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Trial of IIb Preserving Neck Dissection

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ClinicalTrials.gov Identifier: NCT00847717
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Manoj Pandey, Banaras Hindu University

Tracking Information
First Submitted Date  ICMJE February 18, 2009
First Posted Date  ICMJE February 19, 2009
Last Update Posted Date July 17, 2018
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
Spinal accessary nerve function [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
neck Node failure [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of IIb Preserving Neck Dissection
Official Title  ICMJE Randomized Controlled Trial of IIb Preserving Neck Dissection VS Neck Dissections Involving IIb Removal (Selective/Functional) in Patients With N0 Neck With Oral Cavity Malignancies
Brief Summary

The treatment of clinically N0 neck in malignancies of oral cavity is controversial. The options include the policy of "wait and watch"(close observation and follow-up), elective irradiation of the neck, elective surgery of the neck (neck dissection).

In elective neck dissections, the procedures commonly performed are modified radical neck dissection-III (functional neck dissection) and selective (supraomohyoid) neck dissection depending on the site of the primary lesion within the oral cavity. There are no trials of IIb preserving neck dissection in cancers of the oral cavity.

Detailed Description

Surgery of the cervical lymphatic system has evolved a lot since the introduction of classical radical neck dissection by Crile in 1906, which was later established by Martin (1945). It includes the removal of cervical lymphatic levels I-V along with removal of non-lymphatic structures namely submandibular gland, tail of parotid, omohyoid muscle, cervical plexus of nerves, spinal accessory nerve, internal jugular vein and sternocleidomastoid muscle. The main morbidity of the radical neck dissection was the trapezius muscle dysfunction with shoulder drop, resulting in pain and shoulder dysfunction. The other morbidities of radical neck dissection were cosmetic deformity of neck, painful neuromas, increased facial swelling, numbness of neck and ear.

In the last three decades, many modifications of the classical radical neck dissection (modified radical neck dissections), had been described and are increasingly applied. The main modifications have been the preservation of one or more of the non-lymphatic structures that were removed in classical radical neck dissection mainly the spinal accessory nerve, internal jugular vein, sternocleidomastoid muscle (Bocca and Pignataro, 1967). The reasons for developing these modifications were functional and cosmetic, while preserving the oncological safety of the procedure.

Much later in 1980s, the concept of selective neck dissection, for which Lindberg (1972) and Skolnik (1976) laid down important basis, was introduced. In selective neck dissections only those groups of lymph nodes are removed, which, depending upon the location of the primary tumour, are most likely to contain metastasis (Shah, 1990).

The first selective neck dissection introduced was the supraomohyoid neck dissection, which includes the removal of lymph node levels I-III, while preserving the non-lymphatic structures as functional neck dissection. Medina and Byers in a prospective study have demonstrated the utility of this supraomohyoid neck dissection in patients with clinically negative neck nodes (N0) with malignancies of oral cavity.

The posterolateral neck dissection removes lymph node levels II-V as well as retroauricular and suboccipital nodes, which is used primarily for treatment of tumours of scalp and post auricular skin.

The lateral neck dissection, which includes removal of lymph node levels II-IV, is done for tumours of larynx or hypopharynx with N0 neck.

The anterior compartment neck dissection includes removal of only lymph node level VI which is done in thyroid malignancies when there is no evidence of lateral lymphadenopathy, and is combined with lateral neck dissection(anterolateral) if there are lymphnodes involved.

Recently the concept of superselective neck dissections has been introduced. It is less radical than selective neck dissections, removing lesser number of at-risk lymph nodal groups.

H Coskun (2004) found IIb preserving superselective neck dissection as oncologically safe procedure in N0 laryngeal cancer, with more functional preservation of trapezius muscle and hence negligible shoulder disability. In this study, it was found that even in selective neck dissection, some degree of spinal accessory nerve dysfunction and shoulder disability occurs as a result of retraction of the nerve during the clearance of the lymph nodes posterior and superior to the nerve (IIb). If these lymph nodes were not removed and left in place, there would be no stretching of spinal accessory nerve during the neck dissection and shoulder disability could be avoided

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oral Cancer
Intervention  ICMJE
  • Procedure: Selective neck dissection
    Level IIb preserving neck dissection
  • Procedure: Conventional Neck dissection
    Conventional neck dissection (MRND type III or Supraomohyoid)
Study Arms  ICMJE
  • Experimental: 1
    IIb preserving neck dissection
    Intervention: Procedure: Selective neck dissection
  • 2
    Conventional neck dissection
    Intervention: Procedure: Conventional Neck dissection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2009)
100
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients >18yrs of age.
  • histologically proven squamous cell carcinoma
  • clinical and radiological N0 neck

Exclusion Criteria:

  • Pregnant and lactating women

    • Patients with synchronous primaries
  • H/o previous malignancy except BCC
  • Previous surgeries on neck

    • Post radiotherapy recurrence.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00847717
Other Study ID Numbers  ICMJE SND_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Manoj Pandey, Banaras Hindu University
Original Responsible Party Dr. Manoj Pandey, Head, Banaras Hindu University
Current Study Sponsor  ICMJE Banaras Hindu University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manoj Pandey, MS Banaras Hindu University
PRS Account Banaras Hindu University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP