NCT03500666

Brief Summary

Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

April 2, 2018

Last Update Submit

April 15, 2018

Conditions

Thyroid CarcinomaRobot SurgeryEndoscopic Surgery

Keywords

Thyroid carcinomaRobot surgeryEndoscopic surgery

Outcome Measures

Primary Outcomes (3)

  • Lateral cervical lymph node cleaning time

    Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen

    During surgery

  • Accessory nerve injury

    Accessory nerve injury

    During surgery

  • Intraoperative internal jugular vein bleeding.

    Internal carotid vein hemorrhage affect that surgical procedure

    6 months after surgery

Secondary Outcomes (3)

  • The time of the thyroid gland removal

    During surgery

  • Number of participants with HypoParathyroidism

    6 months after surgery

  • Recurrent laryngeal nerve injury.

    6 months after surgery

Study Arms (2)

Robot lateral neck lymph node dissection

EXPERIMENTAL

Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis.

Device: Robot

Total endoscopic lateral cervical lymph node dissection

EXPERIMENTAL

Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection.

Device: Total endoscopic

Interventions

RobotDEVICE

Robot lateral neck lymph node dissection

Also known as: Robot lateral neck lymph node dissection
Robot lateral neck lymph node dissection
Total endoscopicDEVICE

Total endoscopic lateral cervical lymph node dissection

Also known as: Total endoscopic lateral cervical lymph node dissection
Total endoscopic lateral cervical lymph node dissection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis;
  • patient's concerns of neck scars and cosmetic requirement.

You may not qualify if:

  • \) tumor size \>4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve.
  • ）metastatic lymph nodes occurred below the sternoclavicular joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Wen-xin ZHAO

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 18, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)