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

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 74

Contacts and Locations

• Study Contact: Name: Stefano Realdon, MD; Phone Number: 0434659152; Email: stefano.realdon@cro.it

Study Locations

• Italy
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro di Riferimento Oncologico (CRO) - IRCCS Aviano
      • Contact: Stefano Realdon, MD; Phone Number: 0434659152; Email: stefano.realdon@cro.it
  • Roma
    • Roma, Roma, Italy
      • Not yet recruiting
      • Fondazione Policlinico Universitario Campus Bio-Medico
      • Contact: Francesco Maria Di Matteo
      • Principal Investigator: Margareth Martino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with endometrial cancer scheduled for hysterectomy with a curative intent, with BMI ≥ 30 and Willingness to undergo E-ESG and lifestyle modifications program

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the feasibility of E-ESG procedure in obese patients with endometrial cancer.	Absolute and relative frequency of patients with technical success of E-ESG procedure, reported with relative 95% Confidence Interval	up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of patients who refused E-ESG procedure	Evaluation of the number and percentage of women with endometrial cancer and obese who refused E-ESG procedure	up to 4 years
Evaluation of patients who refused E-ESG procedure	Description with absolute and relative frequencies of baseline characteristics of women with endometrial cancer and obese who refused E-ESG procedure	up to 4 years
Evaluation of E-ESG safety in obese endometrial cancer patients.	Absolute and relative frequencies of adverse events	up to 4 years
To evaluate efficacy of E-ESG effects on obesity-associated comorbidities.	Evaluation of % Excess weight loss (EWL) with the formula (Weight loss)/ (Excess weight at T0) x 100 and %TBWL(total body weight loss) with the formula (weight loss) / (weight at T0) x 100 in enrolled patients at 1 year	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	Absolute and relative frequencies of patients that reach a mean excess weight loss (EWL) of more than 25% and a total body weight loss (TBWL) of more than 5% maintained at 1 year (52 weeks)	up to 4 years
To evaluate the change of metabolic serum biomarkers in E-ESG patients	Mean or median difference between baseline values of metabolic serum biomarkers and 52 weeks (T1), and 156 weeks (T2)	up to 4 years
To evaluate the change of gut microbiota	Microbial levels will be described as mean or median, reporting differences in levels ad different time points	up to 4 years
To evaluate Overall Survival in E-ESG	Overall survival will be defined as time between E-ESG and death from any cause or end of follow up, whichever cames first. Data will be described as median survival and interquartile range (IQR) calculated with Kaplan-Meyer method	up to 4 years
To evaluate Disease Free Survival n E-ESG	Overall survival will be defined as time between E-ESG and disease progression or death from any cause or end of follow up, whichever cames first. Data will be described as median survival and interquartile range (IQR) calculated with Kaplan-Meyer method	up to 4 years
To evaluate Recurrence rate in E-ESG	Disease recurrence rate at the end of follow up will be reported as absolute and relative frequency	up to 4 years

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: CRO-2025-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No