Clinical trial NCT04911075: Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application
Official title: Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervix; Intraepithelial Neoplasia
Keywords: Trichloroacetic Acid (TCA)
Depth of Necrosis
Cervix Intraepithelial Neoplasia
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dr Cipto Mangunkusumo General Hospital
First posted: 2021-06-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Early detection and treatment of precancerous lesions are the pillars of cervical cancer prevention. Cervical Intraepithelial Neoplasia (CIN) is a precancerous lesion that histologically can be found in one of three stages of development; CIN-I (low grade), CIN-II, or CIN-III (collectively called high grade), depending on the proportion of the depth of the lesion to the thickness of the cervical epithelium. The higher the degree of CIN, the deeper the pre-cancerous lesions are found in the epithelial lining of the cervix. Therefore, from the point of view of precancerous lesions treatment, its effectiveness will be determined by the ability to eradicate all high-grade lesions. In other words, it has an effect that can reach depths beyond the depth of the high grade lesion.

According to a study in the US (1982), as many as 99.7% of CIN-III cases had a lesion depth of less than 4.8 millimeter. Furthermore, a Netherlands study (1990) stated that as many as 99.7% of CIN-III cases had a maximum lesion depth of 3.6 millimeters. While in subjects from developing countries, study from Peru (2018) showed that 93.5% of CIN-III cases have a lesion depth of less than 5 millimeters. Based on the results of these studies, a treatment for CIN can only be said to be effective if it can create a therapeutic effect which can reach depths of 4-5 millimeters in cervix epithelial.

Trichloroacetic acid (TCA) is an acetic acid analogue, which has long been known as a chemical peel and also frequently used to treat genital ward and precancerous skin lesions. The effect of TCA therapy is the destruction of the epithelium forming epithelial necrosis, followed by re-epithelialization of the supporting tissue and stimulation of collagen synthesis within approximately in 24 hours. There are no studies regarding the depth of cervical necrosis that can be achieved by application of this solution to the cervix epithelial.

Detailed description: Primary Objectives:

The purpose of this study is to determine the depth of epithelial necrosis in cervical tissue specimen after 85 percent TCA application on clinically normal cervix.

Procedure:

Patients will receive a single administration of 1-2 milliliter of 85 percent TCA in 24 hours before elective total hysterectomy surgery on indication other than cervical pathology. The 85 percent TCA will be applied topically onto the ectocervix and the endocervix canal with a cotton swab for 1-2 minutes. After surgery, cervical specimen will be fixated in formalin and sent for histopathologic examination.

Eligibility criteria: Inclusion Criteria:

* Normal cervix without significant changes and must be tested negative for Visual Inspection Acetic-Acid (VIA) test (no acetowhite lesions are found)
* Participants are willing to participate voluntarily in this research by signing a consent form.

Exclusion Criteria:

* Patients who finally have undergone sub-total or supra-vaginal hysterectomy.
* Any abnormalities found in postoperative cervical histopathology results.

Primary outcomes:
measure: Depth of Cervical Epithelial Ablation
timeFrame: 30 days
Secondary outcomes:
measure: Pain Scores
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: dr. Cipto Mangunkusumo National Central General Hospital
Study officials:
affiliation: Indonesia University
name: Laila Nuranna, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Geisler S, Speiser S, Speiser L, Heinze G, Rosenthal A, Speiser P. Short-Term Efficacy of Trichloroacetic Acid in the Treatment of Cervical Intraepithelial Neoplasia. Obstet Gynecol. 2016 Feb;127(2):353-9. doi: 10.1097/AOG.0000000000001244.
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