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

NCT ID: NCT03706846

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2018-08-27

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).

Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fasting 2 hours

Fasting 2 hours

Group Type OTHER

fasting

Intervention Type PROCEDURE

fasting before gastrointestinal endoscopy

Fasting 6 hours

Fasting 6 hours

Group Type OTHER

fasting

Intervention Type PROCEDURE

fasting before gastrointestinal endoscopy

Interventions

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fasting

fasting before gastrointestinal endoscopy

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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P/2017/343

Identifier Type: -

Identifier Source: org_study_id

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