Submandibular Gland Preservation in Neck Dissection

NCT ID: NCT03385720

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Neck Dislocation Oral Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental group

Group Type EXPERIMENTAL

modified neck dissection

Intervention Type PROCEDURE

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

Control group

Group Type ACTIVE_COMPARATOR

traditional neck dissection

Intervention Type PROCEDURE

traditional neck dissection without preservation of submandibular gland

Interventions

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modified neck dissection

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

Intervention Type PROCEDURE

traditional neck dissection

traditional neck dissection without preservation of submandibular gland

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).

Exclusion Criteria

Cancer of the floor of the mouth.
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Peking University School of Stomatology

UNKNOWN

Sponsor Role collaborator

Guang-Yan Yu

OTHER

Sponsor Role lead

Responsible Party

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Guang-Yan Yu

President of Chinese Stomatological Association

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Peking University School of Stomatology

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jia-Zeng Su, Dr.

Role: CONTACT

86 10 82195992

Facility Contacts

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Guang-Yan Yu, Professor

Role: primary

86 10 13426227717

Other Identifiers

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sujiazeng

Identifier Type: -

Identifier Source: org_study_id

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