Fertility-Sparing Surgery for Endometrial Cancer
(FETCH Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vancouver Coastal Health Research Institute
Must be taking: High-dose progestin
Disqualifiers: Age 40+, Grade 2/3 cancer, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it requires that you have already tried anti-hormone therapy, like high-dose progestin, for at least 6 months before participating.
What data supports the effectiveness of the treatment Hysteroscopic uterine resection for fertility-sparing surgery in endometrial cancer?
Research shows that hysteroscopic endometrial resection can be effective in conservatively treating early endometrial cancer in women who want to preserve their fertility. It has been used successfully in some cases to manage early-stage endometrial cancer, allowing women to achieve pregnancy with assisted reproductive technology.
12345Is hysteroscopic surgery generally safe for humans?
Hysteroscopic surgery is generally considered safe with rare complications, but as procedures become more complex, complications like bleeding, uterine perforation, and fluid overload can occur. Awareness and prevention of these issues help ensure patient safety.
26789How is hysteroscopic uterine resection different from other treatments for endometrial cancer?
Hysteroscopic uterine resection is unique because it allows for the conservative management of early-stage endometrial cancer while preserving fertility, unlike the standard treatment of hysterectomy, which results in infertility. This approach combines surgery with hormone therapy and can lead to a faster return to fertility and shorter remission times.
1241011Eligibility Criteria
This trial is for women under 40 with early-stage endometrial cancer or atypical hyperplasia who haven't improved with hormone therapy and want to keep their fertility. They should have less than a third of the uterus affected, no severe health issues that could complicate surgery, and a reasonable chance to conceive as assessed by a fertility specialist.Inclusion Criteria
I have been on progesterone therapy for at least 6 months.
Progestin therapy did not work for my uterine condition or I couldn't tolerate its side effects.
My biopsy shows early-stage endometrial cancer with limited spread.
+8 more
Exclusion Criteria
I am unable to understand and give consent for my treatment.
I don't have any other cancers or conditions that could affect surgery outcomes.
My Grade I endometrial cancer affects more than one-third of the uterus.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo hysteroscopic endomyometrial resection to treat atypical hyperplasia or Grade I endometrial cancer
1 day
1 visit (in-person)
Follow-up
Participants are monitored for local disease control and complications post-resection
3 months
Multiple visits (in-person)
Long-term Follow-up
Participants are monitored for distant disease control and conception rates
3 years
Participant Groups
The study tests hysteroscopic resection—a surgical procedure using an instrument inserted through the vagina to remove abnormal tissue from the uterus—in patients desiring fertility preservation after unsuccessful hormone treatment for certain uterine conditions.
1Treatment groups
Experimental Treatment
Group I: Hysteroscopic uterine resectionExperimental Treatment1 Intervention
This is a prospective single-arm surgical intervention trial.
Hysteroscopic uterine resection is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Hysteroscopic surgery for:
- Abnormal uterine bleeding
- Endometrial hyperplasia
- Endometrial cancer
- Fibroids
- Polyps
- Uterine adhesions
🇺🇸 Approved in United States as Hysteroscopic surgery for:
- Abnormal uterine bleeding
- Endometrial hyperplasia
- Endometrial cancer
- Fibroids
- Polyps
- Uterine adhesions
- Sterilization
🇨🇦 Approved in Canada as Hysteroscopic surgery for:
- Abnormal uterine bleeding
- Endometrial hyperplasia
- Endometrial cancer
- Fibroids
- Polyps
- Uterine adhesions
🇦🇺 Approved in Australia as Hysteroscopic surgery for:
- Abnormal uterine bleeding
- Endometrial hyperplasia
- Endometrial cancer
- Fibroids
- Polyps
- Uterine adhesions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vancouver General HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
Vancouver Coastal Health Research InstituteLead Sponsor
University of British ColumbiaCollaborator
References
The use of hysteroscopic endometrectomy in the conservative treatment of early endometrial cancer and atypical hyperplasia in fertile women. [2021]To illustrate the effectiveness of hysteroscopic endometrial resection in conservative treatment of early endometrial cancer/atypical hyperplasia in women of reproductive age.
Transcervical endometrial resection in women with menorrhagia: long-term follow-up. [2006]Hysteroscopic endometrial resection is an innovative and conservative surgical technique considered, very often, as an alternative to hysterectomy. The aim of the study was to evaluate long-term efficacy of endometrial resection performed in women with menorrhagia.
[Failure factors in endometrial resection. 196 cases]. [2010]Study of factors affecting risk of failure after hysteroscopic endometrial resection.
Hysteroscopic resection in the management of early-stage endometrial cancer: report of 2 cases and review of the literature. [2018]Although endometrial cancer, the most common gynecologic malignancy, is most often diagnosed in postmenopausal women, it affects young women who wish to preserve fertility. The purpose of this article is to describe 2 cases of stage IA endometrial cancer managed conservatively by a combination of hysteroscopic surgery and medical therapy for fertility-sparing purposes, one of which achieved successful pregnancy using assisted reproductive technology, and review the existing literature on the use of hysteroscopic resection in conservative management of endometrial cancer to preserve fertility. The addition of hysteroscopic resection to conservative management of early-stage endometrial carcinoma may be a way to improve response and recurrence rates in women wishing to preserve fertility and can offer other additional benefits, such as a shorter time period to remission and a faster return to fertility. Key factors to success with this approach include an interdisciplinary approach, thorough patient counseling, and the availability of a team experienced in hysteroscopic resection.
[Long-term results of hysteroscopic resection of endometrial polyps in 367 patients. Role of associated endometrial resection]. [2022]To assess the results of hysteroscopic resection of endometrial polyps and the eventual role of associated endometrial resection.
Complications of hysteroscopic and uterine resectoscopic surgery. [2019]Adverse events associated with hysteroscopic procedures are in general rare, but, with increasing operative complexity, it is now apparent that they are experienced more often. A spectrum of complications exist ranging from those that relate to generic components of procedures such as patient positioning and anesthesia and analgesia, to a number that are specific to intraluminal endoscopic surgery (perforation and injuries to surrounding structures and blood vessels). The response of premenopausal women to excessive absorption of nonionic fluids deserves special attention. There is also an increasing awareness of uncommon but problematic sequelae related to the use of monopolar uterine resectoscopes that involve thermal injury to the vulva and vagina. The uterus that has previously undergone hysteroscopic surgery can behave in unusual ways, at least in premenopausal women who experience menstruation or who become pregnant. Better understanding of the mechanisms involved in these adverse events, as well as the use or development of several devices, have collectively provided the opportunity to perform hysteroscopic and resectoscopic surgery in a manner that minimizes risk to the patient.
Complications of Hysteroscopic and Uterine Resectoscopic Surgery. [2022]Adverse events associated with hysteroscopic procedures are generally rare, but, with increasing operative complexity, it is now apparent that they are experienced more often. There exists a spectrum of complications that relate to generic components of procedures, such as patient positioning, anesthesia, and analgesia, to a number that are specific to intraluminal endoscopic surgery that largely comprise perforation and injuries to surrounding structures and blood vessels. Whereas a number of endoscopic procedures require the use of distending media, the response of premenopausal women to excessive absorption of nonionic fluids used for hysteroscopy is somewhat unique, and deserves special attention on the part the surgeon. There is also an increasing awareness of uncommon but problematic sequelae related to the use of monopolar radiofrequency uterine resectoscopes that involve thermal injury to the vulva and vagina. Furthermore, the uterus that has previously undergone hysteroscopic surgery may behave in unusual ways, at least in premenopausal women who experience menstruation or who become pregnant. Fortunately, better understanding of the mechanisms involved in these adverse events, as well as the use or development of a number of innovative devices, have collectively provided the opportunity to perform hysteroscopic and resectoscopic surgery in a manner that minimizes risk to the patient.
Hysteroscopic resection of endometrial hyperplasia. [2019]To evaluate the efficacy and safety of hysteroscopic resection of endometrial hyperplasia without atypia.
Complications in operative hysteroscopy - is prevention possible? [2017]Operative hysteroscopy in a hospital setting has revolutionized surgical treatment of benign uterine disorders. It is minimally invasive, cost- and time-effective, and may spare patients major surgical interventions. Operative hysteroscopy in a day-case hospital setting is regarded as a safe and well-tolerated procedure with low complication rates. However, prevention of adverse events is crucial in daily practice to optimize patient care. Complications in operative hysteroscopy can be divided into early complications, including bleeding, uterine perforation, infection and fluid overload, or late complications and suboptimal outcomes, such as incomplete resection and intrauterine adhesions. Awareness and knowledge of management of adverse events as well as the use of possible preventative measures will increase the quality and safety of hysteroscopic surgery. The present commentary focuses on these issues as an up-to-date basis for everyday clinical practice.
Hysteroscopic surgery for conservative management in endometrial cancer: a review of the literature. [2020]Endometrial cancer is the most common gynaecologic malignancy, usually diagnosed in postmenopausal women. However, an incidence rate of 2-14% of cases consisting of women under the age of 45 years old has been reported. Multiple reports have described the conservative treatment of this tumour in selected patients with the objective of preserving fertility. In this article, we review the literature to evaluate the results of conservative treatment of endometrial cancer with hysteroscopic resection.
Fertility-preserving treatment of stage IA, well-differentiated endometrial carcinoma in young women with hysteroscopic resection and high-dose progesterone therapy. [2019]The standard treatment for endometrial cancer is surgery with hysterectomy. However, this procedure will cause infertility in young women who desire to preserve pregnant ability. Conservative management with hormone therapy has been shown to be satisfactory in both tumor control and fertility preservation. Recently, hysteroscopic tumor resection followed by progestin therapy has been reported to be an alternative strategy. In this study we present our experience with this approach.