RecruitingNCT07397624

Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer

Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer: a Prospective, Multicenter, Observational Study (ESG-ENDO)


Sponsor

Centro di Riferimento Oncologico - Aviano

Enrollment

74 participants

Start Date

Jan 8, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Obesity increases the risk of endometrial cancer, with higher Body Mass Index (BMI) leading to a significant increase in both cancer risk and recurrence. Because of the excellent cancer-specific outcomes and preponderance of obesity-related complications, women with endometrial cancer are more likely to die of cardiovascular disease and other obesity-related illnesses than endometrial cancer itself. This makes an endometrial cancer diagnosis a critical moment to emphasizes the importance of actively managing the underlying issue of obesity in the endometrial cancer survivorship period. Bariatric surgery has shown long-term benefits, including weight loss and reduction of obesity-related comorbidities, and has been linked to a decrease in endometrial cancer incidence. However, bariatric surgery has limitations, such as irreversibility and potential complications. Recent interest in less invasive methods, like bariatric endoscopy, shows promising results in achieving weight loss and improving metabolic profiles. Endoscopic procedures, such as Endomina Endoscopic suture gastroplasty (E-ESG), have shown effectiveness in weight loss and could offer a safer, more accessible alternative to surgery, in particular if associated to a lifestyle modifications program. Efficacy and safety of Bariatric endoscopy has been stressed within the recently published "Guideline of the Italian Society of Surgery of Obesity and Metabolic Diseases on Bariatric Endoscopy in the treatment of obesity and associated complications" that suggest the use of bariatric endoscopy in patients with class I obesity and in patients with class II obesity regardless of the presence of comorbidities, for the treatment of obesity. This study aims to assess the feasibility and safety of the E-ESG procedure in treating obesity in women after curative treatment for endometrial cancer.


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether an endoscopic weight-loss procedure called endoscopic sleeve gastroplasty (ESG) — where the stomach is reduced in size using sutures through a camera-guided tube, without open surgery — can help obese women with endometrial (uterine) cancer lose weight before a hysterectomy, potentially improving surgical outcomes and long-term cancer control. **You may be eligible if...** - You are a woman between 21 and 75 years old - You have endometrial cancer and are scheduled for a hysterectomy with intent to cure - Your BMI is 30 or higher - You are willing to undergo the stomach-reducing procedure and make lasting diet and lifestyle changes **You may NOT be eligible if...** - You have had prior stomach or esophageal surgery that would prevent the procedure - You have uncontrolled diabetes, serious heart disease, or severe liver disease - You use blood thinners that cannot be safely paused - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Centro di Riferimento Oncologico (CRO) - IRCCS Aviano

Aviano, Pordenone, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Roma, Italy

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NCT07397624


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