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

Official title

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

Overview

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.

Detailed description

Obesity increases the risk of endometrial cancer, with higher 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.

Primary outcome measures

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

Secondary outcome measures (10)

• Evaluation of patients who refused E-ESG procedure [Time frame: up to 4 years]
• Evaluation of patients who refused E-ESG procedure [Time frame: up to 4 years]
• Evaluation of E-ESG safety in obese endometrial cancer patients. [Time frame: up to 4 years]
• To evaluate efficacy of E-ESG effects on obesity-associated comorbidities. [Time frame: up to 4 years]
• Evaluation of percentage of patients that reach a mean excess weight loss (EWL) of more than 25% and total body weight loss (TBWL) of more than 5% maintained at 1 year (52 weeks) in E-ESG and lifestyle modifications group [Time frame: up to 4 years]
• To evaluate the change of metabolic serum biomarkers in E-ESG patients [Time frame: up to 4 years]
• To evaluate the change of gut microbiota [Time frame: up to 4 years]
• To evaluate Overall Survival in E-ESG [Time frame: up to 4 years]
• To evaluate Disease Free Survival n E-ESG [Time frame: up to 4 years]
• To evaluate Recurrence rate in E-ESG [Time frame: up to 4 years]

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, stomach, or any type of hiatal hernia surgery
• Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenoses
• Gastrointestinal stromal tumors, history of premalignant gastric lesions (advanced atrophic gastritis), history of familial and non-familial adenomatous syndromes
• A gastric mass or gastric polyps > 1 cm in size
• A hiatal hernia > 4 cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope
• Achalasia or any other severe esophageal motility disorder
• Severe coagulopathy
• Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis, or intractable constipation
• Hepatic insufficiency or cirrhosis
• Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing
• Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
• Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
• Patients receiving daily prescribed treatment with high dose aspirin (> 80 mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants
• Patients who are pregnant or breast-feeding
• Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs
• Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
• Subjects who are taking corticosteroids, immunosuppressants, and narcotics
• Subjects who are taking diet pills
• Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease
• Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer
• Diagnosis of autoimmune connective tissue disorder (e.g., lupus, erythematosus, scleroderma) or immunocompromised
• Specific diagnosed genetic disorder such as Prader Willi syndrome
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
• Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 2 centers

• Centro di Riferimento Oncologico (CRO) - IRCCS Aviano — Aviano
• Fondazione Policlinico Universitario Campus Bio-Medico — Roma

Identifiers

NCT: NCT07397624 · CRO-2025-016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗