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

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).

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Key information

Conditions

Cirrhosis Behavior Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Fasting Feeding Behavior Fibrosis Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting

Procedure

fasting before gastrointestinal endoscopy

Primary outcomes

Score for quality of visualization of the esophageal and gastric mucosa

Time frame: 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 outcomes

Questionnaire concerning security

Time frame: During endoscopy

Questionnaire filled by the investigator concerning the side effectets observed or not observed
Questionnaire concerning patient confort during fasting

Time frame: The day of the endoscopy

Snsations felt or not felt by the patients

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: GASTROPREP

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Oct 16, 2018
Registry last updated: Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed