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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cirrhosis

Intervention / Treatment
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* Procedure: fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fasting 2 hours<br>Fasting 2 hours | Procedure: fasting<br>* fasting before gastrointestinal endoscopy<br>|
| Other: Fasting 6 hours<br>Fasting 6 hours | Procedure: fasting<br>* fasting before gastrointestinal endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire concerning security | Questionnaire filled by the investigator concerning the side effectets observed or not observed | During endoscopy | 
| Questionnaire concerning patient confort during fasting | Snsations felt or not felt by the patients | The day of the endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Upper digestive endoscopy, fasting, esophageal cancer, Superficial neoplastic lesions, Esophageal mucosa, Gastric mucosa