Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

Introduction: In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis is suspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCC remains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC. Methods and analysis: This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoint are 3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias. Ethics and dissemination: This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the corresponding author on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals

Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

Introduction In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis issuspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCCremains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC.Methods and analysis This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoints are3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias.Ethics and dissemination This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the correspondingauthor on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals

Convenient Decision Criteria for Surgery in Elderly Patients with Oral Squamous Cell Carcinoma

Elderly patients with oral squamous cell carcinoma (OSCC) have difficulty undergoing curative surgical treatment due to various factors besides age. The purpose of the present study was to study the factors determining surgery in elderly patients with OSCC. We designed and implemented a retrospective cohort study. The study sample included elderly patients aged ≥ 70 years with OSCC and they were statistically compared between the surgery and non-surgery groups. The primary outcome variable was selecting surgery as the treatment plan, while the secondary outcome was the prognosis of each group. The sample comprised 76 patients aged ≥ 70 years with OSCC, of whom 52 treated with surgery and 24 patients treated with non-surgery. As decision factors, performance status (PS), clinical stage, serum Alb level, body mass index (BMI), and Geriatric Nutritional Risk Index (GNRI) were significantly associated with the selection of surgery. Logistic multivariate analysis identified three independent predictive factors for selecting surgery: Alb (≥3.5 vs. <3.5), PS (0, 1, 2, 3), and clinical stage. According to the decision tree analysis, curative surgery is the recommended treatment strategy for elderly patients with Alb ≥ 3.5 g/dL, PS 0, and stage I, II. In conclusion, Alb, PS, and clinical stage may be the criteria for selecting surgery in elderly patients

Comparison of Postoperative Bleeding between Application of Polyglycolic Acid Sheet and Primary Closure in Tongue Cancer Patients with Partial Glossectomy

The technique of covering a mucosal defect with fibrin glue and a polyglycolic acid sheet (MCFP) for the resection of mucosa is applied in oral cancers. The MCFP technique for partial glossectomy provides faster relief from postoperative pain and the prevention of scar contracture, unlike primary closure. However, it has a major complication of postoperative bleeding. This study sought to compare postoperative bleeding between the MCFP technique and primary closure. We designed a retrospective study with a cohort of 57 patients who underwent partial glossectomy with the MCFP technique or primary closure. Our primary predictor variable was the wound closure procedure (primary closure or the MCFP technique). The primary outcome variable was postoperative bleeding, and the other variables were patient characteristics, excision area and depth, tooth contact for the wound, and antithrombotic therapy. Statistical evaluation was performed with Pearson&rsquo;s chi-squared test, Welch&rsquo;s t-test, and multiple logistic regression. P &lt; 0.05 was considered statistically significant. The MCFP technique was selected for cases with a large excision area (1433 vs. 963 mm2, P = 0.029). Total postoperative bleeding occurred in 10 of 57 patients (MCFP technique: 7 of 37 cases; primary closure: 3 of 20 cases). There was no significant difference in bleeding between the two groups (P = 0.71). Postoperative bleeding was significant in patients with antithrombotic therapy (MCFP: 40% vs. primary closure: 2%, P = 0.0024). Postoperative bleeding timing was significantly different in the MCFP technique (6.4 days) from that of primary closure (1 day; P = 0.0076). Postoperative bleeding was not associated with the MCFP technique or primary closure. However, postoperative bleeding with the MCFP technique occurred later than that with primary closure. The MCFP technique is not recommended for patients on antithrombotic therapy

Predictors of Occult Metastasis and Prognostic Factors in Patients with cN0 Oral Cancer Who Underwent Elective Neck Dissection

Elective neck dissection (END) is recommended for the management of patients with oral squamous cell carcinoma (OSCC) because of the risk of occult metastasis (OM). We hypothesized that some factors predict poor prognosis regardless of a cN0 END. This study aimed to investigate the predictors of OM and prognostic factors in patients with cN0 OSCC who underwent supraomohyoid neck dissection (SOHND). A retrospective cohort study design was created and implemented. The primary predictive variables in this study were OM and risk factors for poor prognosis after SOHND. A Cox proportional hazard model was used to adjust for the effects of potential confounders on the risk factors for poor prognoses. Among 86 patients with OSCC, OMs were observed in 9 (10.5%). The neutrophil-to-lymphocyte ratio (NLR) and vascular invasion are good markers for detecting OM. A Cox multivariable analysis identified two independent predictors of overall survival: pathologic node (pN) and laterality of END. An independent predictive factor for disease-free survival, the surgical margin, was also identified in this study. According to the pN classification, pN1 patients had a worse survival rate than pN2 patients. Therefore, in the case of pN1, regardless of being cN0, additional adjuvant therapy may be necessary

Therapeutic Effect of Polidocanol Sclerotherapy on Oral Vascular Malformations

Various treatments for oral vascular malformation (VM) have been reported. Polidocanol and absolute ethanol have also been reported for sclerotherapy. However, there are still few reports on the therapeutic effect and dosage of polidocanol sclerotherapy. Therefore, we examined its therapeutic effects on oral VM. There were 17 sites of VMs, with nine patients diagnosed with oral VM at the Department of Dental and Oral Surgery, Tsukuba University Hospital. The medical records were retrospectively investigated to determine the site, hemangioma volume, polidocanol injection volume, and therapeutic effect. The volume of hemangiomas was calculated using magnetic resonance images. Based on the site, oral VMs were observed in the tongue, buccal mucosa, lips, and oral floor in eight, three, five, and one patients, respectively. The average size of the site was 3071 mm3. The average injection dose of polidocanol at one site was 2.86 mL, the average number of administrations was 1.6, and the response rate was 88.2%. No adverse events were observed. The median numerical rating scale scores were 2/10 (0–6/10) and 0/10 (0–1/10) the day after surgery and 1 week after surgery, respectively. Univariate regression analysis of the total dose in successful cases provided the following formula: 1.3 + 0.00025 × volume (mm3) (mg). Polidocanol sclerotherapy is an effective treatment method for oral VM

Medication-Related Osteonecrosis of the Jaw Spontaneously Occurred in a Patient with Chronic Myelogenous Leukemia Only by Imatinib: A Report of a Rare Case

The prevalence of medication-related osteonecrosis of the jaw (MRONJ) associated with molecular-targeted therapies such as bevacizumab and sunitinib has been constantly increasing in recent years. MRONJ frequently occurs after invasive dental procedures such as tooth extraction in patients currently or with a previous history of receiving antiresorptive agents including bisphosphonates and/or denosumab. Here, we report a rare case of spontaneously occurring MRONJ of the mandible in a 52-year-old Japanese woman with chronic myelogenous leukemia (CML) who was administered imatinib for 9 years. She had never been treated with antiresorptive agents, and her MRONJ developed spontaneously. Although there have been few reports of MRONJ related to imatinib, our case reported here indicates that imatinib may be capable of causing spontaneous MRONJ

A Case of Primary Intraosseous Adenoid Cystic Carcinoma of the Mandible

Primary intraosseous adenoid cystic carcinoma (PIACC) of the jaw is rare. To our knowledge, only 51 cases have been reported in the English literature. We present a rare case of PIACC arising in the mandible with multiple bone metastases and review the previous articles. A 70-year-old woman presented with paresthesia of the right chin and lower gingiva for 4 months. Radiography revealed an irregular radiolucent region on the right side of the ramus, infiltrating to the mandibular canal. Biopsy revealed a pathological diagnosis of adenoid cystic carcinoma. Multiple bone metastases were present in the sternum, scapula, and thighs. The treatment effect was progressive disease for chemotherapy; therefore, best supportive care was provided for 3 years

p62 Is a Potential Biomarker for Risk of Malignant Transformation of Oral Potentially Malignant Disorders (OPMDs)

To determine the intracellular behavior of p62, a marker of selective autophagy, in oral potentially malignant disorders (OPMDs). This retrospective study includes 70 patients who underwent biopsy or surgical resection and were definitively diagnosed with OPMDs. Immunohistochemical staining for p62, XPO1, p53, and ki67 was performed on all samples and positive cell occupancy was calculated. We statistically investigated the correlation between protein expression in OPMDs and the association between malignant transformation, clinicopathological characteristics, and occupancy. ki67 expression was negatively correlated with p62 expression in the nucleus (p p p = 0.03) was significantly lower in malignant transformation cases, whereas the expression of p62 in the cytoplasm (p = 0.03) and the aggregation expression (p < 0.01) were significantly higher. Our results suggest that the function of p62 is altered by its subcellular localization. In addition, defects in selective autophagy occur in cases of malignant transformation, suggesting that p62 is a potential biomarker of the risk of malignant transformation of OPMDs