Cirrhosis
Conditions
Keywords
Cirrhosis, Upper digestive endoscopy, fasting, esophageal cancer, Superficial neoplastic lesions, Esophageal mucosa, Gastric mucosa
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).
Interventions
PROCEDUREfasting
fasting before gastrointestinal endoscopy
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed