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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MJCamargo, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00995020
First received: June 16, 2009
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ 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 Intervention Phase
Cervical Intraepithelial Neoplasia
 Procedure: Straight Wire Excision of Transformation Zone
Procedure: Large Loop Excision of Transformation Zone (cone biopsy)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Endocervical Margin Not Free of Disease. [ Time Frame: 3 months after the surgery is performed. ] [ Designated as safety issue: No ]
    Primary outcome is the incidence of incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.


Secondary Outcome Measures:
  • Time Spent to Perform the Procedure [ Time Frame: Time spent from randomization to complete the procedure ] [ Designated as safety issue: No ]
    Time was recorded from insertion until removal of the vaginal speculum.


Enrollment: 103
Study Start Date: November 1999
Study Completion Date: December 2010
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SWETZ 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 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

Detailed Description:

The treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone (TZ). When the TZ 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 ( also called LEEP), is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin with the objective to acquire 20-25 mm up the canal.
  2. The experimental intervention is SWETZ, 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 is used as a knife, fashioning a cone with desired dimensions.

This technique may be able to excise the endocervical TZ 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 biopsy in the management of endocervical pre-invasive disease.

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: MJCamargo, PHD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00995020     History of Changes
Other Study ID Numbers: 522/99
Study First Received: June 16, 2009
Results First Received: October 15, 2012
Last Updated: October 15, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Oswaldo Cruz Foundation:
Cone biopsy
Conization
LEEP
Loop electrosurgical excisional procedures
LLETZ
Large Loop Excision of Transformation Zone
 NETZ
Needle Excision of Transformation Zone
SWETZ
Straight Wire Excision of Transformation Zone
Electrosurgery

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

ClinicalTrials.gov processed this record on May 22, 2013