Clinical trial NCT00995020: Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion
Official title: A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Cone biopsy
Conization
Loop electrosurgical excisional procedures
Large Loop Excision of Transformation Zone
Needle Excision of Transformation Zone
Straight Wire Excision of Transformation Zone
Electrosurgery
Lead sponsor: Oswaldo Cruz Foundation
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 103
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Endocervical Margin Not Free of Disease.
timeFrame: 3 months after the surgery is performed.
Secondary outcomes:
measure: Time Spent to Perform the Procedure
timeFrame: Time spent from randomization to complete the procedure
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Fernandes Figueira - Oswaldo Cruz Foundation
city: Rio de Janeiro
country: Brazil
facility: Instituto Fernandes Figueira
Study officials:
affiliation: British Society of Colposcopy
name: WALTER PRENDIVILLE, PhD
role: STUDY_DIRECTOR
affiliation: International Federation of Cervical Pathology and Colposcopy
name: WALTER PRENDIVILLE, PhD
role: STUDY_DIRECTOR
References:
citation: Camargo MJ, Russomano FB, Tristao MA, Huf G, Prendiville W. Large loop versus straight-wire excision of the transformation zone for treatment of cervical intraepithelial neoplasia: a randomised controlled trial of electrosurgical techniques. BJOG. 2015 Mar;122(4):552-7. doi: 10.1111/1471-0528.13200. Epub 2014 Dec 17.