Trial of IIb Preserving Neck Dissection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Banaras Hindu University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00847717
First received: February 18, 2009
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Oral Cancer
Procedure: Selective neck dissection
Procedure: Conventional Neck dissection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • Spinal accessary nerve function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neck Node failure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2007
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IIb preserving neck dissection
Procedure: Selective neck dissection
Level IIb preserving neck dissection
2
Conventional neck dissection
Procedure: Conventional Neck dissection
Conventional neck dissection (MRND type III or Supraomohyoid)

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847717

Contacts
Contact: Manoj Pandey, MS +91-542-2309511 manojpandey@vsnl.com

Locations
India
Banaras Hindu University Recruiting
Varanasi, UP, India, 221005
Contact: Manoj Pandey, MS    +91-542-2309511    manojpandey@vsnl.com   
Principal Investigator: Manoj Pandey, MS         
Sub-Investigator: Deepika Joshi, MD, DM         
Sub-Investigator: Mohan Kumar, MD         
Sponsors and Collaborators
Banaras Hindu University
Investigators
Principal Investigator: Manoj Pandey, MS Banaras Hindu University
  More Information

Publications:
Responsible Party: Dr. Manoj Pandey, Head, Banaras Hindu University
ClinicalTrials.gov Identifier: NCT00847717     History of Changes
Other Study ID Numbers: SND_01
Study First Received: February 18, 2009
Last Updated: August 10, 2009
Health Authority: India: Institutional Review Board

Keywords provided by Banaras Hindu University:
Oral
cancer
surgery
neck dissection
spinal accessory nerve

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 15, 2014