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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995020
• Other study ID #: 522/99
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2009
• Last updated: June 14, 2015
• Start date: November 1999
• Est. completion date: December 2010

Study information

• Verified date: June 2015
• Source: Oswaldo Cruz Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01733225

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2010
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

Procedure:
• Straight Wire Excision of Transformation Zone
Straight wire excision of transformation zone is a electrosurgical conization method,which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
• Large Loop Excision of Transformation Zone (cone biopsy)
LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20-25 mm depth. The loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin.

Locations

Country	Name	City	State
Brazil	Instituto Fernandes Figueira	Rio de Janeiro
Brazil	Instituto Fernandes Figueira - Oswaldo Cruz Foundation	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Oswaldo Cruz Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endocervical Margin Not Free of Disease.	Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.	3 months after the surgery is performed.	No
Secondary	Time Spent to Perform the Procedure	Time was recorded from insertion until removal of the vaginal speculum.	Time spent from randomization to complete the procedure	No