Module
Introduction
- Excision is widely used as treatment for high-grade squamous intraepithelial lesions (HSIL) of the uterine cervix (cervical intraepithelial neoplasia [CIN2 and CIN3]).* It is preferred over ablation:
- With large lesions (> 75% of cervix area)
- With large lesions (> 75% of cervix area)
- With lesions extending into the endocervical canal
- If the transformation zone is not fully visualized
- LEEP is usually an office procedure performed under local anesthesia.
- CKC is performed in the operating room usually with general or regional anesthesia.
- Excision provides tissue for histologic examination. It:
- Reduces risk of missing occult invasive cancer
- Allows assessment of surgical margins
- Success rates high with both LEEP and CKC
- Risk of recurrence lower with CKC
- Perinatal risks in subsequent pregnancy is higher with CKC
*LAST terminology is used in this module
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Observation
- Active monitoring of low grade squamous intraepithelial lesion (LSIL) (CIN1) lesion using repeat cytology and HPV DNA testing
- Active monitoring of HSIL (CIN2, CIN3) or cytology/histology discrepancy in young women with colposcopy and cytology
Ablation
- Destruction of the entire transformation zone
Excision (LEEP and CKC)
- Removal of the transformation zone
- Provides tissue for histopathology evaluation
-
Management is based on risk, not results
- Recommendations of colposcopy, treatment, or surveillance will be based on a patient’s risk of CIN3+ determined by a combination of current results and past history (including unknown history).
- The same current test results may yield different management recommendations depending on the history of recent past test results.
- Equal management for equal risk concept developed for 2012 guidelines, expanded for 2019
Expedited Treatment (without confirmatory colposcopic biopsy)
Immediate Risk of pre-cancer (CIN 3+)
<25% Level below which colposcopy and biopsy is preferred
≥25-59% Immediate excisional treatment or treatment after colposcopy with biopsy confirmation are acceptable
>60% Immediate excisional treatment is preferred, treatment after colposcopy with biopsy confirmation is acceptable
*Not recommended for patients age <25 and pregnant women
Patients stratified into risk levels
Expedited treatment is preferred for patients at very high risk
- Specific combinations of test results are so high-risk that patients should proceed directly to a diagnostic excisional procedure (LEEP).
- HPV 16+ HSIL in any patient
- HPV-positive HSIL in patients who are underscreened (defined as no screening in more than 5 years)
Expedited treatment is an option for all high-risk results
- Following shared decision-making, LEEP without confirmatory colposcopy with biopsy is an option for:
- HPV+ ASC-H and HPV-negative HSIL
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- HSIL (CIN2, CIN3) on colposcopic biopsy
- Observation preferred if HSIL on biopsy and CIN 2 or CIN 2,3 specified and fertility desired
- HSIL on cytology
- Colposcopic confirmation optional if plan to proceed to excision
- Exception in young women or when fertility desired
- LSIL (CIN1) on biopsy
- If persists for two years
- continued observation also an option
- If persists for two years
- If preceded by cytology report of ASC-H, HSIL, or AGC
- Co-testing in 12 and 24 months or review of cytology, histology, and colposcopy also options
- HSIL (CIN2, CIN3) on colposcopic biopsy
-
- The indications are the same as indications for LEEP, plus:
- Suspected microinvasive squamous carcinoma
- Rule out adenocarcinoma in situ
- Requires deep cylindrical endocervix conization
- Distorted cervical or vaginal anatomy
- Cervix fixed in downward pointing position
- External os obliterated or flush with vaginal apex
- High grade lesion extends deep into canal
- Cone vs LEEP with top hat
-
- HSIL (CIN2, CIN3) begins at squamocolumnar junction
- If colposcopy adequate, squamous lesions do not begin de novo within the endocervical canal
- Most severe area of lesion is usually most central
- Treat the transformation zone (TZ) 360
- Excise circumferentially to a distance at least 2-3 mm beyond width of lesion
- Higher failure rates if treat only the lesion
- Excise to depth of at least 5-7 mm
- 99% of endocervical gland involvement to depth < 5 mm
- HSIL (CIN2, CIN3) begins at squamocolumnar junction
-
LEEP
- Severe cervicitis
- Pregnancy
- Allergy to local anesthetic
- Hemorrhagic disorder/anticoagulant therapy
- Demand type cardiac pacemaker
- Suspected microinvasive or invasive cancer (relative)
- Risk of thermal artifact
- Suspected adenocarcinoma or adenocarcinoma in situ (relative)
- Risk of thermal artifact
CKC
- Severe Cervicitis
- Pregnancy (relative)
- Contraindications to anesthetic
- Hemorrhagic disorder/ anticoagulant therapy
-
- Cutting Current
- High frequency alternating current produces very rapid alteration from positive to negative
- Rapid fluctuation of ions produces heat
- Current arcs
- Steam envelope forms around arcing electrons – helps conduct current
- Electrode held near tissue but never touching tissue
- Loop must be moved continuously to maintain steam envelope
- Stalls if touches tissue
- Coagulation current - short bursts of modulated voltage sine wave current
- Desiccation: Electrode touches tissue
- Dehydrates cells, deeper tissue damage than fulguration
- Use for hemostasis after LEEP or electrosurgical ablation of cervix lesion peripheral to LEEP site
- Fulguration: Arc sprays above tissue
- Lower temperature, less cautery artifact
- Use for hemostasis after LEEP
- Desiccation: Electrode touches tissue
- Blended current - 80% cut: 20% coagulation
- Commonly used instead of pure cutting current
- Acceptable level of cautery artifact
- Better hemostasis than pure cut
- Commonly used instead of pure cutting current
- Cutting Current
-
- Monopolar electrosurgical generator (ESU) with isolated circuitry and monitoring system
- Smoke evacuator
- May be separate or built in
- Return electrode (dispersive pad)
- Active tissue electrode
- Loop and ball electrodes
- Insulated speculum with smoke evacuation port
- Insulated vaginal sidewall retractor often helpful (not shown)
-
- Review Pap and Colposcopy
- Informed consent
- Repeat colposcopy to identify lesion
- Lugols to outline lesion and area of transformation zone to be removed
Anesthesia
- Submucosal intracervical field block
- 1-2% lidocaine with epinephrine or pitressin
- One approach: 5 cc 2% lidocaine with 1:100,000 dilution epinephrine follow with additional 1% or 2% lidocaine without epinephrine
- 1-2% lidocaine with epinephrine or pitressin
- Injected at multiple sites
- Small gauge spinal needle
- Wait several minutes
- Transient tachycardia normal
-
- Second deeper 1cm x 1cm endocervical excision after the initial LEEP excision
- Indications
- Suspected disease in canal above depth of LEEP
- Increased risk of thermal artifact
-
- General or regional anesthesia in operating room
- Identify transformation zone with colposcopy and/or Lugol’s iodine
- Anterior lip of cervix stabilized with tenaculum
- Cervix may be injected lateral to the planned incision with dilute vasopressin 0.5 U/ml or epinephrine solution 1:200,000 for hemostasis
- Stay sutures near level of internal os at 3:00 and 9:00
- 2-0 delayed absorbable sutures
- Hemostatic, useful for traction, may be loosely tied together to hold Surgicel® at conclusion of case
- Using straight or angled scalpel with #11 blade, perform cone shaped excision
- Remove 360o of transformation zone beginning 2-3 mm lateral to lesion
- Remove endocervical canal to sufficient depth remove endocervical disease
- Base excised with curved scissors
- Hemostasis
- Running locking suture (2-0 or 3-0 delayed absorbable) around excised edge
- Alternatively, cautery may be used same as LEEP
- Accessories for hemostasis
- Monsel’s solution
- Surgicel® in cone bed loosely tied in place with stay sutures previously placed at 3:00 and 9:00
-
- Ibuprofen or Tylenol usually sufficient for pain – expect mild cramping
- Back to work one to two days for LEEP, may be 1-2 days longer for CKC
- Patient will have discharge for several days to weeks
- Avoid intercourse X 4 weeks
- Avoid heavy lifting or vigorous exercise X 2 weeks
- RTC or call for heavy bleeding, fever, severe abdominal pain
-
- Bleeding
- Intraoperative blood loss: Cone > LEEP
- Delayed bleeding risk comparable between LEEP and cone
- Stenosis
- More likely with deep excision (>2 cm) or totally endocervical lesion
- Thermal artifact with LEEP
- May obscure margins
- Unintentional burns with LEEP
- Vaginal sidewall
- Under return electrode or alternate ground
- Uncommon with modern generators
- Bleeding
-
LEEP
- Statistically significant increase
- Late preterm births (> 32/34 weeks)
- pPROM
- Low birth weight infants
- No statistically significant increase
- Preterm births (< 32/34 weeks)
- Cesarean section
- NICU admissions
- Perinatal mortality
CKC
- Statistically significant increase
- Late preterm births (> 32/34 weeks)
- Preterm births < 32/34 weeks
- Low birth weight infants
- Cesarean section
No statistically significant increased risk of preterm birth after LEEP compared with women with cervical dysplasia but no excision.
- Statistically significant increase
-
- Retrospective study of 37,142 women treated for CIN
- Compared Cryo, Laser, Cone, LEEP with negative margins
- Recurrence of CIN 2,3 in first 6 yrs after Treatment
- Higher with older age
- Higher with more severe diagnosis at treatment
- CIN 3> CIN 2> CIN 1
- Varies with treatment modality
- Cryo > LASER> LEEP > Cone
- Rate of CIN 2,3 diagnosis after treatment of CIN 3
- Age 30-39: CKC 6.3% LEEP 9.6%
- Age 40-49: CKC 8.5% LEEP 12.9%
- Retrospective study of 37,142 women treated for CIN
-
- Meta analysis of 25 studies
- RR of CIN 2+ after incomplete excision 6.09 (CI 3.87-9.60) compared with complete excision
- Frequency of post-treatment CIN 2+
- Clear margins - 3%
- Margins involved - 18%
- Meta analysis of 25 studies
-
Initial intensive surveillance after excision for HSIL:
- If negative margins for CIN2+
- HPV-based testing at 6 months is preferred followed by annual HPV or cotesting until 3 consecutive negative test results.
- If any test positive colposcopy with endocervical sampling
- If positive margins for CIN2+
- Repeat excision or observation is acceptable if >25-years old and not concerned about potential effect on future pregnancy
- If re-excision is not feasible and completed childbearing, hysterectomy is acceptable
- HPV-based testing at 6 months is preferred if observation. Colposcopy + ECC at 6 months is also acceptable. Followed by annual HPV or contesting until 3 consecutive negative test results.
- Long term follow up after excision for HSIL:
- Continued surveillance with HPV testing or co-testing at 3-year intervals for at least 25 years following treatment of high-grade histology (HSIL, CIN 2, CIN 3, or AIS).
- Continued surveillance at 3-year intervals beyond 25 years is acceptable as long as the patient’s life expectancy and ability to be screened are not significantly compromised by serious health issues.
- New evidence indicates that risk remains elevated for at least 25 years, with no evidence that treated patients ever return to risk levels compatible with 5-year intervals for screening
- If negative margins for CIN2+
Author
- Alan G. Waxman, MD, MPH, Department of Obstetrics & Gynecology, University of New Mexico
References
- Kyrgiou M, Koliopoulos G, Martin-Hirsch P et al. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: Systematic review and meta-analysis. Lancet Feb 2006; 367, 489-498.
- Conner SN, Frey HA, Cahill AG, et al. Loop electrosurgical excision procedure and risk of preterm birth: a systematic review and meta-analysis. Obstet Gynecol;123:752-61.
- Melnikow J, McGahan C, Sawaya, et al. Cervical intraepithelial neoplasia outcomes after treatment: Long-term follow-up from the British Columbia cohort study. JNCI 2009;101(10):721-728.
- Arbyn M, Kyrgiou M, Simoens C et al. Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: meta-analysis. BMJ 2008;337:1-11.
- Ghaem-Maghami S, Sagi S, Majeed G, et al Incomplete excision of cervical intraepithelial neoplasia and risk of treatment failure: a meta-analysis. Lancet Oncol. 2007;8:985-93.
- Mathevet P, Dargent D, Roy M, Beau G. A randomized prospective study comparing three techniques of conization: cold knife, laser, and LEEP. Gynecol Oncol. 1994 Aug;54(2):175-9.
- Massad LS, Einstein MH, Huh WK, et al . 2012 Updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis 2013;17(5S):S1-17.
- Darragh et. al. J. Low Genit Tract Dis 2012;16:205-42.
- Perkins RB, Guido RS, Castle PE, et al. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020;24(2):102-131.
- Teoh D, Musa F, Salani R, Huh W, Jimenez E. Diagnosis and Management of Adenocarcinoma in Situ: A Society of Gynecologic Oncology Evidence-Based Review and Recommendations. Obstet Gynecol. 2020;135(4):869-878.
Developed in association with ASCCP, the society for lower genital tract disorders.
The CREOG Surgical Skills Task Force created this simulation as part of a standardized surgical skills curriculum for use in training residents in obstetrics and gynecology.