JOURNAL ONKOLOGIE – STUDIE

Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04772937

Studienbeginn:
Juni 2021

Letztes Update:
26.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Uterine Cervical Dysplasia, Hyperplasia

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ruhr University of Bochum

Collaborator:
-

Studienleiter

Clemens B Tempfer, MD, MBA
Principal Investigator
Ruhr-Universität Bochum / Marien Hospital Herne

Kontakt

Clemens B Temfper, MD, MBA
Kontakt:
Phone: +492323499
Phone (ext.): 1801
E-Mail: clemens.tempfer@rub.de» Kontaktdaten anzeigen

Günther A Rezniczek, PhD
Kontakt:
Phone: +492323499
Phone (ext.): 1058
E-Mail: guenther.rezniczek@rub.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Dept. OBGYN Ruhr University Bochum
44625 Herne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Clemens Tempfer, MD
Phone: +49 2323 499
Phone (ext.): 1801
E-Mail: clemens.tempfer@marienhospital-herne.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Cervical cancer is one of the most common cancers in women and one of the leading causes of

death in women worldwide. Pre-cancerous lesions (dysplasias) are detected by the preventive

smear test at the gynecologist and can thus contribute to a 100% chance of cure if they are

clarified by a colposcopic examination as part of the dysplasia consultation and dysplastic

lesions are then surgically removed if necessary (conization).

In practice, there are four different methods by which conization can be performed: Knife

Conization, Laser Conization, Large Loop Excision of the Transformation Zone (LLETZ) and Loop

Electrical Excision Procedure (LEEP). The first three methods have in common that they aim to

remove the entire transformation zone. The rationale for this is that both the precancerous

lesions and the cervical carcinoma itself originate in the transformation zone of the cervix.

This thesis would support the idea of resecting the lesion while taking the remaining healthy

transformation zone along as a precaution. However, it is clear that with the removal of the

entire transformation zone, healthy tissue is removed in addition to the lesion itself. Any

increase in radicality may increase the complication rate of the procedure, especially with

regard to the most feared long-term complication of preterm birth, because the more cervical

tissue is removed, the higher the risk of subsequent preterm birth. This connection speaks in

favor of the use of LEEP, in which only the visible dysplastic tissue in healthy tissue is

removed in the sense of a radical resection, without at the same time also removing the

entire transformation zone, especially in women who still wish to have children.

In summary, the aim of conization is on the one hand to achieve a high level of oncological

safety (low recurrence rate, high R0 resection rate) by resecting sufficient dysplastic

tissue, and on the other hand to avoid excessive tissue resection, because this would

increase the risk of premature birth in a subsequent pregnancy.

There is no direct head-to-head comparison between LEEP and LLETZ in the literature regarding

oncologic safety, for which complete resection of the dysplastic lesion (so-called 'in-sano

resection') is the most appropriate postoperative surrogate parameter. In a Pubmed literature

search (search date: February 10, 2021, search terms: conization, LEEP, LLETZ, resection

margin, randomized), no prospective randomized study on this topic was found. Further

clinical studies are therefore useful to optimize surgical therapy for cervical dysplasia

The primary objective of the present study is to compare LLETZ (resection of the dysplastic

lesion including the transformation zone) with targeted resection of the colposcopically

conspicuous lesion only (LEEP) and to compare it with regard to oncological safety (defined

as non-in-sano rate).

For this purpose, patients with histologically confirmed CIN II/III will be randomly assigned

to one of the two surgical methods. In order to exclude an unwanted influence by

unconsciously different behavior of the patients, the patient will only learn about the

surgical method performed on her after the control examination 6 months postoperatively

(unilateral blinding). The surgeon is not blinded for obvious technical reasons. However, in

case of complications, access to the surgical report and the chosen method is possible at any

time.

Immediately postoperatively, the specimen is examined histologically and evaluated with

regard to the depth of the conus and the degree of dysplasia as well as the resection margins

(R0= free resection margin; R1= dysplasia extends to the resection margin) by a pathology

specialist.

After an interval of 6-8 months, the first follow-up examination (the so-called "test of

cure") with PAP smear and HPV test is performed in accordance with the guidelines. The two

groups are compared with regard to normalization of the Pap smear, HPV status and colposcopic

findings (including histology in the case of colposcopic abnormalities).

For patients with negative HPV test, unremarkable cytology, histology and colposcopy, the

study is terminated. These patients are considered cured and discharged to regular screening

with their established gynecologist. In case of abnormalities, the further procedure is

determined according to the usual clinical criteria in conformity with the guidelines:

clinical control after 3 and/or 6 months or re-conization.

Secondary target criteria of the study are, in addition to the intra- and postoperative

complication rate, the pain perception of the patients and the intraoperative blood loss,

also the rate of negative high risk HPV tests after 6-8 months, since a negative HPV test is

generally regarded as evidence of successful treatment. Thus, the negative predictive value

for a negative HPV test after conization ranges from 92% to 100%. Successful therapy usually

results in elimination of the HP virus. Accordingly, a negative HPV test excludes CIN

persistence or recurrence with a high probability. In contrast, a persistently positive HPV

test may be taken as an indication of persistence of dysplasia or as an indicator of

recurrent dysplasia.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)

- Colposcopically visible lesion

- No therapy of the disease so far

Exclusion Criteria:

- Pregnancy of the patient at/after inclusion in the study; pregnancy after conization

and before the control after 6 months is possible and does not lead to exclusion from

the study.

- Taking immunosuppressive drugs (incl. glucocorticoids)

- Known HIV positivity

- Malignant disease requiring treatment

- Unsatisfactory colposcopy

Studien-Rationale

Primary outcome:

1. Surgical specimen margin status (Time Frame - Pathology assessment of the cone specimen (within 2-4 days after surgery)):
Oncological safety as defined by the rate of specimens with involved margins, i.e. cervical dysplasia present at the edge of the surgical specimen.

Secondary outcome:

1. Intraoperative and postoperative complication rate (Time Frame - During and within 3 weeks after the procedure):
Rate of complications such as excessive bleeding, re-operation, unplanned readmission, infection

2. Cone size (Time Frame - During surgery):
Size of the resected tissue

3. Patient's pain (Time Frame - Immediately after the surgery):
Pain experienced by the patients (11-item Visual Analogue Scale); minimum 0 (no pain), maximum 10 (unbearable pain)

4. HPV clearance (Time Frame - 6 months post surgery):
HPV high-risk positivity by PCR

5. Cone volume (Time Frame - During surgery):
Volume of the resected tissue

Studien-Arme

Other: LLETZ group
LLETZ (large loop excision of the transformation zone) is one of several possible surgical interventions for treating cervical dysplasia.
Other: LEEP group
LEEP (loop electrosurgical excision procedure) is one of several possible surgical interventions for treating cervical dysplasia.

Geprüfte Regime

LLETZ (Large Loop Excision of the Transformation Zone):
LLETZ is one of several possible surgical interventions for treating cervical dysplasia. The transformation zone of the cervix is completely removed
LEEP (Loop Electrosurgical Excision Procedure):
LEEP is one of several possible surgical interventions for treating cervical dysplasia. Only the dysplastic lesion is removed without removing the whole transformation zone.

Quelle: ClinicalTrials.gov

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