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

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ClinicalTrials.gov Identifier: NCT00995020
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : November 15, 2012
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
MJCamargo, Oswaldo Cruz Foundation

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.


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Procedure: Straight Wire Excision of Transformation Zone Procedure: Large Loop Excision of Transformation Zone (cone biopsy) Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.
Study Start Date : November 1999
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: SWETZ
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..
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.
Other Name: NETZ - Needle Excision Of Transformation Zone

Active Comparator: LLETZ cone
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 .
Procedure: 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.
Other Name: LEEP - Loop Electrosurgical Procedure




Primary Outcome Measures :
  1. Endocervical Margin Not Free of Disease. [ Time Frame: 3 months after the surgery is performed. ]
    Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.


Secondary Outcome Measures :
  1. Time Spent to Perform the Procedure [ Time Frame: Time spent from randomization to complete the procedure ]
    Time was recorded from insertion until removal of the vaginal speculum.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995020


Locations
Brazil
Instituto Fernandes Figueira - Oswaldo Cruz Foundation
Rio de Janeiro, Brazil, 22250-020
Instituto Fernandes Figueira
Rio de Janeiro, Brazil
Sponsors and Collaborators
Oswaldo Cruz Foundation
Investigators
Study Director: WALTER PRENDIVILLE, PhD British Society of Colposcopy
Study Director: WALTER PRENDIVILLE, PhD International Federation of Cervical Pathology and Colposcopy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MJCamargo, PHD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00995020     History of Changes
Obsolete Identifiers: NCT01733225
Other Study ID Numbers: 522/99
First Posted: October 14, 2009    Key Record Dates
Results First Posted: November 15, 2012
Last Update Posted: July 10, 2015
Last Verified: June 2015

Keywords provided by MJCamargo, Oswaldo Cruz Foundation:
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

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms