An observational study in Endometrial Cancer, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 2 sites in Italy. Open to female participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Centro di Riferimento Oncologico - Aviano · Observational
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.
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 74 is below the median of 179 across 331 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Centro di Riferimento Oncologico - Aviano is the lead sponsor of 51 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with endometrial cancer scheduled for hysterectomy with a curative intent, with BMI ≥ 30 and Willingness to undergo E-ESG and lifestyle modifications program
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: up to 4 years
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
Time frame: 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
Time frame: up to 4 years
Evaluation of E-ESG safety in obese endometrial cancer patients.
Absolute and relative frequencies of adverse events
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 4 years
Started Jan 2026 (actual). Primary completion is estimated for Dec 2029, 47 months after the start.
Of 130 non-industry observational studies under Endometrial Neoplasms, half reached primary completion within 105 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 206. This study's planned 47 months is below that.
Counting every sponsor, half of 150 studies reached it within 105 months; a quarter within 32 and three quarters within 207.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Centro di Riferimento Oncologico - Aviano