Feasibility and safety of endometrial curretage surgery for early endometrial cancer using manual vacuum aspiration

JRCT ID: jRCT1062210060

Registered date:12/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Endometrial cancer
• Date of first enrollment: 19/07/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Endometrial cancer tissue is aspirated and collected using manual vacuum aspiration (MVA).

Outcome(s)

• Primary Outcome: Endometrium removal rate by vacuum aspiration (%)

Secondary Outcome

Uterine perforation rate
Operation time
Bleeding volume
Adverse events and side effects that occurred from the start of vacuum aspiration to the end of post-observation
Confirmation of histology

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Female

Include criteria

1.Those who can obtain written consent from their own involuntary research participation
2. Early-stage endometrial cancer (atypical endometrial hyperplasia and early-stage endometrial cancer (endometrioid carcinoma G1/2) )who wish to be pregnant
3. Preoperative diagnostic imaging tests have confirmed no endometrial muscular invasion or lymph node metastasis
4. 20 to 40 years at the time of registration
5. General status is 0 or 1
6. No previous history of radiation therapy, chemotherapy, or surgery
7. Those with major organ functions
Neutrophil count 2000 / mm3 or more , Hemoglobin 10g / dl or more (correction by blood transf
usion is permitted) , Platelet count 100,000 / mm3 or more , Total bilirubin 1.5mg / dl AST (GOT) a
nd ALT (GPT) 100 IU / l or lessSerum creatinine 1.2 mg / dl or less
8. The following tests must be performed within 28 days prior to the operation,The ECG test
should not show normal or abnormal finding s requiringtreatment.

Exclude criteria

1. Those with active double cancer (other cancers)
2. Underwent endometrial scraping with endometrial cancer
3. Diagnosed with antiphospholipid antibody syndrome and thrombosis

Related Information

• Primary Sponsor: Nakamura Keiichiro