Cervical Intraepithelial NeoplasiaPhase 3NCT00995020

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

A Phase 3 study testing Straight Wire Excision of Transformation Zone and Large Loop Excision of Transformation Zone (cone biopsy) in people with Cervical Intraepithelial Neoplasia, run by Oswaldo Cruz Foundation at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Cervical Intraepithelial Neoplasia
What is being tested?: Straight Wire Excision of Transformation Zone and Large Loop Excision of Transformation Zone (cone biopsy)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 2 sitesBrazil
Study dates: Nov 1999to Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

Instituto Fernandes Figueira - Oswaldo Cruz Foundation
Rio de Janeiro, Rio de Janeiro, 22250-020
Instituto Fernandes Figueira
Rio de Janeiro, Rio de Janeiro

Other trials in Brazil

About this study

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

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.

Read the 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.

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.

Conditions: Cervical Intraepithelial Neoplasia
Being tested: Straight Wire Excision of Transformation Zone, Large Loop Excision of Transformation Zone (cone biopsy)
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
Medical subject headings: Uterine Cervical Dysplasia, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Straight Wire Excision of Transformation ZoneProcedure or surgery
Also called NETZ - Needle 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)Procedure or surgery
Also called LEEP - Loop Electrosurgical Procedure
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.

Study groups in NCT00995020
Study group	Role	What they receive
SWETZ	Experimental	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.. Receives: Procedure: Straight Wire Excision of Transformation Zone
LLETZ cone	Active comparator	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 . Receives: Procedure: Large Loop Excision of Transformation Zone (cone biopsy)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months after the surgery is performed.

Secondary outcomes (1)

Time Spent to Perform the Procedure
Time was recorded from insertion until removal of the vaginal speculum.
Measured: Time spent from randomization to complete the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 1999Dec 2010

First posted14 Oct 2009 (estimated)
Study startNov 1999
Primary completionDec 2004
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00995020
Sponsor's protocol ID: 522/99
Status last verified: Jun 2015
First submitted: 16 Jun 2009
Last updated: 10 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25516462

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cervical Intraepithelial Neoplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.
ClinicalTrials.gov ID: NCT00995020
Acronym / sponsor ID: 522/99
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Oswaldo Cruz FoundationUniversity, hospital or other
Study start: Nov 1999
Primary completion: Dec 2004 (actual)
Study completion: Dec 2010 (actual)
First posted: 14 Oct 2009 (estimated)
Results: Posted 15 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SWETZ	Experimental	Procedure: Straight Wire Excision of Transformation ZoneThe 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..
LLETZ cone	Active comparator	Procedure: Large Loop Excision of Transformation Zone (cone biopsy)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 .

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Straight Wire Excision of Transformation ZoneAlso: NETZ - Needle Excision Of Transformation ZoneStraight 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.	Procedure or surgery	SWETZ
Large Loop Excision of Transformation Zone (cone biopsy)Also: LEEP - Loop Electrosurgical ProcedureLLETZ 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.	Procedure or surgery	LLETZ cone

Primary outcome

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.

1 secondary outcome

Time Spent to Perform the Procedure
Time frame: Time spent from randomization to complete the procedure

Results and safety

Results posted to the registry on 15 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SWETZ - Straight Wire Excision of the Transformation Zone	51	48
LLETZ Cone: Large Loop Excision of Transformation Zone - Cone	52	45

Primary outcome: Endocervical Margin Not Free of Disease.

Time frame: 3 months after the surgery is performed.. Number. Unit: participants

Measure	SWETZ n = 51	LLETZ Cone n = 52
Value	8	10

Population analysed: All data were analysed bu intention to treat.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SWETZ - Straight Wire Excision of the Transformation Zone	0 of 51 (0%)	0 of 51 (0%)	Not reported
LLETZ Cone - Loop Excision of TZ Cone Biopsy	0 of 52 (0%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25516462Camargo 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

WALTER PRENDIVILLE, PhD study director

British Society of Colposcopy

WALTER PRENDIVILLE, PhD study director

International Federation of Cervical Pathology and Colposcopy

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endocervical Margin Not Free of Disease. (time frame: 3 months after the surgery is performed.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00995020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.