Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.

The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Reflux, Gastroesophageal; Bariatric Surgery; Severe Obesity
• Intervention / Treatment: Procedure: Endoscopic SASI

Detailed Description

The current standard of care for patients who experience insufficient weight loss, weight re-gain or Type II diabetes relapse after a sleeve gastrectomy is a revisional laparoscopic sleeve gastrectomy.

However, such revisional procedure is commonly associated with high mortality and morbidity due to protein malnutrition. A noval bariatric procedure, single anastomosis sleeve ileal (SASI) bypass has emerged recently.

In this study, we are utilizing an incisionless novel endoscopic technique to efficiently replicate the anatomical features and physiological effects of SASI.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin Hong Lim, MD; Phone Number: 62223322; Email: lim.chin.hong@singhealth.com.sg
• Study Contact Backup: Name: Wei Min Chong, MSc; Email: chong.wei.min@sgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore General Hospital
    • Contact: Chin Hong Lim, MD; Phone Number: +65 62223322; Email: lim.chin.hong@singhealth.com.sg
    • Contact: Wei Min Chong, MSc
    • Contact: Chin Hong Lim, MD
  • Singapore, Singapore
    • Recruiting
    • Changi General Hospital
    • Contact: Jinlin Lin, MD; Phone Number: +6567888833; Email: lin.jinlin@singhealth.com.sg
    • Contact: Jinlin Lin, MD
  • Singapore, Singapore
    • Recruiting
    • Sengkang General Hospital
    • Contact: Baldwin Po Man Yeung, MD; Phone Number: +6569305000; Email: baldwin.yeung.p.m@singhealth.com.sg
    • Contact: Baldwin Po Man Yeung, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Subject must meet all the inclusion criteria to participate in this study and list each criterion.

1. Age: 21-65 years
2. Patients going for LSG at participating hospitals.
3. Able to provide informed consent

Individuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk.

Exclusion Criteria:

1. Patients who were breast feeding or pregnant
2. Severe psychiatric illness
3. Eating disorder
4. Active neoplastic disease
5. End-stage renal disease
6. Patients with bleeding diathesis
7. Patients with pacemakers or implantable cardiac defibrillators
8. Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
9. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
10. Treatment with anti-platelet agents that could not be temporarily discontinued

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: Intervention; Endoscopic SASI	Procedure: Endoscopic SASI; Endoscopic conversion to sleeve gastrectomy to SASI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of weight loss	Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c levels will be measured and reported in percentage (%)	6 months
GERD symptoms	Quality of Life in Reflux And Dyspepsia (QoLRAD) is a questionnaire used to assess how gastroesophageal reflux disease (GERD) and dyspepsia (indigestion) affects a person's quality of life. The total score will be calculated from the questionnaire and a reduction in QoLRAD score over time will demonstrate improvement.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility & Safety	Technical success rate & procedure related complications. Number of adverse events will be recorded at all times to determine the feasibility and safety of the study procedure.	30 days

Collaborators and Investigators

• Sponsor: Singapore Health Services
• Collaborators: Changi General Hospital; Sengkang General Hospital
• Investigators: Principal Investigator: Chin Hong Lim, MD, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Bariatric Surgery; SASI; Severe Obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Digestive System Diseases; Gastrointestinal Diseases; Glucose Metabolism Disorders; Esophageal Diseases; Insulin Resistance; Hyperinsulinism; Overweight; Obesity; Esophageal Motility Disorders; Deglutition Disorders; Metabolic Syndrome; Obesity, Morbid; Gastroesophageal Reflux
• Other Study ID Numbers: 2024-3067

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No