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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• Princess Margaret Hospital, Toronto, Ontario, Canada

Who to contact

Tara Zad · 416-946-4501 · Tara.Zad@uhn.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04008563.