SURGICAL TREATMENT OF ORAL LEUKOPLAKIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL COMPARING SURGERY WITH WAIT AND SEE APPROACH

Rationale of the study: Different treatments have been proposed for the management of the most common oral potentially malignant disorders (i.e., leukoplakia and erythroleukoplakia) in order to prevent the risk of oral cancer. However, there is currently no consensus on the most effective approach for the patients affected by such lesions. Surgery is often performed, but in literature there is no randomized clinical trial that demonstrates its real effectiveness in preventing malignant transformation. Objective: To compare the incidence of oral squamous cell carcinoma (OSCC) in a group of subjects undergoing surgical treatment and a similar group under strict clinical and histological surveillance (“wait and see” approach). To evaluate the long-term recurrence rate in test group after surgical excision of the oral leukoplakia. Study Design: Multicentric randomized controlled clinical trial (RCT). Setting: Unit of Oral Medicine - ASST Santi Paolo e Carlo Milano - Head and Neck Department San Paolo Hospital of Milan - Università degli Studi di Milano - Reference Center of the study; Unit of Oral and Medicine and Oncology - CIR Dental School of Turin - Università degli Studi di Torino Patients and Method: Inclusion criteria: adult patients to whom, after an incisional diagnostic biopsy, have been diagnosed an oral leukoplakia or erythroplakia. Exclusion criteria: patients affected by a previous oral cancer, patients under the age of 18, pregnant patients, patients affected by PVL, lesions located in anatomical risk areas in which the excision may cause post-surgical deficit (salivary ducts, nerves, arteries…) and lesions more extensive than 3cm. Patients included in the study are divided into two groups: surgery (test group) and wait and see (control group). The randomization has been created using an online tool. Demographics data, habits, clinical information are collected for both groups. Technique of excision, surgical margins, recurrence and intra and post-surgical complications, are collected in the test group, while clinical and histopathological changes are collected in the control group. Outcomes Primary: oral cancer incidence Secondary: time to malignant progression from diagnosis, recurrence rate in test group. Conclusion and clinical relevance: This study will compare surgical treatment with “wait and see” approach in order to evaluate the real effectiveness of surgery in preventing and reducing oral cancer incidence in a group of subjects affected by oral leukoplakia. This study will contribute to determine which is the most appropriate management for such patients and to establish a gold-standard treatment.