Cervical Intraepithelial Neoplasia Grade I, HPV Disease
Conditions
Keywords
Cervical HR-HPV-related low-grade squamous intraepithelial lesion
Brief summary
The majority of low-grade pre-invasive lesions of cervix (low-grade squamous intraepithelial lesions, LSIL).will regress spontaneously over 2 years and immediate treatment may not be necessary. According to the Hong Kong College of Obstetricians and Gynaecologists (HKCOG), if a low-grade lesion is confirmed by colposcopy and biopsy, the patient can be observed and followed up with HPV testing or co-testing at 12 months, irrespective of age. This randomized controlled study is to determine whether high-intensity focused ultrasound (HIFU) treatment of low-grade pre-invasive lesions of cervix, can cause regression of these lesions in more patients within a specific time when compared to observation as a standard management according to HKCOG Guidelines. All eligible patients will be randomized in a 1:1 ratio into 2 groups: high-intensity focused ultrasound (HIFU) or Observation group. Background information of the patients such as age, parity, body mass index, smoking status and the presence of chronic medical disease will be collected. All patients with cervical HR-HPV status will be tested. Patients randomized into HIFU group will receive HIFU treatment within 2 weeks after randomization. Those randomized into Observation group will have no intervention. All patients will attend follow-up at 6 and 12 months after randomization, during which cervical smear for cytology (with cytopathologists blinded to the treatment group) and HR-HPV testing will be performed. The rate of cytological LSIL regression and HR-HPV clearance rates at 6 and 12 months in both groups will be analyzed. Patients will be referred back to colposcopy clinic for repeat colposcopy if needed according to HKCOG Guidelines. At the 12-month follow-up visit, if referral to repeat colposcopy is not needed, patients will be referred back to their primary care physicians, Department of Health Family Health Service, Family Planning Association or other primary care centres for follow-up cervical smears.
Interventions
DEVICEHIFU treatment
HIFU for the management of cervical HR-HPV-related LSIL
Sponsors
Queen Mary Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Pre-menopausal women aged 18 years old or above. 2. Women had satisfactory colposcopy for abnormal cervical smear with positive HR-HPV test, with histologically confirmed diagnosis of cervix LSIL or CIN1.
Exclusion criteria
1. Women who are pregnant or breast feeding at the time of planned HIFU treatment. 2. Women without HR-HPV, or previously treated for CIN or cervical cancer. 3. Women not able to attend follow up. 4. Women with evidence of acute genital tract infection. 5. Women with significant autoimmune diseases, immunodeficiency diseases, severe cardiac, hepatic, renal, and coagulation dysfunctions. 6. Women not able to give consent. Participants be considered withdrawn from study or excluded from analysis 1. Formally recruited into the study but withdraw from the study after randomization. 2. Do not attend both follow-up appointments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of HIFU in reducing cervical HR-HPV related LSIL | 12 months | \- To determine the efficacy of HIFU in reducing cervical HR-HPV-related LSIL as evident by the reduction in the number of persistent cervical smear cytological abnormality when compared to observation as a standard management according to HKCOG Guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of HIFU in clearing cervical HR-HPV | 12 months | The efficacy of HIFU in clearing cervical HR-HPV-related HPV will be compared to observation. Both HIFU and Observation group will have HPV testing at 6 and 12 months after recruitment, and the incidence of HR-HPV in both groups will be analyzed. |
| Efficacy of HIFU in reducing the need for repeat colposcopy | 12 months | The number of participants that required repeat colposcopy for persistent abnormal cervical smear in HIFU and Observation group will be compared. |
| Safety and side effects of HIFU in the treatment of cervical LSIL | 6 months | The treatment time, intraoperative blood loss, intraoperative pain level using visual analog scale (VAS) pain score, and other discomfort are recorded. Patients will be called in 1 week for any postoperative side effects or complications such as discharge, bleeding, pain (including the VAS pain score) or discomfort, for which, additional telephone or clinic follow-up will be arranged if necessary. The visual analog scale pain score will range from a minimum value of 0 to a maximum value of 10, with higher scores mean worse pain level. |
| Patient satisfaction in using HIFU in the treatment of cervical LSIL | 1 months | The level of patient satisfaction in using HIFU in the treatment of cervical LSIL level will be evaluated using visual analog scale (VAS) score, immediately after, and 1 month after HIFU treatment. The visual analog scale patient satisfaction score will range from a minimum value of 0 to a maximum value of 5, with higher scores mean higher satisfaction. |
Contacts
CONTACTVincent YT Dr. Cheung, MBBS, MRCOG, FHKAM, FRCOG
Outcome results
None listed