Endoscopic suture gastroplasty to treat obesity in women with endometrial cancer

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

This trial will try endoscopic suture gastroplasty plus a lifestyle program to help women with endometrial cancer and obesity lose weight and lower obesity-related health risks.

Quick facts

• Study type: Observational
• Enrollment: 74 (estimated)
• Ages: 21 Years to 75 Years
• Sex: Female
• Sponsor: Centro di Riferimento Oncologico - Aviano (Academic / other)
• Locations: 2 sites (Aviano, Pordenone and 1 other locations)
• Trial ID: NCT07397624 on ClinicalTrials.gov

What this trial studies

This observational protocol enrolls women with endometrial cancer scheduled for curative hysterectomy who have a BMI ≥ 30 and are willing to undergo endoscopic suture gastroplasty (E-ESG) alongside a structured lifestyle and diet program. Participants will receive E-ESG (an endoscopic stomach-suturing procedure) and be followed with routine visits, laboratory testing, and diet counseling to monitor weight change, metabolic markers, and safety outcomes. The trial excludes patients with prior foregut or complex gastrointestinal surgery, prior bariatric operations, or other conditions that increase procedural risk. The goal is to characterize feasibility, weight-loss effect, metabolic benefit, and procedure safety in this specific cancer survivorship population.

Who should consider this trial

Good fit: Ideal candidates are women aged 21–75 with endometrial cancer scheduled for hysterectomy, a BMI of 30 or higher, who can consent, live within travel distance of the sites, and agree to undergo E-ESG plus lifelong dietary and lifestyle follow-up.

Not a fit: Patients unlikely to benefit include those with prior complex foregut or bariatric surgery, known abdominal adhesions or GI sequelae, BMI below 30, or those unwilling/unable to comply with the required dietary restrictions and follow-up.

Why it matters

Potential benefit: If successful, E-ESG could provide a less invasive weight-loss option that reduces obesity-related complications and improves long-term health for women after endometrial cancer treatment.

How similar studies have performed: Bariatric surgery has demonstrated durable weight loss and reduced comorbidities, and endoscopic approaches like ESG have shown promising weight-loss and metabolic results in other populations, but data specifically in endometrial cancer patients remain limited.

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

Where this trial is running

Aviano, Pordenone and 1 other locations

• Centro di Riferimento Oncologico (CRO) - IRCCS Aviano — Aviano, Pordenone, Italy (Recruiting)
• Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Roma, Italy (Not_yet_recruiting)

Study contacts

• Study coordinator: Stefano Realdon, MD

Conditions Endometrial Cancer