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

NCT03706846 | Completed

• 1 other identifier: P/2017/343
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Cirrhosis

Keywords

Cirrhosis; Upper digestive endoscopy; fasting; esophageal cancer; Superficial neoplastic lesions; Esophageal mucosa; Gastric mucosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Questionnaire concerning security

  During endoscopy

• Questionnaire concerning patient confort during fasting

  The day of the endoscopy

Study Arms (2)

Fasting 2 hours

OTHER

Fasting 2 hours

Procedure: fasting

Fasting 6 hours

OTHER

Fasting 6 hours

Procedure: fasting

Interventions

fasting PROCEDURE

fasting before gastrointestinal endoscopy

Fasting 2 hours; Fasting 6 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years,
• Male or female
• Cirrhosis based on radiological, clinical, biological or histological criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire

Besançon, 25000, France

Location

MeSH Terms

Conditions

Fibrosis; Fasting; Esophageal Neoplasms

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 16, 2018
• Study Start: April 18, 2018
• Primary Completion: August 27, 2018
• Study Completion: August 27, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)