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Endometrial CancerESG-ENDONCT07397624

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

An observational study of Endometrial Cancer, run by Centro di Riferimento Oncologico - Aviano at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 75 years, women only
Conditions the study is for
Endometrial Cancer
How many people
74 participants
Where
2 sitesItaly
Study dates
8 Jan 2026to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stefano Realdon, MD contact

0434659152

stefano.realdon@cro.it

Italy2 sites, 2 recruiting

  • Centro di Riferimento Oncologico (CRO) - IRCCS Aviano

    Aviano, Pordenone, 33081

    Stefano Realdon, MD, 0434659152, stefano.realdon@cro.it

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, Roma

    Francesco Maria Di Matteo

    Margareth Martino

    Not yet recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Medical subject headings
Endometrial Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 4 years

Secondary outcomes (10)

  1. 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

    Measured: up to 4 years

  2. 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

    Measured: up to 4 years

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

    Absolute and relative frequencies of adverse events

    Measured: up to 4 years

  4. 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

    Measured: up to 4 years

  5. 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)

    Measured: up to 4 years

  6. 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)

    Measured: up to 4 years

  7. To evaluate the change of gut microbiota

    Microbial levels will be described as mean or median, reporting differences in levels ad different time points

    Measured: up to 4 years

  8. 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

    Measured: up to 4 years

  9. 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

    Measured: up to 4 years

  10. To evaluate Recurrence rate in E-ESG

    Disease recurrence rate at the end of follow up will be reported as absolute and relative frequency

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start8 Jan 2026
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397624
Sponsor's protocol ID
CRO-2025-016
Acronym
ESG-ENDO
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
12 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Cancer, run by Centro di Riferimento Oncologico - Aviano at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stefano Realdon, MD (0434659152, stefano.realdon@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the feasibility of E-ESG procedure in obese patients with endometrial cancer. (time frame: up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397624.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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