Clinical trial · Interventional
2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled Study
2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Many types of head and neck cancers will have local spread to the neck. As such selective neck dissection is performed as part of the treatment. The neck is divided into various levels. Selective neck dissection targets areas that are most likely to harbor cancer cells for specific types of head and neck cancers. Level IIB has been particularly controversial in the last few years, as the rate of cancer spread to this area has been shown to be quite low (0-8%). Moreover, because the spinal accessory nerve (involved in shoulder function) runs through this area, there is theoretical risk of causing post-operative shoulder weakness. As such, the question of whether removing level IIB, knowing that there is low chance of it containing disease spread, is worth risking decreased shoulder function. Some would argue that all potential diseased sites should be removed at all costs. While other advocate that a balance between disease cure and function should be maintained. However, what needs to be determined is just what impact does dissecting IIB have on shoulder function. At our institution, the rate of poor shoulder function associated with selective neck dissection has been perceived as being quite low. This study is designed to test this observation. Hypothesis: Neck dissection including level IIb in head and neck cancer patients will not lead to worse shoulder function and quality of life than when level IIb is preserved.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selective Neck Dissection Excluding Level 2B | Procedure | — | UNRESOLVED |
| Selective Neck Dissection Including Level 2B | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1 (Not 2B)
- description
- Selective neck dissection is performed on the dominant arm. Level 2B is not dissected.
- interventionNames
- Procedure: Selective Neck Dissection Excluding Level 2B
- type
- ACTIVE_COMPARATOR
- label
- Group 2 (2B)
- description
- Selective neck dissection is performed on the dominant arm. Level 2B is dissected.
- interventionNames
- Procedure: Selective Neck Dissection Including Level 2B
Primary outcomes (1)
- measure
- Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Head and neck cancer to be treated with primary surgical resection, SND and post-operative radiation therapy (RT). 2. N0 neck disease on side of the dominant hand 3. Willingness to participate in post-operative physiotherapy Exclusion Criteria: 1. IIb positive disease found on clinical exam, CT Scan or intraoperatively (gross appearance or positive margins of frozen section of level IIa) 2. Previous neck RT 3. Previous chemotherapy 4. Invasion of spinal accessory nerve (SAN) by neck malignancy (evident on physical exam, CT scan or intraoperatively (gross appearance). 5. Previous neck dissection 6. Previous SAN injury or dysfunction 7. Preoperative signs or formal diagnosis of myopathy or neuropathy 8. Previous shoulder injury (muscular or bony) 9. Level V neck dissection 10. Recognized intraoperative sectioning of the SAN 11. Unable to provide informed consent 12. Cardiac pacemaker (contra-indication to EMG/Nerve conduction) 13. Radial forearm free flap on dominant arm
References
Publications (7)
- BACKGROUNDAmbrosch P, Kron M, Pradier O, Steiner W. Efficacy of selective neck dissection: a review of 503 cases of elective and therapeutic treatment of the neck in squamous cell carcinoma of the upper aerodigestive tract. Otolaryngol Head Neck Surg. 2001 Feb;124(2):180-7. doi: 10.1067/mhn.2001.111598. PMID 11226954
- BACKGROUNDCappiello J, Piazza C, Giudice M, De Maria G, Nicolai P. Shoulder disability after different selective neck dissections (levels II-IV versus levels II-V): a comparative study. Laryngoscope. 2005 Feb;115(2):259-63. doi: 10.1097/01.mlg.0000154729.31281.da. PMID 15689746
- BACKGROUNDSmith R, Taylor SM, Trites JR, Smith A. Patterns of lymph node metastases to the submuscular recess. J Otolaryngol. 2007 Aug;36(4):203-7. doi: 10.2310/7070.2007.0033. PMID 17942033
- BACKGROUNDSilverman DA, El-Hajj M, Strome S, Esclamado RM. Prevalence of nodal metastases in the submuscular recess (level IIb) during selective neck dissection. Arch Otolaryngol Head Neck Surg. 2003 Jul;129(7):724-8. doi: 10.1001/archotol.129.7.724. PMID 12874072
- BACKGROUNDPaleri V, Kumar Subramaniam S, Oozeer N, Rees G, Krishnan S. Dissection of the submuscular recess (sublevel IIb) in squamous cell cancer of the upper aerodigestive tract: prospective study and systematic review of the literature. Head Neck. 2008 Feb;30(2):194-200. doi: 10.1002/hed.20682. PMID 17712854
- BACKGROUNDTalmi YP, Hoffman HT, Horowitz Z, McCulloch TM, Funk GF, Graham SM, Peleg M, Yahalom R, Teicher S, Kronenberg J. Patterns of metastases to the upper jugular lymph nodes (the "submuscular recess"). Head Neck. 1998 Dec;20(8):682-6. doi: 10.1002/(sici)1097-0347(199812)20:83.0.co;2-j. PMID 9790288
- DERIVEDDziegielewski PT, McNeely ML, Ashworth N, O'Connell DA, Barber B, Courneya KS, Debenham BJ, Seikaly H. 2b or not 2b? Shoulder function after level 2b neck dissection: A double-blind randomized controlled clinical trial. Cancer. 2020 Apr 1;126(7):1492-1501. doi: 10.1002/cncr.32681. Epub 2019 Dec 24.