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

Cirrhosis Clinical Trial

— GASTROPREP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706846
• Other study ID #: P/2017/343
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: August 27, 2018

Study information

• Verified date: October 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

Procedure:
• fasting
fasting before gastrointestinal endoscopy

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Questionnaire concerning security	Questionnaire filled by the investigator concerning the side effectets observed or not observed	During endoscopy
Secondary	Questionnaire concerning patient confort during fasting	Snsations felt or not felt by the patients	The day of the endoscopy