Phase III study of Uterine Cervical Endoscopy versus Colposcopy (UCE trial)
- Conditions
- Uterine cervical neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 310
- Patients with a positive Pap smear test result of ASC-US, ASC-H, LSIL, or HSIL If there are multiple candidates on the same day due to the limited number of tests possible per day, HSIL and ASC-H will be given priority for entry.
- Patients who are age between 18 and 64 years
- Patients with provision of written informed consent
- Patients who have already undergone colposcopic examination for the current cytological abnormality
- Patients who already have a confirmed diagnosis of CIN or carcinoma for the current cytological abnormality
- Those who are postmenopausal.
- Patients taking antithrombotic drugs or with a blood disorder for which a biopsy is contraindicated
- Patients with mental illness and judged inappropriate for study participation by the attending physician
- Patients who are pregnant or possibly pregnant
- Patients with a history of uterine cervical operation
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Sensitivity to detect CIN2+ in each biopsy tissue of UCE and colposcopy in each case Definition of CIN2+ includes CIN2, CIN3, AIS(Adenocarcinoma in situ), ICC(Invasive cervical cancer).
- Secondary Outcome Measures
Name Time Method Acceptance by the examinee evaluated by the Visual Analogue Scale (VAS) score (0-10 cm), a pain score for the examination using a questionnaire.
sensitivity and specificity of CIN1+ in both groups by case or lesion
sensitivity and specificity of CIN2+ based on histopathological stage in both groups in of cases or lesion units
evaluation of the eligibility of endoscopic and punch biopsy specimens obtained in each of the two groups and the validity of the pathological diagnosis (I) Depth diameter of the subepithelial stroma of the biopsy specimen (distance from the upper margin of the stroma to the deepest stroma)
(II) Evaluation of subepithelial stromal tissue (presence or absence of subepithelial stromal tissue and presence or absence of stromal invasion)
(III) Pathology diagnostic compliance rate for intraepithelial tumors and subepithelial invasive carcinomas.
All biopsy specimens will be collected at one location, blinded as to which group they belong to, and a central batch decision will be made by a total of three pathologists, one specializing in gynecologic tumor pathology and two specializing in tumor pathology. One gynecologic oncologist with expertise in colposcopic diagnosis and biopsy will be involved in the audit from a clinical standpoint. Microimages are always stored in case additional analysis is required.examination time endoscope insertion to removal vs. cusco insertion to removal
Safety endpoints Percentage of adverse events (Grade 2 or higher):
bleeding (difficulty in stopping bleeding), Post-biopsy bleeding requiring hemostatic treatment (gauze compression, electrocoagulation, etc.), Tissue inflammation due to acetic acid requiring treatment, Peritonitis due to bacterial infection, Abdominal pain (pain inability to stand up), Gas embolization, Intra-abdominal seeding, Respiratory distress, Shock, Death, Failure of equipmentfalse negative rate of CIN2+ in the UCE group *False negative is defined as the detection of CIN2+ that was not noted on the initial test in each group on a case-by-case basis.
examinee acceptability to the patient discomfort, embarrassment, biopsy-related pain, as assessed by VAS score.
examinee acceptability: comparison of pain between the two subject groups with and without biopsy evaluated by VAS score
examinee acceptability: percentage of both groups for the next desired test assessed by VAS score
percentage of successful circumferential cervical observation in both groups Examine the performance of each test method itself as it relates to securing the field of view of the cervix.