Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Procedure: fasting

• Registration Number: NCT03706846
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

Upper gastrointestinal endoscopy is the key examination for screening for precancerous and cancerous lesions of the esophagus and stomach. This study aims to describe the quality of the visualization of the esophageal and gastric mucosa, the safety of use of two fasting procedures before gastroscopy and the feeling of patients. The population evaluated here concerns cirrhotic patients, at high risk of developing a precancerous lesion of the upper gastrointestinal tract.

The investigator carries out a prospective, monocentric (Besançon CHRU), interventional and randomized study according to two fasting procedures before gastroscopy: 6 hours (F6 group) versus 2 hours (F2 group) for clear fluids. The primary endpoint was to describe and compare the quality of visualization of the esophageal and gastric mucosa, graded from A (good quality) to C (poor quality) according to a score. developed by Elvas et al. (Endoscopy 2017).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-18
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-27
• Status Verified: 2018-10
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-15
• Last Update Submitted: 2018-10-15
• Study First Posted: 2018-10-16
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age > 18 years,
• Male or female
• Cirrhosis based on radiological, clinical, biological or histological criteria

Exclusion Criteria

• Diabetes for more than 10 years;
• Under 18 years of age;
• History of inhalation
• Patients in whom the gastrointestinal anatomy has not been retained
• Subjects who were unlikely to cooperate with the study and / or in whom poor cooperation was anticipated by the investigator
• Pregnant women Patients taking drugs that may slow down gastric Emptying such as: anticholinergic drugs, phenothiazines, antidepressants History of esophageal radiotherapy Unsubstituted hypothyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting 2 hours	fasting	Fasting 2 hours
Fasting 6 hours	fasting	Fasting 6 hours

Primary Outcome Measures

Name	Time	Method
Score for quality of visualization of the esophageal and gastric mucosa	During endoscopy	The score is graded from A (good quality) to C (poor quality) according to a score developed by Elvas et al. (Endoscopy 2017).

Secondary Outcome Measures

Name	Time	Method
Questionnaire concerning security	During endoscopy	Questionnaire filled by the investigator concerning the side effectets observed or not observed
Questionnaire concerning patient confort during fasting	The day of the endoscopy	Snsations felt or not felt by the patients

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Besançon, France