Cold Knife Cone Case File

Cold Knife Cone Case File

Eugene C. Toy, MD, Konrad P. Harms, MD, Keith O. Reeves, MD, Cristo Papasakelariou, MD, FACOG

Case 40

A 30-year-old African American G1P1001 woman presents for her annual well-woman examination. The patient denies any complaints at this time. She is happily married, and she and her husband desire to conceive another child in the next year. A complete history and physical examination is performed and a Pap smear is obtained. The patient has been receiving annual Pap smears since 21 years of age and denies any history of abnormal Pap smears.

The results of the Pap smear show HSIL. The patient returns to the office and undergoes colposcopy. There is one acetowhite focal lesion present at the squamocolumnar junction extending from the 5 to 7 o’clock position of the exocervix. The colposcopic impression is adequate, with moderate-to-severe dysplasia. A punch biopsy of the lesion is taken and an ECC is performed. The results of the biopsy show carcinoma in situ, can’t rule out microinvasion, while the ECC is negative. Options were discussed with the patient and she desires conservative management.

➤ What is your next step?

➤ What are the indications for diagnostic excisional procedure?

➤ What are potential complications of this procedure?

ANSWERS TO CASE 40:

Cold Knife Cone

Summary: This is a 30-year-old G1P1001 woman with a history of carcinoma in situ (CIS) of the cervix diagnosed by colposcopically directed biopsy. The patient desires future fertility; therefore, she would like to be managed conservatively.

➤ Next step: Diagnostic and therapeutic cold knife conization (CKC) of the cervix to rule out microinvasion.

➤ Indications for diagnostic excisional procedure: Inadequate colposcopy, two-grade Pap-colposcopy discrepancy, suspicion of microinvasion, endocervical involvement, adenocarcinoma in situ, treatment of persistent or recurrent CIN after failure of LEEP or ablation.

➤ Potential complications: Early and late postoperative bleeding, infection, cervical stenosis, cervical incompetence, infertility.

ANALYSIS

Objectives

1. List the indications for a CKC.
2. Describe the technique of CKC.
3. Describe the long-term follow-up after CKC.
4. List the short- and long-term complications of CKC and effects on future childbearing.

Considerations

This is a 30-year-old G1P1001 African American woman with a newly diagnosed CIS of the cervix. The patient desires future fertility and wishes to conceive another child in the next year. After counseling, the patient agrees to conservative management in the form of CKC. Patients with high-grade cervical lesions can be managed conservatively until childbearing wishes are done. For this patient, the excision is not only performed for possible treatment but more importantly to rule out microinvasive disease.

In general, high-grade lesions of the cervix are managed with one of the excisional procedures (LEEP, CKC, or laser conization). It has been shown that 2% to 3% of patients with high-grade dysplasia actually demonstrate unrecognized CIS or even invasive cancer. A pathologist cannot make a final diagnosis of microinvasive cervical cancer on punch biopsy or ECC. It is essential that the pathologist examines a large, well-oriented tissue specimen that is in one piece. In addition, it is important for the margins to be clearly seen to ensure diagnosis and possible treatment. Excisional techniques include LEEP, CKC, and CO2 laser. An advantage of a CKC is that the specimen has very clear well-defined margins. When excision is performed by the LEEP or laser, coagulation artifact along the margin may be present in 3.3% to 51% of cases.

APPROACH TO

Cold Knife Conization

DEFINITIONS

CONIZATION: A large biopsy of the central cervix for the diagnosis or treatment of cervical dysplasia.

COLD KNIFE CONIZATION: A conization of the cervix performed with a scalpel.

MICROINVASIVE CERVICAL CANCER: A small cervical carcinoma detected by microscope only (stage IA cervical cancer).

CLINICAL APPROACH

Indications

There are four clinical scenarios in which diagnostic excisional procedure should be performed. These include:

1. An inadequate colposcopy (entire lesion or squamocolumnar junction [SCJ] not visualized)
2. Suspicion of microinvasion
3. Greater than or equal to two-grade discrepancy between Pap smear and colposcopy/biopsy
4. Endocervical involvement (ECC +)

Either a LEEP or CKC may be performed to obtain a cone biopsy specimen, but keep in mind that coagulation artifact from some LEEP specimens may make interpretation of the surgical margins difficult. A CKC is also the preferred treatment of adenocarcinoma in situ and treatment of persistent or recurrent CIN after failure of LEEP or ablation.

Technique

The traditional CKC (Figures 40–1 and 40–2) has been used for many years in the treatment of CIN. In the past, hot cautery was used to perform the conization of an inflamed, hypertrophic, chronically infected cervix. However, for the excision of CIN, a standard surgical scalpel was more appropriate. Thus, the term “cold knife” was introduced to differentiate these two procedures.

A CKC is generally performed in the OR under anesthesia. The patient is placed supine in the dorsal lithotomy position. After examination under anesthesia, the patient is prepped and draped in sterile fashion. A weighted speculum is placed in the vagina. Lugol solution is placed on the cervix to delineate the

Figure 40–1. Conization of the cervix shows a narrow and deep specimen for endocervical disease, and a more shallow and wide specimen for suspected ectocervical disease. (Reproduced, with permission, from Schorge JO, Schaffer JI, Halvorson LM, et al. Williams Gynecology. New York: McGraw-Hill, 2008:893.)

Figure 40–2. Conization of the cervix.Sutures are placed at 3 and 9 o’clock positions of the cervix for hemostasis and also stabilization of the cervix. An angled blade is used to incise the cervix to give a cone biopsy. (Reproduced, with permission, from Schorge JO, Schaffer JI, Halvorson LM, et al. Williams Gynecology. New York: McGraw- Hill, 2008:892.)

margins of the transformation zone and identify the areas of dysplasia. The cervix is then injected with a vasoconstrictive agent to help decrease blood loss. Approximately 1.5 cc of a mixture of a local anesthetic (lidocaine) with 1:100,000 epinephrine is injected directly into four quadrants of the cervix, that is, 2, 4, 8, and 10 o’clock. A total of 9 to 10 cc is injected and should cause “ballooning” and blanching of the cervix. Because acute hypertension may be caused by this drug, inform the anesthesiologist of its use before injection. Lateral hemostatic sutures (stay sutures), consisting of 2-0 Vicryl or 2-0 Chromic may then be placed at the 3 and 9 o’clock positions of the cervix to ligate the cervical branches of the uterine artery and as a way to apply traction to the cervix. Studies have subsequently shown no benefit to deep lateral sutures in helping reduce blood lossm.1,2

With the lesion demarcated with Lugol solution, an angled scalpel is used to make a circumferential incision around the cervix, with care taken to encompass the entire transformation zone. The cervix can be stabilized with a tenaculum or the lateral stay sutures. A no. 11 scalpel blade is commonly used; other choices include a larger no. 10 blade or a smaller no. 15 blade. As the cone is cut, it is retracted to the opposite side to provide visibility at the base of the incision. The preferred specimen is a cylindrical cone that runs parallel and symmetric to the endocervical canal, includes the deep glands of the canal, and has its apex in the canal. The intact cone should then be tagged with suture at 12 or 6 o’clock so that the pathologist can orient any positive margins or foci of invasive cancer.

The surgeon can then use electrocautery to coagulate the cervical cone bed. Alternatively, the tissue between the ectocervical and endocervical surgical margin can be reapproximated in a continuous locking fashion. Monsel solution can also be placed if needed.

Follow-up

Posttreatment, patients should receive either cytology with colposcopy or cytology only at 6-month intervals. After two negative results, the patient may proceed with routine screening, for at least 20 years following CKC. If the patient has an abnormal Pap smear at any time, a colposcopy with endocervical curettage must be performed. An alternative posttreatment plan is HPV testing at 6 to 12 months following treatment. Patients who are highrisk HPV positive at testing should proceed with colposcopy/ECC. Patients who are high-risk HPV negative can proceed with routine testing, for at least 20 years following CKC.

CKC is usually considered the definitive treatment of CIN if the cone has encompassed the entire extent of the epithelial change; in other words, the epithelium is clear of disease at the surgical margins. One study evaluated the long-term outcome of patients with CIN 3/CIS after CKC with involved margins.3 Of the 969 patients with positive margins, 390 patients were followed expectantly for a mean of 19 (range 6-30) years. Results showed a 22% incidence of persistent or recurrent disease in these patients, with 1.3% developing microinvasive cancer and 1% patients with a stage IB lesion. On the other hand, after incomplete excision of CIN 3, most patients did not develop persistent or recurrent disease. This is probably because of the effect of diathermy on the cut cervix after removal of the cone and the inflammatory response associated with wound healing. Dysplastic or malignant epithelium within the inner zone of necrosis and an outer zone of white cell infiltration appears to be eradicated after CKC. Only lesions outside these zones can persist, regress, or progress. The findings suggested that expectant management is reasonable for patients with CIN 3 and positive margins after CKC, provided that careful follow-up is available, particularly during the first year.

Of note, a recent retrospective study showed that compared with office LEEP procedures, CKC patients were significantly more compliant with follow- up appointments.4 The authors concluded that because LEEP is a less invasive in-office procedure, it may convey to patients the idea that their condition is less severe.

Complications

Cold knife conization is associated with a relatively high complication rate. Short- and long-term complications include early and late postoperative hemorrhage, infection, cervical stenosis, and cervical incompetence. Perioperative and postoperative hemorrhage, the most common complication, generally occurs in 10% to 20% of cases. Hemorrhage is described as early if it occurs within the first 24 hours of surgery. Late hemorrhage typically occurs 10 to 21 days after surgery when the sutures dissolve. Intracervical vasopressors and topical thrombotic agents (Monsel solution) are shown to significantly decrease estimated blood loss, but lateral hemostatic sutures have not been shown to have this effect. There are conflicting results regarding the superior method for obtaining hemostasis of the cervical cone bed. Some studies advocate that electrocautery is more effective in decreasing estimated blood loss, while others insist a continuous suture is the most hemostatic way to close the cone bed.

Cold knife conization, as are all excisional techniques, is associated with a roughly doubled rate of preterm labor (PTL) and delivery.5 The size of the cone is directly related to the risk of preterm labor. CKC also increases the risk of preterm premature rupture of membranes (PPROM). Two mechanisms have been proposed to account for a higher rate of preterm birth and PPROM after conization. One reason seems to be the disruption of cervical glands and reduced secretion of mucus after removal of cervical tissue. This might result in an impaired defense mechanism against microbial colonization in the cervix, which could facilitate ascending infections and lead to a higher rate of PROM. Another possibility is when part of the connective tissue of the cervix is removed with CKC; this leads to cervical fragility during pregnancy. There is a different collagen composition of the original cervical tissue compared to that of the cervical scar.

Cervical stenosis occurs in about 3% of patients. This is more common in patients who are not having regular menstrual periods. This condition may result in infertility, hematometra, and dysmenorrhea. Data also indicate a slight increase in the incidence of symptomatic cervical tears during vaginal delivery, requiring surgical repair because of postpartum bleeding.

Young women with need for conization should be informed about potential complications in subsequent pregnancies. In addition, closer surveillance, including measurement of the cervical length, might be useful, and information about a prior conization should be available for the obstetrician.

Comprehension Questions

40.1 A 28-year-old G3P3003 woman presents to the office for preoperative evaluation for planned CKC. She asks the physician what risks are associated with this procedure. Which of the following is the most common complication from CKC?

A. Preterm labor

B. Cervical stenosis

C. Postoperative hemorrhage

D. Cervical incompetence

E. Infection

40.2 A 26-year-old G2P2002 woman who underwent CKC for CIN 3 is found to have a positive margin on pathologic evaluation of the specimen. What is the best next step?

A. Repeat CKC immediately.

B. Repeat CKC in 6 weeks, after healing takes place.

C. Perform a Pap smear and colposcopy in 6 weeks after healing takes place.

D. Perform a Pap smear and colposcopy in 6 months. 

40.3 A 33-year-old G3P0202 woman at 9 weeks’ gestation presents for an initial OB appointment. The patient gives a history of CKC at 23 years of age with no abnormal Pap smears since that time. Her obstetric history is significant for preterm labor and delivery at 32 weeks’ gestational age and again at 34 weeks. Which of the following is the best next step in management?

A. Placement of abdominal cerclage

B. Placement of a cervical cerclage using the McDonald technique

C. Measurement of cervical length by sonogram

D. Recommendation of strict bed rest

ANSWERS

40.1 C. Early (within 24 hours of surgery) and late (24 hours or more after surgery) postoperative hemorrhage complicates 10% to 20% of cases of CKC. All of the other choices are complications of CKC, but these occur less often. Two options for controlling hemorrhage include placement of a vaginal pack or closure of the cervical bed with a continuous locking suture.

40.2 D. Re-exision is not necessary for patients with a positive margin following CKC. Seventy-eight percent or more of patients with involved margins are free of disease at follow-up. The diathermy effect and inflammatory response seems to eradicate the remaining dysplastic cells. These patients should proceed with routine follow-up at 6 months with Pap smear and/or colposcopy or high-risk HPV testing.

40.3 C. Following CKC, patients are at increased risk of PTL and PROM. Given this patient’s history of two preterm deliveries, cervical incompetence due to previous CKC is a possibility. The next best step in management would be sonographic measurement of her cervical length. Patients with a cervical length of shorter than 2.5 cm are at a higher risk of PTL. An elective McDonald cerclage may be an option for this patient, but it is not the immediate next step; in addition, cerclage placement is preferable at about 12 to 14 weeks’ gestational age. Bed rest and abdominal cerclage are not indicated in this situation.

Clinical Pearls

See Table 1-2 for definition of level of evidence and strength of recommendation

➤ Excisional techniques are recommended in high-grade lesions because excision provides histological confirmation that invasive cancer is not present (Level A).

➤ For patients with positive margins following CKC for the treatment of CIN 2 or 3, re-excision is not necessary. Patients should be followed at 6-month intervals with cytology and/or colposcopy or high-risk HPV testing (Level B).

➤ All of the excisional procedures to treat CIN present similar pregnancyrelated morbidity, without apparent neonatal morbidity (Level B).

REFERENCES

1. Kamat AA, Kramer P, Soisson AP. Superiority of electrocautery over the suture method for achieving cervical cone bed hemostasis. Obstet Gynecol. 2003;102;726-730. 

2. Dane C, Dane B, Cetin A, Erginbas M. Haemostasis after cold knife conization: a randomized prospective trial comparing cerclage suture versus electrocauterization. Aust N Z J Obstet Gynaecol. 2008;48:343-347. 

3. Reich O, Lahousen M, Pickel H, et al. Cervical intraepithelial neoplasia III: longterm outcome after cold-knife conization with involved margins. Obstet Gynecol. 2002;99:193-196. 

4. Wright TC Jr, Massad LS, Dunton CJ, et al. 2206 American Society for Colposcopy and Cervical Pathology-Sponsored Concensus Conference. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol. 2007;197:346-355. 

5. Klaritsch P, Reich O, Giuliani A, et al. Delivery outcome after cold-knife conization of the uterine cervix. Gynecol Oncol. 2006;103:604-607. 

6. Greenspan D, Faubion M, Coonrod D, et al. Compliance after loop electrosurgical excision procedure or cold knife cone biopsy. Obstet Gynecol. 2007;110:675-680. 

7. Kyrgiou G, Martin-Hirsch P, Arbyn M, et al. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Lancet. 2006;367:489-498. 

8. Mathevet P, Chemali E, Roy M, et al. Long-term outcome of a randomized study comparing three techniques of conization: cold knife, laser, and LEEP. Eur J Obstet Gynecol Reprod Bio. 2003;106:214-218. 

9. Reich O, Pickel H, Lahousen M, et al. Cervical intraepithelial neoplasia III: longterm outcome after cold-knife conization with clear margins. Obstet Gynecol. 2001;97:428-430. 

10. Rock J, Jones H. Cervical cancer precursors and their management. In: Rock J, Jones H. ed. Te Linde’s Operative Gynecology. 10th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2008:1208-1225.

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