Prospective study of evaluation of the usefulness of image-enhanced endoscopic diagnosis in uterine cervical intraepithelial tumors.

JRCT ID: jRCTs052240237

Registered date:06/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Cervical intraepithelial neoplasia
• Date of first enrollment: 06/01/2025
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Endoscopic cervical observation before cervical cancer surgery

Outcome(s)

• Primary Outcome: Sensitivity of detection of CIN2+ in Uterine Cervical Endoscopy (UCE) for pathology final tissue diagnosis.

Secondary Outcome

1)Percentage of irregular IPCL(intraepithelial papillary capillary loops)and white epithelium detected by image-enhanced endoscopic observation (BLI magnification).
2)Characteristic findings and detection rate of CIN2+ in image-enhanced endoscopic observations (LCI observations).
3)Characteristic findings and detection rate of CIN2+ in image-enhanced endoscopy under acetic acid processing (BLI magnification and LCI) compared to white light under acetic acid processing.
4)Range diagnostic accuracy of CIN2+ by image-enhanced endoscopy and acetic acid-processed image-enhanced endoscopy.
5)Comparison of detection sensitivity and range diagnostic accuracy for CIN2+ with colposcopy.
6)Percentage of successful uterine cervical circumference observation by UCE/colposcopy.
7)Sample size and collection rate in uterine epithelial tissue biopsies.
8)Coincident ratio rate between biopsy and final resection pathology diagnosis.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Female

Include criteria

1) Patients with a diagnosis of cervical intraepithelial neoplasia (CIN) grade 2+ by colposcopy or biopsy and undergoing conical resection or total hysterectomy.
2) The patient is aged 18 years and above and below 65 years (as of the date of obtaining written consent).
3) Written consent is obtained from the patient prior to enrolment in the study.

Exclude criteria

1) Patients with a history of cervical surgery.
2) Patients who are pregnant or possibly pregnant.
3) Patients with any of the following complications.
i) Severe infections or organ failure.
ii) Carcinomas undergoing chemotherapy or radiotherapy.
iii) Thrombocytopenia or blood coagulation disorders with bleeding tendency.
4) For other safety reasons, the Principal Investigator or a Sub-Principal Investigator decides that participation in the study is not appropriate.

Related Information

• Primary Sponsor: Dohi Osamu
• Source(s) of Monetary Support: Source of Monetary Support Japan Agency for Medical Research and Development