Note: This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary. The recommendations that follow are based on the previous version of the guideline.
The ratings of the strength of recommendation (A-E), the quality of the evidence (I-III), and terminology used by the consensus conference (recommended, preferred, acceptable, unacceptable) are repeated at the end of the Major Recommendations.
Recommendations for Managing Women with Biopsy-confirmed CIN-1
Women with Satisfactory Colposcopic Examination
Management options for women with biopsy-confirmed cervical intraepithelial neoplasia grade 1 (CIN-1) are follow-up without treatment or treatment with the use of ablative or excisional modalities (see Table II in the original guidelines). Follow-up with a program of either repeat cervical cytology, at 6 and 12 months, or human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing for high-risk types of HPV at 12 months, is the preferred management approach for women with biopsy-confirmed CIN-1 and a satisfactory colposcopic examination (AII).
When follow-up is used, referral to colposcopy is preferred if a repeat cytology is reported as atypical squamous cells (ASC) or greater or the woman is high-risk HPV DNA positive at 12 months (AII).
After 2 negative, consecutive cervical cytology tests or a negative DNA test for high-risk types of HPV at 12 months, it is preferred that patients return to annual cytologic screening (BII).
In clinical settings where colposcopy is available, a combination of repeat cytology and colposcopic examination at 12 months is an acceptable approach to follow-up (AII).
Women found to have cytologic or combined cytologic and colposcopic regression during follow-up continue to be at higher risk, and it is recommended that they have follow-up with repeat cytology at 12 months (BIII).
The decision to treat persistent CIN-1 should be based on patient and provider preferences (BIII).
Provided the colposcopic examination is satisfactory and treatment is selected, the following treatment modalities for biopsy-confirmed CIN-1 are considered acceptable: cryotherapy, electrofulguration, laser ablation, cold coagulation, and loop electrosurgical excision procedure (LEEP) (AI). If treatment is selected, the choice of treatment should be determined by the judgment of the clinician and should be guided by experience, resources, and clinical value for the specific patient (AI).
It is recommended that endocervical sampling be performed before ablation of CIN-1 (AII).
Excisional modalities are preferred for patients who have recurrent biopsy-confirmed CIN-1 after undergoing previous ablative therapy (BII).
Women with Unsatisfactory Colposcopic Examination
The preferred treatment for patients with biopsy-confirmed CIN-1 and an unsatisfactory colposcopic examination is a diagnostic excisional procedure (i.e., loop electrosurgical excision procedure, laser conization, or cold-knife conization) (AII).
Exceptions where follow-up are acceptable are pregnant and immunosuppressed women (see CIN-2 and CIN-3 special circumstances), and adolescent women in whom, based on limited experience, CIN-2 and CIN-3 are rare in the setting of biopsy-confirmed CIN-1 and an unsatisfactory colposcopy (CIII).
Unacceptable Treatment Approaches
Ablative procedures are unacceptable for CIN-1 in patients with an unsatisfactory colposcopic examination (EII).
Podophyllin or podophyllin-related products are unacceptable for use in the vagina or on the cervix (EII).
Hysterectomy as the primary and principal treatment for biopsy-confirmed CIN-1 is unacceptable (EII).
Recommendations for Managing Women with CIN-2,3
Initial Management of Biopsy-confirmed CIN-2,3
Management decisions in women with biopsy-confirmed CIN-2,3 are determined by whether the colposcopic examination is classified as satisfactory or unsatisfactory, (see Table II in the original guideline document). Both excision and ablation of the transformation zone are acceptable for women with biopsy-confirmed CIN-2,3 and a satisfactory colposcopy (AI). However, in patients with recurrent CIN-2,3, excisional modalities are preferred (AII). A diagnostic excisional procedure is recommended for women with biopsy-confirmed CIN-2,3 and unsatisfactory colposcopy (AII).
Observation of CIN-2,3 with sequential cytology and colposcopy is unacceptable except in special circumstances (see below) (EII).
Hysterectomy is unacceptable as primary therapy for CIN-2,3 (EII).
Follow-up after Treatment of Biopsy-confirmed CIN-2,3
After treatment of CIN-2,3, follow-up using either cervical cytology or a combination of cervical cytology and colposcopy at 4- to 6-month intervals until at least 3 cytologic results are "negative for squamous intraepithelial lesion or malignancy" is acceptable (AII). Annual cytology follow-up is recommended thereafter (AII).
During cytologic follow-up, the recommended threshold for referral to colposcopy is a result of atypical squamous cells (ASC) or greater (AII).
HPV testing performed at least 6 months after treatment is acceptable for surveillance (BII). If high-risk types of HPV are identified, colposcopy is recommended (BIII). If HPV testing is negative, triage to annual cytology follow-up is recommended (BIII).
Repeat conization or hysterectomy based on a single positive HPV test that is not corroborated by other findings (cytology, colposcopy, histology) is unacceptable (DIII).
If CIN is identified at the margins of a diagnostic excisional procedure or in a postprocedure endocervical sampling, it is preferred that the 4- to 6-month follow-up visit include a colposcopic examination and an endocervical sampling (BII). When CIN-2,3 is identified at the endocervical margins or in the endocervical sampling obtained after the diagnostic excisional procedure, a repeat diagnostic excisional procedure is acceptable (AII).
Hysterectomy is acceptable in this situation when repeat diagnostic excision is not feasible (BII). Hysterectomy is acceptable for treatment of recurrent/persistent biopsy-confirmed CIN-2,3 (BII).
Special Circumstances
Observation with colposcopy and cytology at 4- to 6-month intervals for 1 year is acceptable for adolescents with biopsy-confirmed CIN-2, provided colposcopy is satisfactory, endocervical sampling is negative, and the patient accepts the risk of occult disease (BII).
Ablation or excision is required for adolescent women with CIN-3 (BIII).
Definitions:
Strength of Recommendation
- Good evidence for efficacy and substantial clinical benefit support recommendations for use.
- Moderate evidence for efficacy or only limited clinical benefit supports recommendation for use.
- Evidence for efficacy is insufficient to support a recommendation for or against use, but recommendations may be made on other grounds.
- Moderate evidence for lack of efficacy or for adverse outcome supports a recommendation against use.
- Good evidence for lack of efficacy or for adverse outcome supports a recommendation against use.
Quality of Evidence
- Evidence from at least one randomized controlled trial
- Evidence from at least one clinical trial without randomization, from cohort or case-controlled analytic studies (preferably from more than one center), or from multiple time-series studies, or dramatic results from uncontrolled experiments
- Evidence from opinions of respected authorities based on clinical experience, descriptive studies, or reports of expert committees
Terminology*
Recommended: Good data to support use when only one option is available.
Preferred: Option is the best (or one of the best) when there are multiple other options.
Acceptable: One of multiple options when either there are data indicating that another approach is superior or when there are no data to favor any single option.
Unacceptable: Good data against use.
*The assignment of these terms represents an opinion or vote by the consensus conference, and the assignment is not directly linked to the "strength of the recommendation" or the "quality of the evidence."
