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Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

RECRUITINGN/ASponsored by University Health Network, Toronto
Actively Recruiting
PhaseN/A
SponsorUniversity Health Network, Toronto
Started2021-05-14
Est. completion2025-10-31
Eligibility
Age18 Years – 41 Years
SexFEMALE
Healthy vol.Accepted

Summary

A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.

Eligibility

Age: 18 Years – 41 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* BMI ≥ 35
* Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
* Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT)
* ECOG status \<2
* Desire for fertility preservation
* No contraindications to progestin intrauterine device (IUD)
* Have signed an approved informed consent form

Exclusion Criteria:

* Evidence of myometrial invasion or extra-uterine disease on imaging
* High grade or p53 endometrial cancer
* History of other malignancies, except if curatively treated with no evidence of disease for \> 5 years
* Previous major upper abdominal surgery (ex. previous bariatric surgery, splenectomy, partial gastrectomy, liver resection, bowel resection). Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion.
* Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded.
* Contraindications to sleeve gastrectomy
* Medical co-morbidity with end-organ dysfunction
* Unable to understand and participate in the informed consent process
* Currently pregnant
* Active smoking in ≤6 months
* Active substance use disorder
* Current untreated or severe psychiatric issue

Conditions4

Atypical HyperplasiaBariatric Surgery CandidateCancerEndometrial Cancer

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