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AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Wilson Salgado Jr, MD, PhD contact

+5516981564846

wsalgado@fmrp.usp.br

Ana BT Soares, MD contact

+5516981188439

ana.beatriz.soares@alumni.usp.br

Brazil1 site

  • Hospital das Clínicas de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14048900

    Fabiana CP Valera, MD PhD, +5516981548312, facpvalera@fmrp.usp.br

Other trials in Brazil

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.

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 groups in NCT07728682
Study groupRoleWhat they receive
Transit Bipartition After Sleeve GastrectomyExperimentalParticipants 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.

  1. 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)

  1. 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

  2. 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

  3. Change in Esophageal Acid Exposure

    Change in percentage of monitoring time with esophageal pH below 4.

    Measured: Baseline to 6 months

  4. Route-Specific Gastric Transit

    Scintigraphic distribution of the solid meal through pyloric/duodenal and gastroileal routes

    Measured: 6 months

  5. 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

  6. Change in Glycemic Measures

    Change in fasting glucose, HbA1c

    Measured: Baseline to 6 months

  7. Change in Fecal Elastase

    Change in fecal elastase concentration

    Measured: Baseline to 6 months

  8. 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.

  1. First posted27 Jul 2026
  2. Study start2 Aug 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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.

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?

On the ClinicalTrials.gov record for NCT07728682.

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.

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