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Trial of IIb Preserving Neck Dissection

Primary Purpose

Oral Cancer

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Selective neck dissection
Conventional Neck dissection
Sponsored by
Banaras Hindu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cancer focused on measuring Oral, cancer, surgery, neck dissection, spinal accessory nerve

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banaras Hindu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

IIb preserving neck dissection

Conventional neck dissection

Outcomes

Primary Outcome Measures

Spinal accessary nerve function

Secondary Outcome Measures

neck Node failure

Full Information

First Posted
February 18, 2009
Last Updated
July 14, 2018
Sponsor
Banaras Hindu University
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1. Study Identification

Unique Protocol Identification Number
NCT00847717
Brief Title
Trial of IIb Preserving Neck Dissection
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Banaras Hindu University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
Oral, cancer, surgery, neck dissection, spinal accessory nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
IIb preserving neck dissection
Arm Title
2
Arm Type
Other
Arm Description
Conventional neck dissection
Intervention Type
Procedure
Intervention Name(s)
Selective neck dissection
Intervention Description
Level IIb preserving neck dissection
Intervention Type
Procedure
Intervention Name(s)
Conventional Neck dissection
Intervention Description
Conventional neck dissection (MRND type III or Supraomohyoid)
Primary Outcome Measure Information:
Title
Spinal accessary nerve function
Time Frame
2 years
Secondary Outcome Measure Information:
Title
neck Node failure
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Pandey, MS
Organizational Affiliation
Banaras Hindu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banaras Hindu University
City
Varanasi
State/Province
UP
ZIP/Postal Code
221005
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
15523444
Citation
Coskun HH, Erisen L, Basut O. Selective neck dissection for clinically N0 neck in laryngeal cancer: is dissection of level IIb necessary? Otolaryngol Head Neck Surg. 2004 Nov;131(5):655-9. doi: 10.1016/j.otohns.2004.04.014.
Results Reference
background
PubMed Identifier
16301367
Citation
Robbins KT, Doweck I, Samant S, Vieira F. Effectiveness of superselective and selective neck dissection for advanced nodal metastases after chemoradiation. Arch Otolaryngol Head Neck Surg. 2005 Nov;131(11):965-9. doi: 10.1001/archotol.131.11.965.
Results Reference
background
PubMed Identifier
17040583
Citation
Orhan KS, Demirel T, Baslo B, Orhan EK, Yucel EA, Guldiken Y, Deger K. Spinal accessory nerve function after neck dissections. J Laryngol Otol. 2007 Jan;121(1):44-8. doi: 10.1017/S0022215106002052. Epub 2006 Jul 3.
Results Reference
background
PubMed Identifier
12818606
Citation
van Wilgen CP, Dijkstra PU, Nauta JM, Vermey A, Roodenburg JL. Shoulder pain and disability in daily life, following supraomohyoid neck dissection: a pilot study. J Craniomaxillofac Surg. 2003 Jun;31(3):183-6. doi: 10.1016/s1010-5182(03)00030-1.
Results Reference
background
PubMed Identifier
11784253
Citation
Taylor RJ, Chepeha JC, Teknos TN, Bradford CR, Sharma PK, Terrell JE, Hogikyan ND, Wolf GT, Chepeha DB. Development and validation of the neck dissection impairment index: a quality of life measure. Arch Otolaryngol Head Neck Surg. 2002 Jan;128(1):44-9. doi: 10.1001/archotol.128.1.44.
Results Reference
background
PubMed Identifier
30409212
Citation
Pandey M, Karthikeyan S, Joshi D, Kumar M, Shukla M. Results of a randomized controlled trial of level IIb preserving neck dissection in clinically node-negative squamous carcinoma of the oral cavity. World J Surg Oncol. 2018 Nov 8;16(1):219. doi: 10.1186/s12957-018-1518-z.
Results Reference
derived

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Trial of IIb Preserving Neck Dissection

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