Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion
Study Details
Study Description
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 |
|---|---|---|
|
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.
-
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
Arms and Interventions
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Endocervical Margin Not Free of Disease. [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
- Time Spent to Perform the Procedure [Time spent from randomization to complete the procedure]
Time was recorded from insertion until removal of the vaginal speculum.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto Fernandes Figueira - Oswaldo Cruz Foundation | Rio de Janeiro | Brazil | 22250-020 | |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 522/99
- NCT01733225
Study Results
Participant Flow
| Recruitment Details | Between November 1999 and December 2004, patients were assessed for eligibility, the great majority in Rio de Janeiro. |
|---|---|
| Pre-assignment Detail | 127 women were eligible for both arms: 5 refused to participate, 19 did not meet inclusion criteria. |
| Arm/Group Title | SWETZ - Straight Wire Excision of the Transformation Zone | LLETZ Cone: Large Loop Excision of Transformation Zone - Cone |
|---|---|---|
| Arm/Group Description | The experimental intervention was SWETZ (straight wire excision of the transformation zone), which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium. | The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), was 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 (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium. |
| Period Title: Overall Study | ||
| STARTED | 51 | 52 |
| COMPLETED | 48 | 45 |
| NOT COMPLETED | 3 | 7 |
Baseline Characteristics
| Arm/Group Title | SWETZ - Straight Wire Excision of the Transformation Zone | LLETZ Cone - Loop Excision of TZ Cone Biopsy | Total |
|---|---|---|---|
| Arm/Group Description | The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium. | The standard procedure, LLETZ - cone, was 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 just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium. | Total of all reporting groups |
| Overall Participants | 51 | 52 | 103 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
43.7
(9.9)
|
45.6
(11.5)
|
44.6
(10.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
51
100%
|
52
100%
|
103
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
51
100%
|
52
100%
|
103
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Brazil |
46
90.2%
|
46
88.5%
|
92
89.3%
|
| Ireland |
5
9.8%
|
6
11.5%
|
11
10.7%
|
Outcome Measures
| Title | Endocervical Margin Not Free of Disease. |
|---|---|
| Description | Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically. |
| Time Frame | 3 months after the surgery is performed. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All data were analysed bu intention to treat. |
| Arm/Group Title | SWETZ | LLETZ Cone |
|---|---|---|
| Arm/Group Description | SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition. | LLETZ cone,the standard procedure 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 just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition. |
| Measure Participants | 51 | 52 |
| Number [participants] |
8
15.7%
|
10
19.2%
|
| Title | Time Spent to Perform the Procedure |
|---|---|
| Description | Time was recorded from insertion until removal of the vaginal speculum. |
| Time Frame | Time spent from randomization to complete the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | LLETZ - Cone | SWETZ |
|---|---|---|
| Arm/Group Description | LLETZ - cone was 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 just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium. | SWETZ uses a 1cm straight 0.20mm wire to fashion a similar excision. |
| Measure Participants | 52 | 51 |
| Mean (Standard Deviation) [minuts] |
13.5
(5.3)
|
23.2
(8.1)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SWETZ - Straight Wire Excision of the Transformation Zone | LLETZ Cone - Loop Excision of TZ Cone Biopsy | ||
| Arm/Group Description | The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium. | The standard procedure, LLETZ - cone, was 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 just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium. | ||
All Cause Mortality |
||||
| SWETZ - Straight Wire Excision of the Transformation Zone | LLETZ Cone - Loop Excision of TZ Cone Biopsy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SWETZ - Straight Wire Excision of the Transformation Zone | LLETZ Cone - Loop Excision of TZ Cone Biopsy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/51 (0%) | 0/52 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| SWETZ - Straight Wire Excision of the Transformation Zone | LLETZ Cone - Loop Excision of TZ Cone Biopsy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/51 (0%) | 0/52 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Investigator: MJCamargo [Camargo Maria José] Official Title: PHD |
|---|---|
| Organization | Affiliation: Oswaldo Cruz Foundation |
| Phone | 00552199777009 |
| mariaj.camargo@hotmail.com |
- 522/99
- NCT01733225