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Recruiting Not applicable

Submandibular Gland Preservation in Neck Dissection

NCT03385720 · tracked via the Priya Life Science China tracker
Sponsor
Guang-Yan Yu
Phase
Not applicable
Started
2017-12-05
Last updated
2023-03-30

Condition(s) studied

Neck DislocationOral Cancer

Investigational drug(s) / intervention(s)

modified neck dissectiontraditional neck dissection

modified neck dissection: Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.

traditional neck dissection: traditional neck dissection without preservation of submandibular gland

Study summary

Trial design: a randomized controlled trial.

Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.

Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.

Primary Parameters: survival rate, mortality rate

Eligibility

Sex
ALL
Min age
—
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0). Exclusion Criteria: Cancer of the floor of the mouth.

Primary outcome measure(s)

  • 5-year survival rate — 5-year after operation
    disease free survival rate
  • 3-year survival rate — 3-year after operation
    disease free survival rate
  • 5-year regional recurrence rate — 5-year after operation
    rate of participants with tumor recurrence in the neck
  • 3-year regional recurrence rate — 3-year after operation
    rate of participants with tumor recurrence in the neck
  • 1-year regional recurrence rate — 1-year after operation
    rate of participants with tumor recurrence in the neck

Trial sites (1)

FacilityCityRegionStatus
Peking University School of Stomatology Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03385720 on ClinicalTrials.gov ↗ ← All trials in China