Thyroid CarcinomaNCT03500666
Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection
A study testing Robot and Total endoscopic in people with Thyroid Carcinoma and Robot Surgery, run by Fujian Medical University at 2 sites in China.
Trial summary
Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Carcinoma, Robot Surgery, Endoscopic Surgery
- What is being tested?
- Robot and Total endoscopic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis;
- patient's concerns of neck scars and cosmetic requirement.
- The exclusion criteria were as follows:
- 1) 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.
- 5）metastatic lymph nodes occurred below the sternoclavicular joint.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
bo wang, md, 13705947900, wangbo@fjmu.edu.cn
- Recruiting
Wen-xin ZHAO
Fuzhou, Fujian, 350001
Wen-xin ZHAO, MD, 8613365910359, zhaowx@fjmu.edu.cn
Bo WANG, MD, 8613705947900, wangbo@fjmu.edu.cn
About this study
Official title: A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection
Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.
Read the detailed description
To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.
- Conditions
- Thyroid Carcinoma, Robot Surgery, Endoscopic Surgery
- Being tested
- Robot, Total endoscopic
- Keywords
- Thyroid carcinoma, Robot surgery, Endoscopic surgery
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotDevice
Also called Robot lateral neck lymph node dissection
Robot lateral neck lymph node dissection
Total endoscopicDevice
Also called Total endoscopic lateral cervical lymph node dissection
Total endoscopic lateral cervical lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Total endoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During surgery
Accessory nerve injury
Accessory nerve injury
Measured: During surgery
Intraoperative internal jugular vein bleeding.
Internal carotid vein hemorrhage affect that surgical procedure
Measured: 6 months after surgery
Secondary outcomes (3)
The time of the thyroid gland removal
The time of the thyroid gland removal , including the opening of the white line to the thyroid, and the end of the specimen
Measured: During surgery
Number of participants with HypoParathyroidism
The parathyroid function was examined six months after surgery.
Measured: 6 months after surgery
Recurrent laryngeal nerve injury.
The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500666
- Sponsor's protocol ID
- BND and RND
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection
- ClinicalTrials.gov ID
- NCT03500666
- Acronym / sponsor ID
- BND and RND
- Conditions
- Thyroid Carcinoma, Robot Surgery, Endoscopic Surgery
- Keywords
- Thyroid carcinoma, Robot surgery, Endoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.
Detailed description
To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot lateral neck lymph node dissection | Experimental | Device: RobotRobot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis. |
| Total endoscopic lateral cervical lymph node dissection | Experimental | Device: Total endoscopicPatients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis;
- patient's concerns of neck scars and cosmetic requirement.
- 1) 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.
- 5）metastatic lymph nodes occurred below the sternoclavicular joint.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RobotAlso: Robot lateral neck lymph node dissectionRobot lateral neck lymph node dissection | Device | Robot lateral neck lymph node dissection |
| Total endoscopicAlso: Total endoscopic lateral cervical lymph node dissectionTotal endoscopic lateral cervical lymph node dissection | Device | Total endoscopic lateral cervical lymph node dissection |
Primary outcome
Lateral cervical lymph node cleaning time
Time frame: During surgery
Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen
Accessory nerve injury
Time frame: During surgery
Accessory nerve injury
Intraoperative internal jugular vein bleeding.
Time frame: 6 months after surgery
Internal carotid vein hemorrhage affect that surgical procedure
3 secondary outcomes
The time of the thyroid gland removal
Time frame: During surgery
Number of participants with HypoParathyroidism
Time frame: 6 months after surgery
Recurrent laryngeal nerve injury.
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot and Total endoscopic in people with Thyroid Carcinoma and Robot Surgery, run by Fujian Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral cervical lymph node cleaning time (time frame: During surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.