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

Cirrhosis Clinical Trial

— GAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306963
• Other study ID #: 23-004669
• Status: Recruiting
• Start date: March 22, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Taylor N Hines
• Phone: 507-538-9959
• Email: hines.taylor[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Gastric Antral Vascular Ectasia

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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