Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application
Condition: Cervix; Intraepithelial Neoplasia
MeSH terms: Neoplasms; Necrosis
Study type: Interventional

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.
    

Intervention name(s): 85% TCA Solution
Intervention type(s): Drug
Intervention description(s): TCA is an acetic acid analogue solution (CCl3COOH) which is formed from the reaction of acetic acid (CH3COOH) with chlorine (3Cl2).
High concentrations (85 percent) of this solution can penetrate deeply into the epidermis-dermis layer and cause cells necrosis.
This solution (1-2 milliliter) will be applied to participants cervical tissue (ectocervix and endocervix) using cotton swab for 1-3 minutes.
Other intervention name(s): CCl₃COOH
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trichloroacetic Acid (TCA); Depth of Necrosis; Cervix Intraepithelial Neoplasia