NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1062210060

Registered date:12/12/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedEndometrial cancer
Date of first enrollment19/07/2023
Target sample size5
Countries of recruitment
Study typeInterventional
Intervention(s)Endometrial cancer tissue is aspirated and collected using manual vacuum aspiration (MVA).

Outcome(s)

Primary OutcomeEndometrium removal rate by vacuum aspiration (%)
Secondary OutcomeUterine 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
GenderFemale
Include criteria1.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 criteria1. Those with active double cancer (other cancers) 2. Underwent endometrial scraping with endometrial cancer 3. Diagnosed with antiphospholipid antibody syndrome and thrombosis

Related Information

Contact

Public contact
Name Keiichiro Nakamura
Address 2-5-1 Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7320
E-mail k-nakamu@cc.okayama-u.ac.jp
Affiliation Okayama University Hospital
Scientific contact
Name Keiichiro Nakamura
Address 2-5-1,Shikata-cho,Kita-ku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7320
E-mail k-nakamu@cc.okayama-u.ac.jp
Affiliation Okayama University Hospital