Robotic and endoscopic trans-oral total laryngectomy, a systematic review and meta-analysis.

Trans-oral total laryngectomy (TOTL) is a novel minimally invasive approach to narrow-field laryngectomy. The objective of this study was to review published data on robotic and endoscopic-assisted TOTL to examine oncologic, functional, and adverse outcomes. MEDLINE, Web of Science, and Cochrane databases were searched between January 2009 and December 2023. PRISMA guidelines were used for data abstraction independently by two reviewers. Proportional meta-analysis (random effects model) was used for analysis. Main outcomes included oncologic outcomes (margin status, recurrence rate) and surgical complications (fistula, hemorrhage, need for second operation). Eight studies were included (total of 37 patients). Cases included 31 robotic-assisted, 3 endoscopic-assisted, and 3 robotic cases which required conversion to open approach. Most cases were performed for laryngeal SCC (22 patients, 59.5%). Primary closure was achieved in all patients. Negative margins were achieved in 20 of 21 patients with LSCC. Recurrence data was reported in 20 LSCC patients with disease recurrence in 4 patients (20%). Follow-up was described for 15 patients (mean of 3.5 years, range 1.6-5.8 years). Eleven complications occurred including fistula, bleed, and stomal stenosis with a pooled rate of 33.7% (95% CI: 16.4-53.0%, I2 = 0). Six fistulas occurred with a pooled rate of 23.2% (95% CI: 5.8-45.4%, I2 = 0). TOTL is an emerging treatment modality appropriate for select patients requiring TL and offers a minimally invasive approach with less tissue disruption. This is the first systematic review and meta-analysis to examine its oncologic outcomes and complications. Larger case series with adequate follow-up are needed to better characterize TOTL outcomes.

Reliability and outcomes of lymph nodes biopsy in cT1-cT2 N0 supraglottic laryngeal squamous cell carcinoma.

BACKGROUND: In oral and oropharyngeal squamous cell carcinoma (SCC), sentinel node biopsy (SNB) was described as a reliable and reproductive alternative to elective neck dissection for the staging of clinical N0 T1-T2 patients. The SNB technique in supraglottic laryngeal SCC was successfully described in small series. The aim of this study is to analyze retrospectively the results of SNB technique in supraglottic SCC in CHU Godinne, to determine if the technique is reliable and may be proposed in a future multicentral prospective trial. METHODS: The study involved a retrospective analysis of 39 patients who underwent surgery between 2003 and 2019 at CHU Godinne. All patients presented with clinical N0 neck status. The SNB procedure included general anesthesia, 99-technetium colloid peritumoral injection, and lymphoscintigraphy. The hand-held gamma probe was utilized for SNB after tumoral resection during the same operating session. Out of 39 patients, 36 underwent SNB as the sole staging tool, while 3 patients received SNB in combination with elective neck dissection. Primary outcome was the 2-years neck recurrence-free survival (RFS). Secondary outcomes were the 2- and 5-years disease-specific survival (DSS). Additionally, sensitivity and negative predictive value (NPV) of the SNB technique were analyzed. RESULTS: Sentinel nodes were successfully identified in all 39 patients. An average of 4 nodes excised per patient. Positives SN were detected in 23% (9 in 39) cases, leading to subsequent selective neck dissection. Two cases of neck recurrence were observed, both considered as false negatives, occurring after an average of 3.5 months. Th median follow-up period was 48 months with a 2-year RFS of 95%. Sensitivity and NPV of the SNB technique were found to be 82% and 94%, respectively. Two and five years DSS were 84% and 71.7%, respectively. CONCLUSIONS: The results suggest that SNB in T1-T2 supraglottic SCC is a feasible and reliable technique for managing the neck in N0 early-stage patients. However, to establish its oncological equivalence with selective node dissection, further prospective and comparative studies are warranted. The findings of this study underscore the importance of ongoing research in refining and validating the role of SNB in the management of supraglottic SCC, potentially paving the way for more widespread adoption in clinical practice.

Aggressive recurrent respiratory papillomatosis: A series of five consecutive patients successfully treated with adjuvant intravenous bevacizumab. A single Belgian academic center experience.

BACKGROUND: Recurrent respiratory papillomatosis (RRP) is a currently incurable benign neoplasm caused by human papilloma virus (HPV) infection. It usually reduces voice, respiratory, and general quality of life, and is sometimes life-threatening. Patients usually need repeated operations. The use of adjuvant bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor A, has been described in several case reports, with a good efficacy and safety profile. METHODS: We report the cases of five patients with aggressive RRP who were treated with adjuvant systemic bevacizumab in a single Belgian tertiary center. RESULTS: A complete response was achieved in four patients after a median of 4.5 months, and a partial response in one. In all cases, the number of surgeries was drastically reduced, and quality of life improved. Toxicity was easily managed. CONCLUSIONS: Systemic bevacizumab seems to be an effective and safe adjuvant treatment for aggressive RRP.

Single-port transoral robotic surgery hypopharyngectomy.

Transoral robotic surgery (TORS) is an established treatment for many subsites of Head and Neck cancer. With the improved flexibility and access of the single-port (SP) robotic system, tumors within the distal upper aerodigestive tract can now be reached and successfully treated with all the published advantages of transoral endoscopic surgery. Here in we offer the first published surgical technique for SP TORS for resectable hypopharyngeal carcinoma. The video presented demonstrates many important aspects utilizing the enhanced robotic system, including adjustments of the semi-flexible endoscope and use of the third transoral surgical instrumentation. As previously reported, TORS hypopharyngectomy should be considered for resectable tumors to improve upon the deleterious effects of open surgical resection or chemoradiation therapy.

Anatomical-based classification for transoral base of tongue resection.

BACKGROUND: To propose a classification of transoral base of tongue (BOT) procedures able to provide uniform terminology in order to better define postoperative results. METHODS: The classification resulted from the consensus of the different authors and is based on anatomical and surgical principles. RESULTS: The classification comprises three types of BOT resections: type 1 is the resection of the entire lingual tonsil to the muscular plane; type 2 is performed by removing the entire lingual tonsil and part of BOT muscles; type 3 is performed by removing the entire lingual tonsil and the entire BOT muscles. Based on the extension of the dissection, we can use the suffix A (contralateral BOT), B (supraglottic larynx), C (lateral oropharynx), and/or D (oral tongue). CONCLUSION: The proposed classification could allow us to easily compare data from different centers.

Bleeding Complications After Transoral Robotic Surgery: A Meta-Analysis and Systematic Review.

OBJECTIVE: Postoperative hemorrhage is the most common complication of transoral robotic surgery (TORS), the severity of which can range from minor bleeding treated with observation to catastrophic hemorrhage leading to death. To date, little is known about the incidence, risk factors, and management of post-TORS hemorrhage. STUDY DESIGN: Systematic Review and Metanlysis. METHODS: A systematic review of the published literature using the Cochrane Handbook for Systematic Reviews of Interventions was performed and examined TORS, postoperative hemorrhage, and the use of prophylactic transcervical arterial ligation (TAL). RESULTS: A total of 13 articles were included in the analysis. To date, there have been 332 cases of hemorrhage following a total of 5748 TORS. The pooled median post-TORS hemorrhage rate was 6.47%. The overall incidence of minor and major hemorrhage was 5.29% and 2.90%. Patients with prior radiation (relative risk [RR] = 1.46, 95% confidence interval [CI] = 1.00-2.12), large tumors (RR = 2.11, 95% CI = 1.48-2.99), and those requiring perioperative coagulation (RR = 2.25, 95% CI = 1.54-3.28) had significantly higher relative risks of hemorrhage. There was no significant difference in the relative risk of overall hemorrhage with TAL. Looking at major hemorrhage, patients undergoing TAL had a large but insignificant relative risk reduction in post-TORS hemorrhage (RR = 0.40, 95% CI = 0.15-1.07). CONCLUSION: The incidence of post-TORS hemorrhage is low (5.78%), and for major hemorrhage requiring emergent embolization, TAL, or tracheotomy to control hemorrhage it is even lower (2.90%). Large tumors, perioperative anticoagulation, and prior radiation were associated with significantly increased risk of post-TORS hemorrhage. TAL does not reduce the overall incidence of post-TORS hemorrhage but may lead to fewer severe hemorrhages. LEVEL OF EVIDENCE: III Laryngoscope, 131:95-105, 2021.

Transoral robotic surgery hypopharyngectomy (TORSH): feasibility and outcomes.

PURPOSE: With the development of minimal invasive procedure, trans-oral robotic surgery (TORS) is expanding in the field of ENT. Most reviews focus on oropharyngeal and laryngeal (supra-glottic) localization. We report here the feasibility and outcomes of TORS hypopharyngectomy (TORSH) for selected patients with hypopharyngeal tumor. METHODS: Between September 2009 and July 2017, 22 patients, retrospectively included, underwent TORSH with curative intent. RESULTS: From 22 successful hypopharyngectomy, no conversion to open procedure was needed. Three patients (13%) presented a post-operative bleeding and were managed by surgical revision. No fistula was encountered. The 3-year overall survival and disease-specific survival rates were 54 and 92%, respectively. Patients started oral feeding after an average of 7 days. Naso-gastric feeding tubes were removed after a median period of 16 days. Two patients (9%) needed a transient gastrostomy (< 1 year). Three patients (13%) received a transient tracheostomy (< 2 months). Median hospitalization stay was 13 days. CONCLUSIONS: TORSH is a safe technique. Patients' outcomes are favorable and the post-operative morbidity is reduced compared to open neck approach. Hospitalization length and safe swallowing time are reduced.

Individualized Prophylactic Neck Irradiation in Patients with cN0 Head and Neck Cancer Based on Sentinel Lymph Node(s) Identification: Definitive Results of a Prospective Phase 1-2 Study.

PURPOSE: This prospective, nonrandomized, interventional phase 1-2 study investigated the individualization of elective node irradiation in clinically N0 head and neck squamous cell carcinoma by sentinel lymph node (SLN) mapping with single-photon emission computed tomography/computed tomography (SPECT/CT) and its impact on tumor control and radiation-related toxicity. METHODS AND MATERIALS: Forty-four patients with clinically N0 head and neck squamous cell carcinoma treated with definitive (chemo-)radiation therapy were imaged with SPECT/CT after 99mTc nanocolloid injection around the tumor. The neck levels containing up to the 4 hottest SLNs were selected for prophylactic irradiation. A comparative virtual planning was performed with the selection of neck levels based on the current international guidelines. Regional control was monitored as a function of the selected volume. Dosimetric data for the organs at risk were compared between the plans. Normal tissue complication probability (NTCP) rates were derived for xerostomia, dysphagia, and hypothyroidism to predict the clinical benefit and correlated to quality-of-life (QoL) assessments at 6 months. RESULTS: Sixteen percent of patients presented unpredicted lymphatic drainage, and 48% drained unilaterally. The nodal clinical target volume based on lymphoscintigraphy was smaller than the nodal clinical target volume based on international guidelines by a factor of 2 (P < .0001). After a median follow-up of 46 months, only 1 patient experienced a regional relapse in a nonirradiated area. Significant median dose reductions to organs at risk were observed, particularly to contralateral salivary glands in patients with unilateral drainage (14.6-28.1 Gy) and to the thyroid gland in all patients (22.4-48.9 Gy). Median NTCP reductions were observed for xerostomia (0.3% to 13.7%), dysphagia (1.7% to 10.8%), and hypothyroidism (14.0% to 36.1%). QoL at 6 months was improved, particularly in patients irradiated unilaterally. CONCLUSIONS: Neck SLN mapping with SPECT/CT individualizes and reduces the elective nodal target volumes without compromising the regional control. The NTCP rates were reduced and favorable QoL were observed in all patients, particularly in the case of unilateral irradiation.

Anatomical-based classification for transoral lateral oropharyngectomy.

PURPOSE: The aim of the study is proposing a classification of different transoral lateral oropharyngectomy procedures in order to ensure better definitions of post-operative results. METHODS: The classification resulted from the consensus of the different authors and was based on anatomical-surgical principles. RESULTS: The classification comprises three types of lateral oropharyngectomy: type 1 is the resection of the palatine tonsil deep to the pharyngobasilar fascia; type 2 is performed by removing the entire palatine tonsil, the palatoglossus muscle, the palatopharyngeal muscle and the superior constrictor muscle; type 3 is performed by removing the entire palatine tonsil, the palatoglossus muscle, the palatopharyngeal muscle, the superior constrictor muscle, the buccopharyngeal fascia with extension to the pterygoid muscle and parapharyngeal space fat content. Based on the extension of the dissection we can use the suffix A (soft palate), B (posterior pharyngeal wall), C (base of tongue) and D (retromolar trigone). CONCLUSION: The proposed classification introduces a simple and easy to use categorization of transoral lateral oropharyngectomies into three classes. Resection extensions are easily described using suffixes.

Surgical consensus guidelines on sentinel node biopsy (SNB) in patients with oral cancer.

BACKGROUND: The eighth international symposium for sentinel node biopsy (SNB) in head and neck cancer was held in 2018. This consensus conference aimed to deliver current multidisciplinary guidelines. This document focuses on the surgical aspects of SNB for oral cancer. METHOD: Invited expert faculty selected topics requiring guidelines. Topics were reviewed and evidence evaluated where available. Data were presented at the consensus meeting, with live debate from panels comprising expert, nonexpert, and patient representatives followed by voting to assess the level of support for proposed recommendations. Evidence review, debate, and voting results were all considered in constructing these guidelines. RESULTS/CONCLUSION: A range of topics were considered, from patient selection to surgical technique and follow-up schedule. Consensus was not achieved in all areas, highlighting potential issues that would benefit from prospective studies. Nevertheless these guidelines represent an up-to-date pragmatic recommendation based on current evidence and expert opinion.

Evolution of self-perceived swallowing function, tongue strength and swallow-related quality of life during radiotherapy in head and neck cancer patients.

BACKGROUND: Radiation-associated-dysphagia is a serious side effect of radiotherapy (RT) for head and neck cancer (HNC). METHODS: Seventy-six patients had a weekly prospective follow-up from baseline until one week post-RT. Combined mixed model analysis (n = 43) determined the evolution of self-perceived swallowing function, isometric tongue strength (MIP), tongue strength (TS) during swallowing (Pswal), and quality of life (QoL) in these patients during RT. RESULTS: Swallowing deteriorated from the third week on, resulting in an increase of tube dependency from 10% at baseline toward 31% post-RT. Both MIP and Pswal are reduced, with anterior MIP decreasing in 29% of patients and posterior MIP in 17%. Pswal decreases for saliva and a bolus swallow. All QoL subscales except "sleep" were affected during RT. CONCLUSIONS: Self-perceived swallowing function, TS and QoL decrease during RT for HNC. Current findings highlight the need for early monitoring of these parameters.

Transoral Robotic Surgery Total Laryngectomy.

OBJECTIVE: The aim of our study is to demonstrate our technique for performing transoral robotic surgical total laryngectomy (TORS-TL) with the use of the da Vinci robotic system. MATERIALS AND METHODS: We provide a comprehensive description of the TORS-TL operative techniques. Two fresh-frozen human cadavers were selected after ethics approval to describe the appropriate step-by-step surgical resection. We adopted a 5-step procedure that was later applied to 2 of our patients. The first patient presented initially with a squamous cell carcinoma (SCC) in the laryngeal glottis area. A lack of clinical response to initial treatment by chemoradiotherapy led to the decision of performing salvage TL surgery. The second patient had a previous history of head and neck SCC (HNSCC); he had no recurrence of his primary tumor but suffered significantly from postoperative breathing and swallowing difficulties due to severe laryngeal incompetence. RESULTS: TORS-TL was successfully performed in all cases. The operative time for the cadavers was approximately 65 and 55 min, respectively. It was significantly longer for the patients, 210 and 235 min, respectively, despite the fact that exactly the same steps were followed throughout all procedures. There were no intra- or postoperative complications or surgical morbidity related to the use of the da Vinci system. CONCLUSION: TORS-SL for SCC was performed in a safe, reliable, and smooth manner and was shown to be successful in treating our patients. We thus believe that our step-by-step surgical technique for TORS-SL is efficient and reproducible.

Recurrent Masses after Testicular Cancer: Growing Teratoma Syndrome. A Case Report and Review of the Literature.

BACKGROUND: Growing teratoma syndrome is a rare syndrome that affects patients with nonseminomatous germ-cell tumors (NSGCTs). It is characterized by recurrent growing masses that appear during or after chemotherapy in the presence of normal levels of tumor markers. Histological examination is the only way to confirm the diagnosis. CASE PRESENTATION: We present the case of a 36-year-old man who developed recurrent masses after curative treatment for NSGCT of the testicle. His tumor markers were normal. The patient was cured after multiple surgical procedures. CONCLUSIONS: Close follow-up after treatment for NSGCT is very important for early detection of this syndrome, which can occur even many years after tumor onset. Normal blood makers can be misleading, and surgery remains the only curative treatment.

Feasibility of tongue strength measurements during (chemo)radiotherapy in head and neck cancer patients.

PURPOSE: The aim of this study was to investigate the feasibility of tongue strength measures (TSMs) and the influence of bulb location, sex, and self-perceived pain and mucositis in head and neck cancer (HNC) patients during chemoradiotherapy (CRT). METHODS: Twenty-six newly diagnosed HNC patients treated with CRT performed anterior and posterior maximal isometric tongue pressures by means of the Iowa Oral Performance Instrument (IOPI). The Oral Mucositis Weekly Questionnaire (OMWQ) and a Visual Analogue Scale (VAS) for pain during swallowing were completed weekly from baseline to 1 week post CRT. RESULTS: Feasibility of TSMs during CRT declines significantly from 96 to 100% at baseline to 46% after 6 weeks of CRT. But post-hoc analyses reveal only significant differences in feasibility between baseline and measurements after 4 weeks of treatment. No effect of gender or bulb location was established, but feasibility is influenced by pain and mucositis. CONCLUSIONS: Feasibility of TSMs declines during CRT and is influenced by mucositis and pain. For the majority of subjects, TSMs were feasible within the first 4 weeks, which provides a window of scientific and clinical opportunities in this patient population.

Unilateral vocal fold immobility: a tertiary hospital's experience over 5 years.

The objective of the study was to determine the etiology and subsequent management of patients with unilateral vocal fold immobility (UVFI) and compare our results with other such studies. This was a retrospective case series of all patients that were treated for UVFI at one single tertiary referral centre between 2010 and 2014. The medical records of 161 patients over a 5-year period diagnosed with UVFI were analyzed. We looked at the patient demographics, side of immobility, etiology, management and voice assessment. A total of 21 patients were excluded due to varying reasons including second presentation and incomplete data. Our results demonstrated 37.1% of cases to be due to non-thyroid surgery (mainly vascular or anterior cervical spine surgery) compared to thyroid or parathyroid (18.6%). Carotid endarterectomy was the commonest cause followed by cervical spine discectomy or fusion. Other iatrogenic causes included thoracic surgery either involving the lung or not. Our results are very much in keeping with those seen by our colleagues in North America. A better appreciation of the causes of UVFI especially in cases not performed by otolaryngologists and head and neck surgeons should be highlighted and the necessary steps should be taken to prevent this iatrogenic complication.

A european multicenter study evaluating the flex robotic system in transoral robotic surgery.

OBJECTIVES/HYPOTHESIS: To evaluate the application of the Flex Robotic System in transoral robotic surgery (TORS). STUDY DESIGN: Multicenter, prospective, open-label, single-armed clinical study. METHODS: A prospective clinical follow-up multicenter study was performed from July 2014 to October 2015 assessing the safety and efficacy of the Medrobotics Flex Robotic System for access and visualization of the oropharynx, hypopharynx, and larynx as well as for resection of benign and malignant lesions. A total of 80 patients were enrolled. Access and visualization of five anatomic subsites (base of tongue, palatine tonsil area, epiglottis, posterior pharyngeal wall, and false vocal cords) were individually graded by the surgeon. Setup times, access and visualization times, surgical results, and adverse events were documented. RESULTS: The relevant anatomic structures could be exposed and visualized properly in 75 patients, who went on to have a surgical procedure performed with the Flex Robotic System. Access and visualization of the palatine tonsil area, posterior pharyngeal wall, epiglottis, and posterior pharyngeal wall were excellent. However, false vocal cords and vocal cords were more difficult to expose. Seventy-two patients were treated successfully with the Flex Robotic System. There were no serious or unanticipated device-related adverse events caused by the Flex Robotic System. CONCLUSIONS: Lesions in the oropharynx, hypopharynx, and larynx could be successfully resected with the Flex Robotic System, specifically developed for TORS. Our study provides evidence that the Flex Robotic System is a safe and effective tool in TORS. Laryngoscope, 2016 127:391-395, 2017.

Comprehensive cost analysis of sentinel node biopsy in solid head and neck tumors using a time-driven activity-based costing approach.

Head and neck cancer (HNC) is predominantly a locoregional disease. Sentinel lymph node (SLN) biopsy offers a minimally invasive means of accurately staging the neck. Value in healthcare is determined by both outcomes and the costs associated with achieving them. Time-driven activity-based costing (TDABC) may offer more precise estimates of the true cost. Process maps were developed for nuclear medicine, operating room and pathology care phases. TDABC estimates the costs by combining information about the process with the unit cost of each resource used. Resource utilization is based on observation of care and staff interviews. Unit costs are calculated as a capacity cost rate, measured as a Euros/min (2014), for each resource consumed. Multiplying together the unit costs and resource quantities and summing across all resources used will produce the average cost for each phase of care. Three time equations with six different scenarios were modeled based on the type of camera, the number of SLN and the type of staining used. Total times for different SLN scenarios vary between 284 and 307 min, respectively, with a total cost between 2794 and 3541€. The unit costs vary between 788€/h for the intraoperative evaluation with a gamma-probe and 889€/h for a preoperative imaging with a SPECT/CT. The unit costs for the lymphadenectomy and the pathological examination are, respectively, 560 and 713€/h. A 10 % increase of time per individual activity generates only 1 % change in the total cost. TDABC evaluates the cost of SLN in HNC. The total costs across all phases which varied between 2761 and 3744€ per standard case.

Sentinel Node in Oral Cancer: The Nuclear Medicine Aspects. A Survey from the Sentinel European Node Trial.

PURPOSE: Nuclear imaging plays a crucial role in lymphatic mapping of oral cancer. This evaluation represents a subanalysis of the original multicenter SENT trial data set, involving 434 patients with T1-T2, N0, and M0 oral squamous cell carcinoma. The impact of acquisition techniques, tracer injection timing relative to surgery, and causes of false-negative rate were assessed. METHODS: Three to 24 hours before surgery, all patients received a dose of Tc-nanocolloid (10-175 MBq), followed by lymphoscintigraphy. According to institutional protocols, all patients underwent preoperative dynamic/static scan and/or SPECT/CT. RESULTS: Lymphoscintigraphy identified 723 lymphatic basins. 1398 sentinel lymph nodes (SNs) were biopsied (3.2 SN per patient; range, 1-10). Dynamic scan allowed the differentiation of sentinel nodes from second tier lymph nodes. SPECT/CT allowed more accurate anatomical localization and estimated SN depth more efficiently. After pathological examination, 9.9% of the SN excised (138 of 1398 SNs) showed metastases. The first neck level (NL) containing SN+ was NL I in 28.6%, NL IIa in 44.8%, NL IIb in 2.8%, NL III in 17.1%, and NL IV in 6.7% of positive patients. Approximately 96% of positive SNs were localized in the first and second lymphatic basin visualized using lymphoscintigraphy. After neck dissection, the SN+ was the only lymph node containing metastasis in approximately 80% of patients. CONCLUSIONS: Best results were observed using a dynamic scan in combination with SPECT/CT. A shorter interval between tracer injection, imaging, and surgery resulted in a lower false-negative rate. At least 2 NLs have to be harvested, as this may increase the detection of lymphatic metastases.

Sentinel European Node Trial (SENT): 3-year results of sentinel node biopsy in oral cancer.

PURPOSE: Optimum management of the N0 neck is unresolved in oral cancer. Sentinel node biopsy (SNB) can reliably detect microscopic lymph node metastasis. The object of this study was to establish whether the technique was both reliable in staging the N0 neck and a safe oncological procedure in patients with early-stage oral squamous cell carcinoma. METHODS: An European Organisation for Research and Treatment of Cancer-approved prospective, observational study commenced in 2005. Fourteen European centres recruited 415 patients with radiologically staged T1-T2N0 squamous cell carcinoma. SNB was undertaken with an average of 3.2 nodes removed per patient. Patients were excluded if the sentinel node (SN) could not be identified. A positive SN led to a neck dissection within 3 weeks. Analysis was performed at 3-year follow-up. RESULTS: An SN was found in 99.5% of cases. Positive SNs were found in 23% (94 in 415). A false-negative result occurred in 14% (15 in 109) of patients, of whom eight were subsequently rescued by salvage therapy. Recurrence after a positive SNB and subsequent neck dissection occurred in 22 patients, of which 16 (73%) were in the neck and just six patients were rescued. Only minor complications (3%) were reported following SNB. Disease-specific survival was 94%. The sensitivity of SNB was 86% and the negative predictive value 95%. CONCLUSION: These data show that SNB is a reliable and safe oncological technique for staging the clinically N0 neck in patients with T1 and T2 oral cancer. EORTC Protocol 24021: Sentinel Node Biopsy in the Management of Oral and Oropharyngeal Squamous Cell Carcinoma.