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

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fasting
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cirrhosis focused on measuring Cirrhosis, Upper digestive endoscopy, fasting, esophageal cancer, Superficial neoplastic lesions, Esophageal mucosa, Gastric mucosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Fasting 2 hours

Fasting 6 hours

Arm Description

Fasting 2 hours

Fasting 6 hours

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Questionnaire concerning security
Questionnaire filled by the investigator concerning the side effectets observed or not observed
Questionnaire concerning patient confort during fasting
Snsations felt or not felt by the patients

Full Information

First Posted
October 9, 2018
Last Updated
October 15, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03706846
Brief Title
Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids
Acronym
GASTROPREP
Official Title
Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
Cirrhosis, Upper digestive endoscopy, fasting, esophageal cancer, Superficial neoplastic lesions, Esophageal mucosa, Gastric mucosa

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasting 2 hours
Arm Type
Other
Arm Description
Fasting 2 hours
Arm Title
Fasting 6 hours
Arm Type
Other
Arm Description
Fasting 6 hours
Intervention Type
Procedure
Intervention Name(s)
fasting
Intervention Description
fasting before gastrointestinal endoscopy
Primary Outcome Measure Information:
Title
Score for quality of visualization of the esophageal and gastric mucosa
Description
The score is graded from A (good quality) to C (poor quality) according to a score developed by Elvas et al. (Endoscopy 2017).
Time Frame
During endoscopy
Secondary Outcome Measure Information:
Title
Questionnaire concerning security
Description
Questionnaire filled by the investigator concerning the side effectets observed or not observed
Time Frame
During endoscopy
Title
Questionnaire concerning patient confort during fasting
Description
Snsations felt or not felt by the patients
Time Frame
The day of the endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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