Obesity & OverweightBTT-SLEEVENCT07728682
Transit Bipartition After Sleeve Gastrectomy
A study testing Conversion to Intestinal Transit Bipartition in people with Obesity & Overweight and Gastroesophageal Reflux (GERD), run by Hospital das Clínicas de Ribeirão Preto at 1 site in Brazil.
Trial summary
This prospective, single-center study will evaluate adults undergoing revisional conversion from sleeve gastrectomy to intestinal transit bipartition. Forty participants will complete clinical, endoscopic, physiological, metabolic, hormonal, imaging, and stool assessments before surgery and during follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Gastroesophageal Reflux (GERD), Weight Recurrence
- What is being tested?
- Conversion to Intestinal Transit Bipartition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or older;
- Previous sleeve gastrectomy for the treatment of obesity;
- Follow-up at the HCRP gastrosurgery/bariatric surgery outpatient clinic through 2026;
- Clinical evaluation supporting revisional conversion to intestinal transit bipartition;
- Willingness to undergo the new surgical procedure and provide written informed consent.
Who cannot join
- Liver cirrhosis;
- Absence of willingness to undergo a new surgical procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048900
Fabiana CP Valera, MD PhD, +5516981548312, facpvalera@fmrp.usp.br
About this study
Official title: Clinical, Metabolic, and Physiological Evaluation of Conversion From Sleeve Gastrectomy to Intestinal Transit Bipartition
This prospective, single-center study will evaluate adults undergoing revisional conversion from sleeve gastrectomy to intestinal transit bipartition. Forty participants will complete clinical, endoscopic, physiological, metabolic, hormonal, imaging, and stool assessments before surgery and during follow-up. The primary outcome is the within-participant change in solid-meal gastric emptying half-time (T½), measured by standardized scintigraphy from baseline to 6 months. Secondary and exploratory outcomes include reflux symptoms, DeMeester score and acid exposure, route-specific gastric transit, GLP-1 and ghrelin responses, glucose metabolism, fecal elastase, gut microbiota, body-weight trajectory, comorbidities, gastroileal anastomotic caliber, and safety.
Read the detailed description
Patients previously undergoing sleeve gastrectomy and followed at the bariatric/gastrosurgery clinic of Hospital das Clínicas de Ribeirão Preto will be enrolled consecutively after informed consent. Baseline assessments include medical-record review, anthropometry, GERD-HRQL, upper gastrointestinal endoscopy, high-resolution esophageal manometry, 24-hour esophageal pH monitoring, CT gastric volumetry, solid-meal gastric emptying scintigraphy, metabolic and hormonal testing, and stool collection for microbiota and fecal elastase analyses. Transit bipartition will create a side-to-side gastroileal anastomosis and a distal side-to-side ileoileal anastomosis while preserving pyloric and duodenal transit. Selected paired assessments will be repeated at 6 months. Body weight and comorbidities will be followed at 3, 6, 9, and 12 months, and upper gastrointestinal endoscopy will be repeated at 12 months to assess the mature gastroileal anastomosis. The target of 40 participants is expected to provide 34 complete baseline and 6-month T½ pairs after allowance for 15% attrition.
- Conditions
- Obesity & Overweight, Gastroesophageal Reflux (GERD), Weight Recurrence, Bariatric Surgery
- Being tested
- Conversion to Intestinal Transit Bipartition
- Keywords
- sleeve gastrectomy, transit bipartition, gastric emptying, scintyigraphy, T1/2, DeMeester score, gastroileal anastomosis, GLP-1, fecal elastase
- Medical subject headings
- Obesity, Overweight, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion to Intestinal Transit BipartitionProcedure or surgery
Revisional surgery creating a side-to-side gastroileal anastomosis, planned at approximately 4 cm, and a distal side-to-side ileoileal anastomosis while preserving the pyloric and duodenal route. Surgery is planned laparoscopically; open conversion or additional gastric resection may be performed when clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Transit Bipartition After Sleeve Gastrectomy | Experimental | Participants with previous sleeve gastrectomy undergo revisional conversion to intestinal transit bipartition and are followed for 12 months. Receives: Procedure: Conversion to Intestinal Transit Bipartition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Solid-Meal Gastric Emptying Half-Time (T½)
Within-participant change in gastric emptying half-time, in minutes, measured by standardized solid-meal gastric emptying scintigraphy. The measure is calculated as the 6-month postoperative T½ minus the preoperative baseline T½.
Measured: Baseline to 6 months after transit bipartition
Secondary outcomes (8)
Change in GERD-HRQL Score
Change from baseline to 6 months in the total score of the validated Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Questionnaire. The questionnaire contains 10 symptom items, each scored from 0 (no symptoms) to 5 (incapacitating symptoms), yielding a total score ranging from 0 to 50. Higher total scores indicate more severe gastroesophageal reflux disease symptoms and worse health-related quality of life. Change will be calculated as the 6-month score minus the baseline score; negative values indicate improvement, whereas positive values indicate worsening. The separate patient satisfaction item (satisfied, neutral, or dissatisfied) is not included in the total score.
Measured: Baseline to 6 months
Change in DeMeester Score
Change from baseline to 6 months in the composite DeMeester score derived from 24-hour ambulatory esophageal pH monitoring. The score incorporates six parameters: percentage of total recording time with esophageal pH below 4, percentage of upright time with pH below 4, percentage of supine time with pH below 4, total number of reflux episodes, number of reflux episodes lasting longer than 5 minutes, and duration of the longest reflux episode. The DeMeester score is a continuous composite index with no predefined minimum or maximum value. Higher scores indicate greater pathological esophageal acid exposure and therefore a worse outcome. A score greater than 14.72 is conventionally considered abnormal. Change will be calculated as the 6-month score minus the baseline score; negative values indicate improvement, whereas positive values indicate worsening.
Measured: Baseline to 6 months
Change in Esophageal Acid Exposure
Change in percentage of monitoring time with esophageal pH below 4.
Measured: Baseline to 6 months
Route-Specific Gastric Transit
Scintigraphic distribution of the solid meal through pyloric/duodenal and gastroileal routes
Measured: 6 months
Change in GLP-1 AUC
Change in postprandial hormone area under the concentration-time curve from 0 to 180 minutes.
Measured: Baseline to 6 months
Change in Glycemic Measures
Change in fasting glucose, HbA1c
Measured: Baseline to 6 months
Change in Fecal Elastase
Change in fecal elastase concentration
Measured: Baseline to 6 months
Change in Body Weight
Change in measured body weight at each scheduled postoperative visit.
Measured: Baseline; 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start2 Aug 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants undergo revisional conversion from sleeve gastrectomy to intestinal transit bipartition and are assessed before and after surgery.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital das Clínicas de Ribeirão Preto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilson Salgado Jr, MD PhD, Principal investigator, Hospital Estadual de Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728682
- Sponsor's protocol ID
- HCRP-BTT-2026-01
- Other IDs
- CAAE 95147126.1.0000.5440
- Acronym
- BTT-SLEEVE
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No public individual participant data sharing is planned because the dataset contains sensitive clinical, physiological, imaging, and biological information from a small single-center cohort. Aggregate and deidentified results will be reported in scientific publications and ClinicalTrials.gov results when applicable.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Metabolic, and Physiological Evaluation of Conversion From Sleeve Gastrectomy to Intestinal Transit Bipartition
- ClinicalTrials.gov ID
- NCT07728682
- Acronym / sponsor ID
- BTT-SLEEVE / HCRP-BTT-2026-01
- Conditions
- Obesity & Overweight, Gastroesophageal Reflux (GERD), Weight Recurrence, Bariatric Surgery
- Keywords
- sleeve gastrectomy, transit bipartition, gastric emptying, scintyigraphy, T1/2, DeMeester score, gastroileal anastomosis, GLP-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital das Clínicas de Ribeirão PretoUniversity, hospital or other
- Study start
- 2 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Jul 2026 (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.
This prospective, single-center study will evaluate adults undergoing revisional conversion from sleeve gastrectomy to intestinal transit bipartition. Forty participants will complete clinical, endoscopic, physiological, metabolic, hormonal, imaging, and stool assessments before surgery and during follow-up. The primary outcome is the within-participant change in solid-meal gastric emptying half-time (T½), measured by standardized scintigraphy from baseline to 6 months. Secondary and exploratory outcomes include reflux symptoms, DeMeester score and acid exposure, route-specific gastric transit, GLP-1 and ghrelin responses, glucose metabolism, fecal elastase, gut microbiota, body-weight trajectory, comorbidities, gastroileal anastomotic caliber, and safety.
Detailed description
Patients previously undergoing sleeve gastrectomy and followed at the bariatric/gastrosurgery clinic of Hospital das Clínicas de Ribeirão Preto will be enrolled consecutively after informed consent. Baseline assessments include medical-record review, anthropometry, GERD-HRQL, upper gastrointestinal endoscopy, high-resolution esophageal manometry, 24-hour esophageal pH monitoring, CT gastric volumetry, solid-meal gastric emptying scintigraphy, metabolic and hormonal testing, and stool collection for microbiota and fecal elastase analyses. Transit bipartition will create a side-to-side gastroileal anastomosis and a distal side-to-side ileoileal anastomosis while preserving pyloric and duodenal transit. Selected paired assessments will be repeated at 6 months. Body weight and comorbidities will be followed at 3, 6, 9, and 12 months, and upper gastrointestinal endoscopy will be repeated at 12 months to assess the mature gastroileal anastomosis. The target of 40 participants is expected to provide 34 complete baseline and 6-month T½ pairs after allowance for 15% attrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants undergo revisional conversion from sleeve gastrectomy to intestinal transit bipartition and are assessed before and after surgery.
| Arm | Type | Receives |
|---|---|---|
| Transit Bipartition After Sleeve Gastrectomy | Experimental | Procedure: Conversion to Intestinal Transit BipartitionParticipants with previous sleeve gastrectomy undergo revisional conversion to intestinal transit bipartition and are followed for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older;
- Previous sleeve gastrectomy for the treatment of obesity;
- Follow-up at the HCRP gastrosurgery/bariatric surgery outpatient clinic through 2026;
- Clinical evaluation supporting revisional conversion to intestinal transit bipartition;
- Willingness to undergo the new surgical procedure and provide written informed consent.
Key exclusion criteria (2 listed)
- Liver cirrhosis;
- Absence of willingness to undergo a new surgical procedure.
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 |
|---|---|---|
| Conversion to Intestinal Transit BipartitionRevisional surgery creating a side-to-side gastroileal anastomosis, planned at approximately 4 cm, and a distal side-to-side ileoileal anastomosis while preserving the pyloric and duodenal route. Surgery is planned laparoscopically; open conversion or additional gastric resection may be performed when clinically indicated. | Procedure or surgery | Transit Bipartition After Sleeve Gastrectomy |
Primary outcome
Change in Solid-Meal Gastric Emptying Half-Time (T½)
Time frame: Baseline to 6 months after transit bipartition
Within-participant change in gastric emptying half-time, in minutes, measured by standardized solid-meal gastric emptying scintigraphy. The measure is calculated as the 6-month postoperative T½ minus the preoperative baseline T½.
8 secondary outcomes
Change in GERD-HRQL Score
Time frame: Baseline to 6 months
Change in DeMeester Score
Time frame: Baseline to 6 months
Change in Esophageal Acid Exposure
Time frame: Baseline to 6 months
Route-Specific Gastric Transit
Time frame: 6 months
Change in GLP-1 AUC
Time frame: Baseline to 6 months
Change in Glycemic Measures
Time frame: Baseline to 6 months
Change in Fecal Elastase
Time frame: Baseline to 6 months
Change in Body Weight
Time frame: Baseline; 3, 6, 9, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. No public individual participant data sharing is planned because the dataset contains sensitive clinical, physiological, imaging, and biological information from a small single-center cohort. Aggregate and deidentified results will be reported in scientific publications and ClinicalTrials.gov results when applicable.
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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.
Wilson Salgado Jr, MD PhD principal investigator
Hospital Estadual de Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversion to Intestinal Transit Bipartition in people with Obesity & Overweight and Gastroesophageal Reflux (GERD), run by Hospital das Clínicas de Ribeirão Preto at 1 site in Brazil.
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 2 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: opening soon, as of the sponsor's last update on 3 Aug 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wilson Salgado Jr, MD, PhD (+5516981564846, wsalgado@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Solid-Meal Gastric Emptying Half-Time (T½) (time frame: Baseline to 6 months after transit bipartition). 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 3 Aug 2026.