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

NCT00995020 | Completed Phase 3 Results

• 1 other identifier: 522/99
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Time Spent to Perform the Procedure

  Time spent from randomization to complete the procedure

Study Arms (2)

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..

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 .

Procedure: Large Loop Excision of Transformation Zone (cone biopsy)

Interventions

Straight Wire Excision of Transformation Zone PROCEDURE

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.

Also known as: NETZ - Needle Excision Of Transformation Zone

SWETZ

Large Loop Excision of Transformation Zone (cone biopsy) 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.

Also known as: LEEP - Loop Electrosurgical Procedure

LLETZ cone

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (2)

Instituto Fernandes Figueira - Oswaldo Cruz Foundation

Rio de Janeiro, Rio de Janeiro, 22250-020, Brazil

Location

Instituto Fernandes Figueira

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25516462 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Hyperthermia

Interventions

Conization

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Investigator: MJCamargo [Camargo Maria José] Official Title: PHD
• Organization: Affiliation: Oswaldo Cruz Foundation

mariaj.camargo@hotmail.com

00552199777009

Study Officials

• WALTER PRENDIVILLE, PhD

  British Society of Colposcopy

  STUDY DIRECTOR

• WALTER PRENDIVILLE, PhD

  International Federation of Cervical Pathology and Colposcopy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: October 14, 2009
• Study Start: November 1, 1999
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2010
• Last Updated: July 10, 2015
• Results First Posted: November 15, 2012

Record last verified: 2015-06

Locations

BR (2)