Cervical intraepithelial neoplasia
Conditions
Interventions
Endoscopic cervical observation before cervical cancer surgery
Sponsors
Dohi Osamu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of detection of CIN2+ in Uterine Cervical Endoscopy (UCE) for pathology final tissue diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactOsamu Dohi
University hospital kyoto prefectual university of medicine
Outcome results
None listed