The quality of life outcome in patients with head and neck squamous cell cancer treated using chemoradiotherapy.

OBJECTIVE: Organ preservation is a goal of head and neck squamous cell cancer (HNSCC) treatment. chemoradiotherapy remains one of the main treatment options and is widely recognized as a method with organ-preserving potential and outcomes comparable to those of surgery. However, few studies have investigated the quality of life (QOL) of patients with HNSCC treated using chemoradiotherapy, therefore, we aimed to retrospectively evaluate how QOL changes pre and post-chemoradiotherapy. METHODS: We evaluated QOL outcomes in patients who underwent initial radical chemoradiotherapy for HNSCC at the Department of Otolaryngology and Head and Neck Surgery Kitasato University Hospital from 2018 to 2021. We used the Cancer Fatigue Scale (CFS) and the combined European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-H&N35 questionnaires at pre-treatment, three months and six months post-treatment. RESULTS: We obtained 37 and 29 responses from the CFS and EORTC QLQ-C30/H&N35 questionnaire, respectively. From the CFS, the physical fatigue score at three months post-treatment deteriorated more than that at pre-treatment, and significantly improved by six months post-treatment. The total score worsened significantly at three months and there was a trend toward improvement at six months. In the EORTC QLQ-C30, physical and social functioning declined in three months and did not improve within six months. Fatigue was substantially worse at three months and significantly improved at six months but did not reach the same level as that before treatment. Appetite loss was also significantly worse at three months. In the QLQ-H&N35 questionnaire, sensory issues, trouble with social contact, and dry mouth were significantly worse at three months and did not improve within six months. Sticky saliva also worsened at three months and significantly improved at six months. CONCLUSION: There were some problems associated with chemoradiotherapy. Some patients showed an improvement, while others continued to have challenges. In Japan, chemoradiotherapy was shown to have a long-term impact on the patient's life.

Effect of Fascia Implantation and Controlled Release of Basic Fibroblast Growth Factor for Muscle Atrophy in Rat Laryngeal Paralysis.

OBJECTIVE: To improve lateral thyroarytenoid (TA) muscle atrophy after laryngeal paralysis, reconstruction of the vascular network of the atrophied muscle is necessary. We therefore evaluated whether the controlled release of basic fibroblast growth factor (bFGF) with autologous fascia implantation could affect vascular reconstruction in the lateral TA muscle. STUDY DESIGN: Animal experiment. SETTING: Laboratory. METHODS: Unilateral laryngeal paralysis was induced in 20 rats. The rats were implanted with autologous fascia and a gelatin hydrogel sheet with or without 1 µg of bFGF (fascia and bFGF + fascia groups; n = 5 each) and with only a gelatin hydrogel sheet with bFGF (bFGF group: n = 5). Another group remained untreated (n = 5) at 4 months after paralysis. At 3 months since transplantation, intra- and intergroup comparisons of the muscle volumes and total area of blood vessels in the lateral TA muscle were performed. RESULTS: When compared with the untreated group, the bFGF + fascia group showed a significant increase in muscle volume (P =.0008) and vascular area (P =.0002) in the lateral TA muscle, whereas the other 2 treated groups demonstrated an insufficient effect. CONCLUSION: bFGF + fascia implantation showed histologic improvement in severe laryngeal paralysis. We demonstrated that the decrease in lateral TA muscle mass after paralysis might be countered by the reconstruction of the vascular network. Our findings indicate that hypovascular and denervated areas of the laryngeal muscle can be regenerated by the implantation of growth factors and scaffolds with surgical stress. LEVEL OF EVIDENCE: 5.

Transoral endoscopic surgical approach to venous malformation of the parapharyngeal space.

We encountered a rare case of venous malformation located in the parapharyngeal space. The 65-year-old female patient did not have any symptoms, and the malformation was discovered incidentally during a clinical survey. Examination of the oral cavity revealed a mass in the left soft palate. Magnetic resonance imaging showed a well-defined mass in the left parapharyngeal space. Fine needle aspiration cytology suggested no malignancy. Four years after the first visit, she underwent surgery for diagnosis and treatment. We safely removed the mass with a rigid videoendoscope trans-orally. No postoperative complications arose, and she was discharged 7 days after the operation. Histopathological examination identified cavernous hemangioma. Venous malformation (cavernous hemangioma) of the parapharyngeal space is very rare, and few cases of removal under a transoral approach using a rigid endoscope with a flexible tip have been reported. This approach is safe and can be recommended for selected tumors of the parapharyngeal space.

A retrospective study of treatment for curative synchronous double primary cancers of the head and neck and the esophagus.

OBJECTIVE: Curative synchronous double primary cancers of the head and neck and the esophagus (CSC-HE) are frequently detected, but a standard treatment remains to be established. We studied the clinical course to explore appropriate treatment strategies. METHODS: We retrospectively studied consecutive 33 patients who had CSC-HE. The disease stage was classified into 4 groups: group A, early head and neck cancer (HNC) and early esophageal cancer (EC); group B, early HNC and advanced EC; group C, advanced HNC and early EC; and group D, advanced HNC and advanced EC. As induction chemotherapy, the patients received 3 courses of TPF therapy (docetaxel 75mg/m2 on day 1, cisplatin 75mg/m2 on day 1, and 5-fluorouracil 750mg/m2 on days 1-5) at 3-week intervals. The clinical courses and treatment outcomes were studied according to the disease stage of CSC-HE. RESULTS: The disease stage of CSC-HE was group A in 1 patient (3%), group B in 9 patients (27.3%), group C in 3 patients (9.1%), and group D in 20 patients (60.6%). The median follow-up was 26months, and the 2-year overall survival rate was 67.4%. In groups A, B, and C, the 2-year overall survival rate was 83.3%. In group D, the 2-year overall survival rate was 62.6%. Ten of 20 patients in group D received induction chemotherapy with TPF, and 6 patients were alive and disease free at the time of this writing. CONCLUSION: The treatment outcomes of patients with CSC-HE were relatively good. TPF induction chemotherapy might be an effective treatment for patients with advanced HNC and advanced EC.

Evaluation of Autologous Fascia Implantation With Controlled Release of Fibroblast Growth Factor for Recurrent Laryngeal Nerve Paralysis Due to Long-term Denervation.

OBJECTIVES: Paralyzed tissue due to long-term denervation is resistant to many treatments because it induces irreversible histological changes and disorders of deglutition or phonation. We sought to determine the effect of autologous transplantation of fascia into the vocal fold (ATFV) with controlled release of basic fibroblast growth factor (bFGF) on long-term unilateral vocal fold paralysis (UVFP). METHODS: Unilateral recurrent laryngeal nerve (RLN) section was performed on 20 rats. Five rats were implanted with autologous fascia only (fascia group), and 10 rats were implanted with autologous fascia and a gelatin hydrogel sheet with 1 µg (1 µg bFGF + fascia group) or 0.1 µg (0.1 µg bFGF + fascia group) of bFGF 4 months after RLN section. We evaluated the normalized glottal gap and laryngeal volume and histological changes 3 months after implantation. RESULTS: The normalized glottal gap was significantly reduced in the 3 fascia implantation groups. Normalized laryngeal volume, fat volume, and lateral thyroarytenoid muscle volume were significantly increased in the 2 fascia implantation with bFGF groups. CONCLUSIONS: The ATFV with controlled release of bFGF repaired the glottal gap and laryngeal volume after RLN section and may reduce the occurrence of aspiration and hoarseness. We speculate that this treatment improves laryngeal function in long-term RLN denervation.

One hundred supracricoid laryngectomies with cricohyoidoepiglottopexy: do we achieve better local control?

OBJECTIVE: Supracricoid laryngectomy with cricohyoidoepiglottopexy has been known to be able to cope with tumor excisions with minimal margins. Extended resection may result in a limited margin and may impair the prognosis. We conducted a clinicopathologic analysis of local recurrence in supracricoid laryngectomy with cricohyoidoepiglottopexy patients. METHODS: Between 1997 and 2013, 100 patients with glottic cancers underwent supracricoid laryngectomy with cricohyoidoepiglottopexy. The clinicopathologic findings were evaluated. We also analyzed: (i) cancer-specific and overall survival rates, (ii) the correlation between locoregional recurrence and overall survival, (iii) T staging and larynx preservation rates and (iv) previous radiation history and larynx preservation rates. RESULTS: Local recurrence was recognized in eight of the 100 patients (8%); all were initially staged as T3 or T4. Recurrence was identified in the submucosal regions of the ipsilateral arytenoid and/or infraglottis. Six patients were salvaged by completion total laryngectomy except two. Cancer-specific survival at 5 years was 93%; overall survival at 5 years was 89%. There was no significant difference between overall survival and locoregional recurrence. There was a significant difference between larynx preservation in T1-2 and T3-4 patients. There was no significant difference between larynx preservation and the previous radiation therapy status. CONCLUSIONS: Our experience convinced us of the clinical potential of supracricoid laryngectomy with cricohyoidoepiglottopexy as one of the effective options for functional larynx preservation. Supracricoid laryngectomy with cricohyoidoepiglottopexy is the most suitable for unfavorable T2 and T3a cases and is applicable for appropriately selected radiation-failed patients. Thorough pre-operative evaluation, proper surgical techniques and careful follow-up are prerequisites for the success of supracricoid laryngectomy with cricohyoidoepiglottopexy.

Treatment of aging vocal folds: surgical approaches.

PURPOSE OF REVIEW: Aging may affect the voice through either physiological or pathological changes. Globally society is aging and the working lifetime is extending. Increasing numbers of elderly will present with voice issues. This review examines current thinking regarding surgical treatment of the aging voice. RECENT FINDINGS: The mainstay of surgical treatment remains injection laryngoplasty and medialization thyroplasty. In-office injection laryngoplasty is increasingly common. Data suggest that patients with vocal fold atrophy do not achieve as much benefit from augmentation treatments as other causes of glottal incompetence. In addition the timing of injection laryngoplasty may influence the rate of subsequent medialization thyroplasty. Disease-specific treatments can provide some benefit to voice, such as deep brain stimulation in Parkinson's disease. Novel treatments including growth factor therapy are entering clinical practice and will provide new options for the clinician in future. SUMMARY: Voice disorders affect approximately 20% of the elderly population. Causes include neurologic, malignant, iatrogenic and benign vocal fold disorders. These should be ruled out before accepting dysphonia is age-related in nature. Treatment should be specific to recognized vocal disorders but may also address physiologic changes in the glottis. Injection laryngoplasty and thyroplasty remain effective options for treating glottal incompetence but novel therapies are showing promising results.

Clinical outcomes of 849 laryngeal cancers treated in the past 40 years: are we succeeding?

OBJECTIVE: We analyzed the clinical outcomes of 849 laryngeal cancers treated in the past 40 years, which overlapped with the era of the global treatment shift. METHODS: To compare the chronological outcomes, patients were divided into four groups according to their registration year as 1972-82, 1983-92, 1993-2002 and 2003-12; treatment trends, larynx preservation rate and overall survival rate were compared. RESULTS: There were 104, 173, 253 and 319 patients registered in 1972-82, 1983-92, 1993-2002 and 2003-12, respectively. Five-year overall survival rates were 74, 76.5, 75.6 and 82.2% in 1972-82, 1983-92, 1993-2002 and 2003-12, respectively. The five-year larynx preservation rates were 65.5, 75.7, 75.4 and 80.9% in 1972-82, 1983-92, 1993-2002 and 2003-12, respectively. CONCLUSIONS: The number of patients treated at our institute increased, and the overall survival and larynx preservation rates exhibited favorable improvements over the past four decades. In the analysis of nonsurgical options, S1 combined radiotherapy showed superiority over concurrent chemoradiotherapy and radiotherapy in larynx preservation, and S1 combined radiotherapy, concurrent chemoradiotherapy and Tegafur Uracil combined radiotherapy showed superiority over radiotherapy in overall survival. In nonsurgical approaches, proper case selection is the key to success and may be much more important than pursuing radiotherapy dose escalation. In the analysis of surgical options, laser and supracricoid laryngectomy with cricohyoidoepiglottopexy contributed to larynx preservation in early- and intermediate-stage cancers, respectively. Supracricoid laryngectomy with cricohyoidoepiglottopexy demonstrated overall survival not worse than total laryngectomy, which is the prerequisite treatment basis for larynx preservation options. We must make extra efforts in pursuing an ideal balance between nonsurgical and surgical larynx preservation options.

A clinical study of transoral pharyngectomies to treat superficial hypopharyngeal cancers.

BACKGROUND: For years, it has been a major interest for surgeons and oncologists to develop a novel technique to detect hypopharyngeal cancers at an early stage and to treat the lesions in a less invasive manner. The advent of the narrow band imaging system combined endoscopy and various endoscopic approaches shed light on the new era of the minimum invasive management of superficial cancers in hypopharyngeal regions. METHODS: Three endoscopic approaches, endoscopic mucosal resection, endoscopic submucosal dissection and endoscopic laryngopharyngeal surgery, were chronologically introduced at our institute. In this study, we focused on the clinical outcomes, advantages and limitations of each procedure. RESULTS: A total of 30 patients (42 procedures) received transoral pharyngectomies between June 2006 and May 2012. Tracheotomy was performed in 9 of 42 (21%) patients. Three patients developed local recurrence and were subsequently controlled by additional transoral pharyngectomies. The 2- and 5-year local control rates were 92.8 and 83.5%. The 2- and 5-year overall survival rates were 82.1%. CONCLUSIONS: Endoscopic mucosal resection, endoscopic submucosal dissection and endoscopic laryngopharyngeal surgery-transoral pharyngectomies are useful procedures for treating superficial hypopharyngeal cancers. Endoscopic mucosal resection manifested the least invasiveness and may be beneficial for resecting small superficial lesions, endoscopic submucosal dissection may be advantageous for patients with difficult laryngopharyngeal exposure and endoscopic laryngopharyngeal surgery has shown the optimal effectiveness and minimal complications and can be applied to most of the hypopharyngeal sub-sites. All three procedures require a high level of technical skill and close collaboration between otolaryngologists and gastroenterologists.

Fascia implantation with fibroblast growth factor on vocal fold paralysis.

PURPOSE: The purpose of this prospective study was to determine the effect of autologous transplantation of fascia into the vocal fold (ATFV) with controlled release of basic fibroblast growth factor (bFGF) on unilateral vocal fold paralysis (UVFP) in a rat model. MATERIALS AND METHODS: Unilateral recurrent laryngeal nerve (RLN) section was performed on 15 rats. Ten rats received an autologous fascia implant and gelatin hydrogel with or without bFGF (1 µg) to their larynxes (fascia only, "fascia group"; bFGF + fascia, "fascia + bFGF group"), while the rest underwent RLN transection ("RLN section group"). Four months later, evaluation of the laryngeal glottal gap and histological analysis were performed. RESULTS: The glottal gap was significantly reduced in the fascia + bFGF group, and fat volume increased significantly relative to the RLN section. The volume of the remaining fascia in the bFGF + fascia group was significantly greater than that of the fascia group. CONCLUSIONS: ATFV with controlled release of bFGF may compensate for diminished laryngeal volume in UVFP by reducing resorption of the implanted fascia and increasing fat volume. Our findings suggest that this modality may represent an attractive option for treating UVFP.

Clinical outcome of supracricoid laryngectomy with cricohyoidoepiglottopexy: radiation failure versus previously untreated patients.

OBJECTIVE: A history of radiation therapy is known to be a major risk factor promoting post-surgical complications. By comparing the clinical outcomes of supracricoid laryngectomy with cricohyoidoepiglottopexy (SCL-CHEP) in irradiated and non-irradiated patients, we investigated the usefulness of salvage SCL-CHEP. METHODS: 73 patients who received SCL-CHEP between 1997 and 2010 (30 had received radiation therapy preoperatively and 43 had not). Staging error, wound infection, accuracy of surgical margin determination, acquired laryngeal function, and prognosis were compared between the two groups. RESULTS: Staging error occurred in 6/30 (20%) irradiated and 14/43 (33%) non-irradiated patients. An intraoperative margin study demonstrated a dysplastic or positive margin in 15/30 (50%) irradiated and 13/43 (30%) non-irradiated patients. Wound infection developed in 12/30 (40%) irradiated and 7/43 (16%) non-irradiated patients (P<0.05). Delayed wound infection was identified in four patients with a radiation dose over 65Gy. Swallowing function (ability to eat in public) was acquired in 28/30 (93%) irradiated and 39/43 (91%) non-irradiated patients. Five-year larynx preservation rates were 94% in irradiated and 91% in non-irradiated patients. Five-year overall survival rates were 81% in irradiated and 87% in non-irradiated patients. CONCLUSIONS: Risk of infection was significantly higher in irradiated patients; delayed infection should be appropriately managed. Functional and oncological results were stable regardless of radiation history. We encourage head and neck surgeons to take reasonable risks in performing salvage SCL-CHEP.

Buccal fat augmentation for insufficient neoglottal closure after supracricoid laryngectomy with cricohyoidoepiglottopexy.

OBJECTIVE: Supracricoid laryngectomy with Cricohyoidoepiglottopexy (SCL-CHEP) is a functional organ preservation surgery for laryngeal cancers. Post-operative laryngeal function is generally promising. Some patients, however, cannot attain satisfactory functional results because of an excessively wide neoglottis resulting in an insufficient neoglottal closure. Autologous buccal fat augmentation was conducted to correct the insufficiency. PATIENTS AND METHODS: Two patients underwent intervention. Under general anesthesia, autologous fat was harvested from the buccal fat pad. Fat tissue was injected into the widest plane of the neoglottis under direct laryngoscopy; a navigation system was incorporated to identify the responsible site. Acoustic, aerodynamic, and perceptual analyses along with videofluoroscopic swallowing study and screening questionnaires were used for functional evaluation. RESULTS: A total of 0.8ml (Case 1) and 0.7ml (Case 2) of fat tissues were injected into the submucosal space of the responsible sites. Both patients experienced functional improvement subjectively after augmentation; psychological parameters for voice and swallowing also improved. CONCLUSIONS: Buccal fat augmentation to correct insufficient neoglottal closure after SCL-CHEP was technically feasible. A navigation system was helpful for confirmation. Fat absorption occurred and one third of the volume remained at 3 and 6 months. Although, vocal measurements remained unchanged, psychological parameters for voice and swallowing improved.

Usefulness and pitfall of Narrow band imaging combined with magnifying endoscopy for detecting an unknown head and neck primary site with cervical lymph node metastasis.

OBJECTIVE: Cervical nodal metastasis from clinically undetectable primary squamous cell carcinoma (SCC) accounts for 1-2% of head and neck malignancies. We retrospectively evaluate the ability of Narrow band imaging combined with magnifying endoscopy (NBI-ME) to detect the primary sites of superficial SCC in the head and neck region. METHODS: This was a report of 11 patients. We performed with NBI-ME to detect unknown primary sites in the head and neck. RESULTS: Among 11 patients, primary sites were detected in eight. Primary sites were detected in the head and neck in 6 (54.5%) of 11 patients on NBI-ME, all 6 primary lesions were a flat lesion. Two patients in whom primary lesions could not be detected on NBI-ME, one had submucosal tumor like lesion, the other featured by a detectable primary lesion 19 months after neck dissection. CONCLUSION: NBI-ME can be recommended as an essential procedure for the detection of primary lesions in patients with primary unknown cervical lymph node metastasis.

Laminin-5 immunohistochemical mapping for analysis of local extension in hypopharyngeal cancer: A preliminary report.

OBJECTIVE: Laminin-5 γ2 chain (LNγ2) plays an important role in cancer differentiation and migration. Using a novel immunohistochemical mapping technique to investigate whole mucosal strips of total laryngopharyngectomy specimens using iodine, H-E, and LNγ2 stainings, we investigated the locoregional behavior of hypopharyngeal cancer. METHODS: Surgical specimens from two patients with pyriform sinus cancer were investigated. Three percent iodine was applied to the tumor-bearing laryngopharynx during surgery and photographed. Stainabilities of H-E and LNγ2 on pathologic sections from all mucosal strips were scored and coordinated with the laryngopharyngeal photograph to illustrate the immunohistochemical map. RESULTS: In both patients, the main tumor of invasive squamous cell carcinoma was circumferentially surrounded by a superficial lesion characterized by high grade intraepithelial neoplasia that remained unstained by iodine. On LNγ2 immunohistochemical mapping, the main tumor was demonstrated by Score 2 staining and the superficial lesion by a stronger Score 3 staining. CONCLUSIONS: The finding of neoplastic cells at the periphery demonstrating a higher potential than the cancer cells at the tumor center is suggestive of impending progression from neoplasia to carcinoma. The current preliminary report suggested morphological evidence of intraepithelial infiltration and lateral invasion in hypopharyngeal cancer.

Clinical significance of positive Delphian node in supracricoid laryngectomy with cricohyoidoepiglottopexy.

OBJECTIVE: A positive Delphian node is known to predict a poor prognosis in laryngeal cancer. To elucidate the clinical significance of positive Delphian node metastasis in supracricoid laryngectomized patients, we conducted a thorough clinical review. METHODS: We reviewed clinical data from 65 patients who underwent supracricoid laryngectomy with cricohyoidoepiglottopexy; in these patients, the Delphian node was examined by frozen section as a routine process. Incidence, positivity rates and clinical impact of the positive Delphian node were analyzed. RESULTS: The presence of the Delphian node was detected in 27 of 65 (41.5%) patients; among these 27 patients, 3 (3/65 = 4.6%) were positive for metastasis. Case 1 (pT3N2b) died of lung metastases 32 months after supracricoid laryngectomy with cricohyoidoepiglottopexy. Case 2 (pT4N2c) underwent conversion to total laryngectomy during supracricoid laryngectomy with cricohyoidoepiglottopexy because of unexpected submucosal lymphatic infiltration; this patient is currently alive with disease 23 months after surgery. Case 3 (T3N1) is currently alive without disease 48 months after surgery. CONCLUSIONS: The positive Delphian node is exclusively encountered in advanced laryngeal cancers and suggests an ominous outcome. Sufficient dissection of the paratracheal and lateral neck nodes is recommended. Delphian node evaluation is advised for all supracricoid laryngectomy surgeries.

Delayed wound infection after supracricoid partial laryngectomy following failure of high dose radiation.

Past radiation therapy is known as a major risk factor promoting post-supracricoid partial laryngectomy (SCPL) complications. Risk of post-SCPL complications may further increase following failure of high dose radiation; in these patients, wound infection may become evident more than 1 month after an uneventful post-surgical course. By defining this complication as "Delayed Wound Infection" and reviewing the clinical features, we intended to elucidate the mechanism, risk factors, and management of this post-SCPL complication. Between 1997 and 2009, 60 patients received SCPL. The incidence of post-SCPL wound infection was analyzed in reflect to radiation status, radiation dose, and medical histories. Of 60 patients, delayed wound infection was identified in 4 (7%); radiation doses were 65, 68, 70, and 76.8 Gy (avg. 70 Gy). Blood data including white blood cell and C-reactive protein showed slight elevation before the delayed infection became evident. Patients with high dose radiation (≥ 65 Gy) accompanied by histories of diabetes and renal insufficiency are considered a high risk group. Delayed re-epithelialization of the inner surface of the cricohyoido gap was presumed to be the main pathogenesis. Early initiation of antibiotics and hyperbaric oxygen therapy are effective for rapid recovery. "Delayed Wound Infection" was treatable and patients undergoing surgery after failure of high dose radiation should be managed with extra precaution, but should not be excluded from the indications for SCPL.

Clinical significance of intraoperative surgical margin study in supracricoid laryngectomy.

OBJECTIVE: Supracricoid laryngectomy (SCL) is a reliable procedure for laryngeal preservation. However, due to the limited anatomy of the larynx, close surgical margins are often inevitable. Although the usefulness of intraoperative margin study on frozen section has been well documented in laryngeal surgery, the clinical significance of margin study in SCL has not been clarified. This study evaluated the evidence base supporting margin study in SCL. METHODS: Between 1997 and 2009, 61 patients underwent SCL. Margin study was conducted by histopathologically examining surrounding mucosal strips between the resected laryngeal specimen and the residual larynx using frozen sections. The findings were analyzed in terms of pT staging and prognoses. RESULTS: Among all patients, pathological report indicated all negative in 36, dysplasia in 18, and positive findings in seven patients. Positive results were exclusively identified at the ipsilateral posterior and inferior margins. The incidence of local recurrence and death due to disease was slightly higher in patients with positive reports. The margin study influenced the intraoperative decision to convert from SCL to total laryngectomy in one case. CONCLUSIONS: In reviewing the margin study of 61 SCL patients, 11% resulted in positive margin. All except one patient with positive margin attained negative finding with additional samplings. Decision making regarding the resection margin can be difficult in patients with pT3-pT4 stages and postradiation status. Because of the exclusive identification of positive margin at the ipsilateral posterior and inferior edges, the margin study is strongly recommended at these sites. The possibility of converting SCL to TL should be discussed preoperatively during the informed consent process. The margin study is an effective modality for ensuring the validity of SCL and is recommended for all SCL procedures.