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

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Cirrhosis

Treatments

Procedure: fasting

Study type

Interventional

Funder types

Other

Identifiers

NCT03706846
P/2017/343

Details and patient eligibility

About

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).

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Fasting 2 hours
Other group
Description:
Fasting 2 hours
Treatment:
Procedure: fasting
Fasting 6 hours
Other group
Description:
Fasting 6 hours
Treatment:
Procedure: fasting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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