Actively Recruiting

Age: 21Years - 75Years
FEMALE
NCT07397624

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

Led by Centro di Riferimento Oncologico - Aviano · Updated on 2026-02-12

74

Participants Needed

2

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with endometrial cancer scheduled for hysterectomy with a curative intent
  • Age 21 to 75 years
  • Body Mass Index (BMI) of 30 or higher
  • Willingness to undergo E-ESG and participate in a lifestyle modifications program
  • Willingness to comply with lifelong dietary restrictions required by the procedure
  • Willingness to follow protocol requirements including signed informed consent, routine follow-up visits, laboratory tests, and diet counseling
  • Living within reasonable distance to the investigator's office and able to travel for follow-up visits
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • History of foregut or gastrointestinal surgery except uncomplicated cholecystectomy or appendectomy
  • Prior gastrointestinal surgery with complications such as obstruction, adhesive peritonitis, or known abdominal adhesions
  • Previous open or laparoscopic bariatric surgery
  • Prior surgery on the esophagus, stomach, or hiatal hernia surgery
  • Inflammatory gastrointestinal diseases including severe esophagitis, gastric or duodenal ulceration, cancer, Crohn's disease
  • Conditions causing potential upper gastrointestinal bleeding like varices or congenital anomalies
  • Gastrointestinal stromal tumors, premalignant gastric lesions, or adenomatous syndromes
  • Gastric mass or polyps larger than 1 cm
  • Hiatal hernia larger than 4 cm or severe/intractable gastro-esophageal reflux symptoms
  • Structural abnormalities in esophagus or pharynx impeding endoscope passage
  • Achalasia or severe esophageal motility disorders
  • Severe coagulopathy
  • Serious health conditions unrelated to weight increasing endoscopy risk
  • Motility disorders like gastroparesis or intractable constipation
  • Liver failure or cirrhosis
  • Use of intragastric device prior to study
  • Active psychological issues preventing lifestyle program participation
  • Unwillingness to participate in medically supervised diet and behavior modification program
  • Unwillingness or inability to take prescribed proton pump inhibitors
  • Daily use of high-dose aspirin, anti-inflammatory agents, anticoagulants, or gastric irritants
  • Pregnancy or breastfeeding
  • Severe cardiopulmonary or other serious organic diseases
  • Use of medications affected by gastric emptying changes such as anti-seizure or anti-arrhythmic drugs
  • Use of corticosteroids, immunosuppressants, narcotics, or diet pills
  • Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease
  • Pre-existing respiratory diseases requiring steroids, pneumonia, or cancer
  • Autoimmune connective tissue disorders or immunocompromised state
  • Genetic disorders like Prader Willi syndrome
  • Eating disorders including night eating syndrome, bulimia, binge eating, or compulsive overeating
  • Known endocrine disorders affecting weight such as uncontrolled hypothyroidism

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Centro di Riferimento Oncologico (CRO) - IRCCS Aviano

Aviano, Pordenone, Italy, 33081

Actively Recruiting

2

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Roma, Italy

Not Yet Recruiting

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Research Team

S

Stefano Realdon, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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