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2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled Study

NCT00765791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-09

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Selective Neck Dissection Excluding Level 2B

Selective neck dissection is performed. Level 2a is dissected; level 2b is not dissected.

PROCEDURE

Selective Neck Dissection Including Level 2B

Selective neck dissection is performed. Level 2a is dissected; level 2b is also dissected.

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Hadi R Seikaly, MD, FRCSC · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-06-30
Completion
2017-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00765791 on ClinicalTrials.gov