minutes duration, will be obtained right after the meal is ingested to ensure adequate acquisition of counts. Scans will then be done at time 0 subsequently in 15-minute intervals to 90 minutes, then in 30-minute intervals thereafter to 240 minutes supine.; Other Names: Gastric motor function testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abridged Bowel Disease Questionnaire	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.	baseline
Nepean Dyspepsia Index	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.	baseline
Leuven Postprandial Distress Scale	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Emptying Half Time (T 1/2) of Solids	Subjects will ingest a radio labeled meal consisting of two 99mTc. Anterior and posterior scans of the abdomen, each of two minutes duration, will be obtained right after the meal is ingested to ensure adequate acquisition of counts.	1 hour, 2 hours, 4 hours
Gastric Emptying Half Time (T 1/2) of liquids	Subjects will ingest one glass of 111In DTPA skim milk. Anterior and posterior scans of the abdomen, each of two minutes duration, will be obtained right after the meal is ingested to ensure adequate acquisition of counts.	1 hour, 2 hours, 4 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Xiao Jing Wang, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathological Conditions, Anatomical; Angiodysplasia; Dilatation, Pathologic; Gastric Antral Vascular Ectasia
• Other Study ID Numbers: 23-004669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No