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NCT Number: NCT07728682

Transit Bipartition After Sleeve Gastrectomy

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.

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Key information

Conditions

Obesity & Overweight Bariatric Surgery Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux (GERD) Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048900, Brazil

Location contact

Fabiana CP Valera, MD PhD

CONTACT

[email protected]

+5516981548312

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Liver cirrhosis;
  • Absence of willingness to undergo a new surgical procedure.

Treatment and study plan

Conversion to Intestinal Transit Bipartition

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in GERD-HRQL Score

    Time frame: Baseline to 6 months

    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.

  2. Change in DeMeester Score

    Time frame: Baseline to 6 months

    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.

  3. Change in Esophageal Acid Exposure

    Time frame: Baseline to 6 months

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

  4. Route-Specific Gastric Transit

    Time frame: 6 months

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

  5. Change in GLP-1 AUC

    Time frame: Baseline to 6 months

    Change in postprandial hormone area under the concentration-time curve from 0 to 180 minutes.

  6. Change in Glycemic Measures

    Time frame: Baseline to 6 months

    Change in fasting glucose, HbA1c

  7. Change in Fecal Elastase

    Time frame: Baseline to 6 months

    Change in fecal elastase concentration

  8. Change in Body Weight

    Time frame: Baseline; 3, 6, 9, and 12 months

    Change in measured body weight at each scheduled postoperative visit.

Other outcomes

  1. Gastroileal Anastomotic Caliber

    Time frame: 12 months

    Endoscopically measured mature diameter and patency of the gastroileal anastomosis

  2. Adverse Events and Complications

    Time frame: Procedure through 12 months

    Incidence and description of surgery-related, examination-related, and follow-up adverse events and complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana BT Soares, MD

CONTACT

[email protected]

+5516981188439

Wilson Salgado Jr, MD, PhD

CONTACT

[email protected]

+5516981564846

Sponsors and collaborators

Lead sponsor

Hospital das Clínicas de Ribeirão Preto

Other

Registry information

Official study title

Clinical, Metabolic, and Physiological Evaluation of Conversion From Sleeve Gastrectomy to Intestinal Transit Bipartition

Acronym: BTT-SLEEVE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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