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

NCT07397624 | Recruiting

• 1 other identifier: CRO-2025-016
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Evaluation of patients who refused E-ESG procedure

  up to 4 years

• Evaluation of patients who refused E-ESG procedure

  up to 4 years

• Evaluation of E-ESG safety in obese endometrial cancer patients.

  up to 4 years

• To evaluate efficacy of E-ESG effects on obesity-associated comorbidities.

  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

  up to 4 years

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (2)

Centro di Riferimento Oncologico (CRO) - IRCCS Aviano

Aviano, Pordenone, 33081, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Roma, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Stefano Realdon, MD

CONTACT

0434659152; stefano.realdon@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

IT (2)