Cervical Excision Procedures: Loop Electrosurgical Excision Procedure and Cold Knife Cone

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

• 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 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

• 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

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
• Blended current - 80% cut: 20% coagulation
  • Commonly used instead of pure cutting current
    • Acceptable level of cautery artifact
    • Better hemostasis than pure cut

1. Monopolar electrosurgical generator (ESU) with isolated circuitry and monitoring system
2. Smoke evacuator
   • May be separate or built in
3. Return electrode (dispersive pad)
4. Active tissue electrode
   • Loop and ball electrodes
5. Insulated speculum with smoke evacuation port
6. 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
• 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

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.

• 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%

• 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%

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