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

Sponsor
Centro di Riferimento Oncologico - Aviano
Study ID
NCT07397624
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Feb 9, 2026
Start date
Jan 8, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
74 participants (estimated)

Primary Outcome Measure

Evaluation of the feasibility of E-ESG procedure in obese patients with endometrial cancer. [ Time Frame: up to 4 years ]

Central Contacts

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Endometrial cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials

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