Submandibular Gland-Sparing Technique Versus En-Bloc Level IB Dissection in Oral Cavity Cancers with N0 Neck Status: A Randomized Controlled Trial.

IF 2.6 3区医学 Q1 OTORHINOLARYNGOLOGY

Journal of Otolaryngology - Head & Neck Surgery Pub Date : 2024-01-01 DOI:10.1177/19160216241300069

G Vetrivel, Areej Moideen, Bhinyaram Jat, Prashant Durgapal, Amit Kumar, Amit Kumar Tyagi, Sourabha Kumar Patro, Kinjal Shankar Majumdar, Vikramjit Singh, Nivedhan Ravichandran, Ankita Semwal, Rachit Sood, Ashutosh Hota, Akhilesh Chandra Yadav, M Ramesh Prasath

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引用次数: 0

Abstract

Importance: Metastases to the submandibular gland (SMG) from oral cavity primaries are very rare. Hence, a gland-preserving level IB dissection technique is a feasible option without compromising the lymph node yield (LNY).

Objective: To assess the feasibility and noninferiority of the SMG-preserving dissection technique to the conventional en bloc removal of level IB in terms of LNY in patients with cN0 oral squamous cell carcinoma (OSCC) undergoing elective neck dissection.

Design: Parallel-design, single-center, open-label, randomized controlled trial.

Setting: Tertiary care health care center-Department of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh.

Participants: Thirty-eight (n = 38) participants with 46 (n = 46) neck dissection specimens of OSCC were randomly allocated (1:1) into gland-preserving (n₁ = 23) and en bloc (n₂ = 23) dissection groups.

Intervention: Elective neck dissection comparing SMG-sparing level IB dissection technique versus en bloc level IB dissection.

Main outcome measures: LNY, lymph node density, and level IB operative time in both groups were compared between groups (α < .05).

Results: Median LNY (P = .543) and lymph node density (P = 1.000) in level IB did not show significant differences between the groups. LNY in level IB by gland-preserving technique is also not inferior to the conventional en bloc dissection technique (mean difference = 0.217; 95% CI: [-0.597, 1.032]; P = .593). The mean level IB operative time is significantly longer in the gland-preserving group (P < .001).

Conclusions and relevance: None of the examined SMGs were involved by the tumor. SMG-preserving technique is noninferior to the traditional technique of level IB clearance and can be used in elective neck dissections without compromising the LNY. Functional neck dissection has greatly evolved to decrease patient morbidity, and this method can be adopted in case-specific situations.

Trial registration: The trial was registered in the Clinical Trials Registry-India (CTRI/2022/05/042344) on May 2, 2023, https://ctri.nic.in/.

查看原文本刊更多论文

N0颈部状态口腔癌的下颌下腺剥离技术与En-Bloc IB层切除术：随机对照试验

重要性：口腔原发癌转移至颌下腺（SMG）的情况非常罕见。因此，保留腺体的 IB 层清扫技术是一种可行的选择，且不会影响淋巴结产量（LNY）：目的：评估在接受择期颈部清扫术的 cN0 口腔鳞状细胞癌（OSCC）患者中，保留 SMG 的清扫术与传统的 IB 级整体切除术在淋巴结产量方面的可行性和非劣效性：平行设计、单中心、开放标签、随机对照试验：三级医疗保健中心：AIIMS 瑞诗凯诗耳鼻咽喉头颈外科：38名（n = 38）参与者的46份（n = 46）OSCC颈部切除标本被随机分配（1:1）到保留腺体组（n1 = 23）和整体切除组（n2 = 23）：干预措施：选择性颈部解剖，比较SMG保留IB层解剖技术与整体IB层解剖：比较两组的 LNY、淋巴结密度和 IB 层手术时间（α 结果：IB 层淋巴结中位数（P = .543）和淋巴结密度（P = 1.000）在两组间无显著差异。保留腺体技术的 IB 层淋巴结清扫术也不逊色于传统的整体清扫术（平均差异 = 0.217; 95% CI: [-0.597, 1.032]; P = .593）。保留腺体组的 IB 平均手术时间明显更长（P 结论和相关性：所有受检的 SMG 均未受肿瘤累及。保留 SMG 的技术并不比传统的 IB 层清扫技术差，可用于择期颈部解剖而不影响 LNY。功能性颈部切除术的发展大大降低了患者的发病率，这种方法可根据具体情况采用：该试验于2023年5月2日在印度临床试验注册中心注册（CTRI/2022/05/042344），https://ctri.nic.in/。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Otolaryngology - Head & Neck Surgery 医学-耳鼻喉科学

CiteScore

6.50

自引率

2.90%

发文量

审稿时长

6 weeks

期刊介绍： Journal of Otolaryngology-Head & Neck Surgery is an open access, peer-reviewed journal publishing on all aspects and sub-specialties of otolaryngology-head & neck surgery, including pediatric and geriatric otolaryngology, rhinology & anterior skull base surgery, otology/neurotology, facial plastic & reconstructive surgery, head & neck oncology, and maxillofacial rehabilitation, as well as a broad range of related topics.