2b or not 2b? Shoulder function after level 2b neck dissection: A double‐blind randomized controlled clinical trial

Abstract

Background Selective neck dissection (SND) is a mainstay of head and neck cancer treatment. A common sequela is shoulder syndrome from spinal accessory nerve (SAN) trauma. Extensive dissection in neck levels 2 and 5 leads to SAN dysfunction. However, it is not known whether limited level 2 dissection reduces SAN injury. The purpose of this double‐blind randomized controlled trial was to determine whether omitting level 2b dissection would improve shoulder‐related quality of life and function. Methods Patients with head and neck cancers undergoing surgery were randomized 1:1 to SND without level 2b dissection (group 1) or with it (group 2) on their dominant‐hand side. Patients, caregivers, and assessors were blinded. The primary outcome was the change in the Neck Dissection Impairment Index (NDII) score after 6 months. An a priori calculation of the minimally important clinical difference in the NDII score was determined to establish a sample size of 15 patients per group (power = 0.8). Secondary outcomes included shoulder strength and range of motion (ROM) and SAN nerve conduction. The trial was registered at ClinicalTrials.gov (NCT00765791). Results Forty patients were enrolled, and 30 were included (15 per group). Six months after the surgery, group 2 demonstrated a significant median decrease in the NDII from the baseline (30 points) and in comparison with group 1, whose NDII dropped 17.5 points (P = .02). Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P ≤ .05). No adverse events occurred. Conclusions Level 2b should be omitted in SND when this is oncologically safe and feasible. This allows for an optimal balance between function and cancer cure.

Rational surgical neck management in total laryngectomy for advanced stage laryngeal squamous cell carcinomas

“…A recent randomized-controlled clinical trial has shown that omitting level IIB in elective SND is safe and is accompanied by decreased shoulder function impairment and increased quality of life, while a significant reduction in operating time was also observed. In that study, only one case of laryngeal squamous cell carcinoma was included in the 'not dissected' IIB group (Dziegielewski et al 2019). Similar conclusions were made by a Japanese group who concluded that level IIB dissection in HNSCC was only necessary in cases where preoperative examination revealed multi-level or level IIA metastases or suspected level IIB metastases (Hosokawa et al 2019).…”

“…A recent work suggested that concurrent neck dissection was not associated with increased morbidity in TL procedures (Xiao et al 2019), which leaves the authors of this study in some doubt when recalling the rates of postoperative complications detected in earlier studies mentioned above including a randomized clinical trial (Dziegielewski et al 2019).…”

Preservation of spinal accessory and level 2b–sparing neck dissection: The balance beyond oncology and functionality

“…We applaud Dziegielewski et al for meticulously collating an arduous trial, pointing out subtle details and generating a high level of evidence supporting the occurrence of shoulder dysfunction in patients undergoing submuscular recess dissections. 1 Although the literature supporting the omission of level 2b is fractionated, 2 to our knowledge studies have failed to provide concrete evidence with regard to oncological safety and long-term shoulder dysfunction in avoiding submuscular recess dissection. 3,4 Studies till date have indicated that there may be functional disability associated with any type of neck dissection.…”

“…Evidence currently is divided regarding the role of the omission of level 2b based on arguable oncological safety. The study by Dziegielewski et al 1 , through an exemplary model, has emphasized the importance of the SAN in improving functional outcomes. However, the results of the study have to be considered in light of a low sample size and multiple anatomical locations of head and neck squamous cell carcinoma.…”

“…We thank Reddy et al for their interest in our study. 1 Their comments come at a time when head and neck surgeons strive to maximize functional outcomes while preserving survival rates. In so doing, many of us debate the inclusion of level 2b in a selective neck dissection (SND).…”