Transit Bipartition After Sleeve Gastrectomy (BTT-SLEEVE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bariatric Surgery; Obesity & Overweight; Gastroesophageal Reflux (GERD); Weight Recurrence
• Intervention / Treatment: Procedure: Conversion to Intestinal Transit Bipartition

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wilson Salgado Jr, MD, PhD; Phone Number: +5516981564846; Email: wsalgado@fmrp.usp.br
• Study Contact Backup: Name: Ana BT Soares, MD; Phone Number: +5516981188439; Email: ana.beatriz.soares@alumni.usp.br

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048900
      • Hospital das Clinicas de Ribeirao Preto
      • Contact: Fabiana CP Valera, MD PhD; Phone Number: +5516981548312; Email: facpvalera@fmrp.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transit Bipartition After Sleeve Gastrectomy; Participants with previous sleeve gastrectomy undergo revisional conversion to intestinal transit bipartition and are followed for 12 months.	Procedure: Conversion to Intestinal Transit Bipartition; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months after transit bipartition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GERD-HRQL Score	Change in total validated Gastroesophageal Reflux Disease Health-Related Quality of Life score.	Baseline to 6 months
Change in DeMeester Score	Change in the composite DeMeester score derived from 24-hour esophageal pH monitoring.	Baseline to 6 months
Change in Esophageal Acid Exposure	Change in percentage of monitoring time with esophageal pH below 4.	Baseline to 6 months
Route-Specific Gastric Transit	Scintigraphic distribution of the solid meal through pyloric/duodenal and gastroileal routes	6 months
Change in GLP-1 AUC	Change in postprandial hormone area under the concentration-time curve from 0 to 180 minutes.	Baseline to 6 months
Change in Glycemic Measures	Change in fasting glucose, HbA1c	Baseline to 6 months
Change in Fecal Elastase	Change in fecal elastase concentration	Baseline to 6 months
Change in Body Weight	Change in measured body weight at each scheduled postoperative visit.	Baseline; 3, 6, 9, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroileal Anastomotic Caliber	Endoscopically measured mature diameter and patency of the gastroileal anastomosis	12 months
Adverse Events and Complications	Incidence and description of surgery-related, examination-related, and follow-up adverse events and complications.	Procedure through 12 months

Collaborators and Investigators

• Sponsor: Hospital das Clínicas de Ribeirão Preto
• Investigators: Principal Investigator: Wilson Salgado Jr, MD PhD, Hospital Estadual de Ribeirão Preto

Study record dates

Study Major Dates

• Study Start (Estimated): August 2, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; gastric emptying; sleeve gastrectomy; DeMeester score; fecal elastase; transit bipartition; scintyigraphy; T1/2; gastroileal anastomosis
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Gastroesophageal Reflux
• Other Study ID Numbers: HCRP-BTT-2026-01; CAAE 95147126.1.0000.5440 (Other Identifier: Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No