Ulcer, GastricNCT04845438
Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
A study testing fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index in people with Ulcer, Gastric and Bile Reflux, run by Private Healthcare Institution Clinical Hospital RGD-Medicine at 1 site in Russia.
Trial summary
MGB is considered to be the best alternative to Roux-en-Y gastric bypass (RYGB) due to the shorter operation time and fewer possible complications. The purpose of this study was to determine biliary reflux in patients undergoing MGB/OAGB with a hand-sewn gastroenteroanastomosis, and MGB/OAGB with a stapler… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcer, Gastric, Bile Reflux
- What is being tested?
- fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteRussia
- Study dates
- 29 Dec 2020to 8 Mar 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- morbid obesity
- BMI above 35 kg/m2 with obesity related comorbidity
- BMI above 40 kg/m2
- undergoing MGB/OAGB
- no bile reflux during preoperative period
Who cannot join
- revisional operations
- therapy-resistant bile reflux during preoperative period
- history of bariatric surgery
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
Rostov-on-Don, 344010
Arut Mezhunts, 89885637263
About this study
MGB is considered to be the best alternative to Roux-en-Y gastric bypass (RYGB) due to the shorter operation time and fewer possible complications.
The purpose of this study was to determine biliary reflux in patients undergoing MGB/OAGB with a hand-sewn gastroenteroanastomosis, and MGB/OAGB with a stapler gastroenteroanastomosis.
- Conditions
- Ulcer, Gastric, Bile Reflux
- Being tested
- fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
- Medical subject headings
- Stomach Ulcer, Bile Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux IndexDiagnostic test
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
| Study group | Role | What they receive |
|---|---|---|
| hand-sewn gastroenteroanastomosis | Active comparator | Not described Receives: Diagnostic Test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index |
| stapler gastroenteroanastomosis | Active comparator | Not described Receives: Diagnostic Test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Determination of the BRI index in patients undergoing MGB/OAGB can be used as a screening method for diagnosing biliary reflux in order to prevent and develop tactic for further management of patients from a risk group of complications associated with the toxic effects of an aggressive bile
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start29 Dec 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion8 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer, GastricStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Private Healthcare Institution Clinical Hospital RGD-Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845438
- Sponsor's protocol ID
- CCH-RR-2020-mo-2
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
- ClinicalTrials.gov ID
- NCT04845438
- Acronym / sponsor ID
- CCH-RR-2020-mo-2
- Conditions
- Ulcer, Gastric, Bile Reflux
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Private Healthcare Institution Clinical Hospital RGD-MedicineUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 8 Mar 2022 (estimated)
- First posted
- 15 Apr 2021 (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.
MGB is considered to be the best alternative to Roux-en-Y gastric bypass (RYGB) due to the shorter operation time and fewer possible complications.
The purpose of this study was to determine biliary reflux in patients undergoing MGB/OAGB with a hand-sewn gastroenteroanastomosis, and MGB/OAGB with a stapler gastroenteroanastomosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hand-sewn gastroenteroanastomosis | Active comparator | Diagnostic Test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index |
| stapler gastroenteroanastomosis | Active comparator | Diagnostic Test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- morbid obesity
- BMI above 35 kg/m2 with obesity related comorbidity
- BMI above 40 kg/m2
- undergoing MGB/OAGB
- no bile reflux during preoperative period
Key exclusion criteria (3 listed)
- revisional operations
- therapy-resistant bile reflux during preoperative period
- history of bariatric surgery
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 |
|---|---|---|
| fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Indexfibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index | Diagnostic test | hand-sewn gastroenteroanastomosis, stapler gastroenteroanastomosis |
Primary outcome
Success
Time frame: 12 month
Determination of the BRI index in patients undergoing MGB/OAGB can be used as a screening method for diagnosing biliary reflux in order to prevent and develop tactic for further management of patients from a risk group of complications associated with the toxic effects of an aggressive bile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index in people with Ulcer, Gastric and Bile Reflux, run by Private Healthcare Institution Clinical Hospital RGD-Medicine at 1 site in Russia.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 2021. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arut Mezhunts (89885637263, arut.mezhunts@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: 12 month). 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 15 Apr 2021; AzTrials last refreshed its copy on 3 Nov 2026.