CirrhosisGASTROPREPNCT03706846
Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids
A study testing fasting in people with Cirrhosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- fasting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2018to 27 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years,
- Male or female
- Cirrhosis based on radiological, clinical, biological or histological criteria
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- fasting
- Keywords
- Cirrhosis, Upper digestive endoscopy, fasting, esophageal cancer, Superficial neoplastic lesions, Esophageal mucosa, Gastric mucosa
- Medical subject headings
- Fibrosis, Fasting, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fastingProcedure or surgery
fasting before gastrointestinal endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fasting 2 hours | Other | Fasting 2 hours Receives: Procedure: fasting |
| Fasting 6 hours | Other | Fasting 6 hours Receives: Procedure: fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During endoscopy
Secondary outcomes (2)
Questionnaire concerning security
Questionnaire filled by the investigator concerning the side effectets observed or not observed
Measured: During endoscopy
Questionnaire concerning patient confort during fasting
Snsations felt or not felt by the patients
Measured: The day of the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start18 Apr 2018
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706846
- Sponsor's protocol ID
- P/2017/343
- Acronym
- GASTROPREP
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids
- ClinicalTrials.gov ID
- NCT03706846
- Acronym / sponsor ID
- GASTROPREP / P/2017/343
- Conditions
- Cirrhosis
- Keywords
- Cirrhosis, Upper digestive endoscopy, fasting, esophageal cancer, Superficial neoplastic lesions, Esophageal mucosa, Gastric mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting 2 hours | Other | Procedure: fastingFasting 2 hours |
| Fasting 6 hours | Other | Procedure: fastingFasting 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years,
- Male or female
- Cirrhosis based on radiological, clinical, biological or histological criteria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fastingfasting before gastrointestinal endoscopy | Procedure or surgery | Fasting 2 hours, Fasting 6 hours |
Primary outcome
Score for quality of visualization of the esophageal and gastric mucosa
Time frame: During endoscopy
The score is graded from A (good quality) to C (poor quality) according to a score developed by Elvas et al. (Endoscopy 2017).
2 secondary outcomes
Questionnaire concerning security
Time frame: During endoscopy
Questionnaire concerning patient confort during fasting
Time frame: The day of the endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fasting in people with Cirrhosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score for quality of visualization of the esophageal and gastric mucosa (time frame: During endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.