Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * Women with endometrial cancer scheduled for hysterectomy with a curative intent * Age 21-75 * BMI ≥ 30 * Willingness to undergo E-ESG and lifestyle modifications program * Willingness to comply with the substantial lifelong dietary restrictions required by the procedure * Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling * Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits * Ability to give informed consent Exclusion Criteria: * History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy) * Prior gastrointestinal surgery with sequelae, i.e., obstruction, and/or adhesive peritonitis or known abdominal adhesions * Prior open or laparoscopic bariatric surgery * Prior surgery of any kind on the esophagus, stom