Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00728130
Recruitment Status : Completed
First Posted : August 5, 2008
Results First Posted : July 29, 2013
Last Update Posted : January 5, 2015
Information provided by (Responsible Party):
Southern Illinois University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma
Intervention: Procedure: neck dissection of at least the ipsilateral sub-level 1B

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Treatment planning was performed for all patients in the multidisciplinary head and neck oncology forum before recruitment into the trial.

Dates of recruitment: 06/11/2008 through 09/17/2009 Number of patients recruited: 23 Number of patient completing trial: 20

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Surgery A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.

Participant Flow:   Overall Study
Withdrawal by Subject                1 
Paperwork not completed in time                1 
Physician Decision                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Surgery A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 56.5  (10.8) 
Age, Customized 
[Units: Participants]
<=18 years   0 
Between 18 and 79 years   22 
>=80 years   0 
[Units: Participants]
Female   8 
Male   14 
submandibular gland excision 
[Units: Participants]
Surgery   19 
Not completed   3 
sublevel IB dissection 
[Units: Participants]
Surgery   19 
Not completed   3 
surgical bed inspection 
[Units: Participants]
Surgery   19 
Not completed   3 

  Outcome Measures

1.  Primary:   the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.   [ Time Frame: Post Surgical Time point ]

2.  Secondary:   The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.   [ Time Frame: Post surgical time point ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Simmons Cancer Institute at Southern Illinois University School of Medicine
phone: 217-545-1946


Responsible Party: Southern Illinois University Identifier: NCT00728130     History of Changes
Other Study ID Numbers: RON-SCCI 08-003-1
First Submitted: July 31, 2008
First Posted: August 5, 2008
Results First Submitted: May 29, 2013
Results First Posted: July 29, 2013
Last Update Posted: January 5, 2015