A randomized trial on the management of low-grade squamous intraepithelial lesion cytology interpretations

Am J Obstet Gynecol. 2003 Jun;188(6):1393-400. doi: 10.1067/mob.2003.462.


Objective: This study was undertaken to compare alternative strategies for the initial management of low-grade squamous intraepithelial lesion (LSIL) cytology.

Study design: A total of 1572 women with a community-based LSIL interpretation were randomly assigned to immediate colposcopy, triage based on enrollment HPV DNA testing and liquid-based cytology at a colposcopy referral threshold of high-grade squamous intraepithelial lesion (HSIL), or conservative management based on repeat cytology at a referral threshold of HSIL. All arms included 2 years of semiannual follow-up and colposcopy at exit. Loop electrosurgical excision procedure was offered to women with histologic diagnoses of cervical intraepithelial neoplasia (CIN) grade 2 or 3 at any visit or persistent CIN grade 1 at exit. The main study end point was 2-year cumulative diagnosis of CIN grade 3.

Results: The 2-year cumulative diagnosis of CIN grade 3 was approximately 15% in all study arms. The HPV triage arm was closed early because more than 80% of women were HPV positive, precluding efficient triage. The immediate colposcopy strategy yielded 55.9% sensitivity for cumulative cases of CIN grade 3 diagnosed over 2 years. A conservative management strategy of repeat cytology at the HSIL threshold referred 18.8% of women while detecting 48.4% of cumulative CIN grade 3. At lower cytology thresholds, sensitivity would improve but would ultimately yield unacceptably high referral rates.

Conclusion: LSIL cytology is best managed by colposcopy initially, because there was no useful triage strategy identified. Management of these patients, after colposcopy to rule out immediately overt CIN grade 2 or 3, needs to be determined.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Alabama
  • Carcinoma, Squamous Cell / diagnosis*
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / surgery
  • Carcinoma, Squamous Cell / virology
  • Cervical Intraepithelial Neoplasia / diagnosis*
  • Cervical Intraepithelial Neoplasia / pathology
  • Cervical Intraepithelial Neoplasia / surgery
  • Cervical Intraepithelial Neoplasia / virology
  • Colposcopy / standards*
  • DNA, Viral / genetics
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Staging
  • Oklahoma
  • Papillomaviridae / genetics*
  • Papillomaviridae / isolation & purification
  • Pennsylvania
  • Sensitivity and Specificity
  • Triage
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / pathology
  • Uterine Cervical Neoplasms / surgery
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears / standards*
  • Washington


  • DNA, Viral