Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion

Oswaldo Cruz Foundation

Status and phase: Completed; Phase 3

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Procedure: Straight Wire Excision of Transformation Zone; Procedure: Large Loop Excision of Transformation Zone (cone biopsy)

Study type: Interventional

Funder types: Other

Identifiers

NCT00995020

522/99

Details and patient eligibility

About

The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.

SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to LLETZ cone, which is performed with a large loop electrode.

Full description

The treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone . When the transformation zone contains squamous precancer and is completely ectocervical and therefore full visible, excision or destruction is an effective and relatively straightforward therapeutic entity. However in a small proportion of women a cone biopsy is necessary. A cone biopsy often requires the excision of 20-30 mms of endocervical canal.

Interventions.

The standard procedure, LLETZ - cone (Large Loop Excision of Transformation Zone cone biopsy), is performed with a large loop electrode of 20-25 mm depth. The activated loop was applied to the cervix outside the lateral margin of transformation zone and brought slowly to the controlateral margin with the objective to acquire 20-25 mm up the canal. The experimental intervention is SWETZ (Straight Wire Excision of Transformation Zone), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease. The activated wire was used as a knife, fashioning a cone with desired dimensions.

This technique may be able to excise the endocervical transformation zone with a lower rate of morbidity and incomplete excision rate than LLETZ cone biopsy.

The hypothesis to be tested in this trial is that SWETZ is superior to LLETZ cone in the management of endocervical pre-invasive disease.

Enrollment: 103 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Incompletely visible transformation zone in women with High grade Squamous Intraepithelial Lesion (HSIL)
• Suspicion of microinvasive carcinoma or occult invasive carcinoma
• Suspicion of glandular disease

Exclusion criteria

• Pregnancy
• Coagulation disorders
• Cervicitis were present
• Refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

103 participants in 2 patient groups

SWETZ

Experimental group

Description:

The intervention administered in this arm is the straight wire excision of the transformation zone, a electrosurgical method to perform a cone biopsy using a 1 cm straight wire of 0.20 mm wire. The activated wire is used in much the same way as a cold knife or laser beam fashioning the surgical specimen to achieve two centimeters cm at cervical canal..

Treatment:

Procedure: Straight Wire Excision of Transformation Zone

LLETZ cone

Active Comparator group

Description:

The intervention administered in this arm is the large loop excision of transformation zone as a cone biopsy, performed using a large loop electrode of 2 cm depth, applied to the cervix to achieving two centimeters at cervical canal .

Treatment:

Procedure: Large Loop Excision of Transformation Zone (cone biopsy)