Lymph Node DissectionNCT03845647
Significance of Contralateral Central Lymph Node Dissection in Unilateral cN0 Differentiated Thyroid Carcinoma.
A study testing contralateral central lymph node dissection in people with Lymph Node Dissection and Lymph Node Metastases, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
There are so many contradictions over central lymph node dissection in unilateral cN0(Clinically N0) differentiated thyroid carcinoma.In order to provides a new theoretical basis for the operation of central lymph node in cN0(Clinically N0) differentiated thyroid cancer,researchers are going to complete this study to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymph Node Dissection, Lymph Node Metastases, Differentiated Thyroid Carcinoma
- What is being tested?
- contralateral central lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 28 Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accurately diagnosing primary differentiated thyroid carcinoma according to pathological diagnostic criteria .
- Differentiated thyroid carcinoma with cN0(Clinically N0) was diagnosed by thyroid ultrasound text and/or neck CT,and was confirmed with differentiated thyroid carcinoma by postoperative pathological examination.
- The age is more than 18 years old and less than 65 years old. There is no gender restriction.
- Untreated patients who have not received surgery, interventional therapy,chemotherapy, biotherapy, and radiation therapy.
- Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white blood cell count≥ 4 × 109/ L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min.
- Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent.
Who cannot join
- • ①Bilateral DTC(differentiated thyroid cancer) patients ②Non-DTC(differentiated thyroid cancer)patients ③ Non-cn0(Clinically N0) patients ④ cN0(Clinically N0) patients but could not be operated on.
- Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL). In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women.
- Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot be corrected by treatment with vitamin K, etc.).
- Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate.
- People with severe emphysema, pulmonary congestion, and pulmonary heart disease.
- Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fifth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Qingan Zeng, doctor, 0756-2528810, zengqa1218@126.com
About this study
Official title: Significance of Single Center, Open and Prospective Evaluation of Contralateral Central Lymph Node Dissection in Unilateral cN0 Differentiated Thyroid Carcinoma.
There are so many contradictions over central lymph node dissection in unilateral cN0(Clinically N0) differentiated thyroid carcinoma.In order to provides a new theoretical basis for the operation of central lymph node in cN0(Clinically N0) differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0(Clinically N0) differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer.
Read the detailed description
Being the most common thyroid malignant tumor,differentiated thyroid carcinoma often metastasize to the neck lymph nodes in the early stage,especially to the central lymph node.For management of cervical lymph nodes ,the 2015 American Thyroid Association Management Guidelines suggest that thyroid+Prophylactic unilateral or bilateral central lymph node dissection should be undertaken in the patients with cN0(Clinically N0) progression (T3, T4) and cN1b(Clinically N1b).Chinese guidelines recommend that, in order to avoid operative complications as far as possible (i.e. effective protection of the parathyroid gland and recurrent laryngeal nerve), lymph node dissection in the central area on the same side of the lesion should be performed at least.However, in 2017, the second edition of National Comprehensive Cancer Network(NCCN) thyroid tumor guidelines believed that if lymph nodes in the central region were negative,preventive central region lymph node dissection was not recommended.In conclusion,there are so many contradictions over central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.However,we also can draw a conclusion that it may bring some benefits if bilateral central lymph node dissection were undertaken In some cases.According to researchers' preliminary clinical trials,it is not only that there is a great probability of metastasis in the ipsilateral central lymph nodes , contralateral metastasis is also possible,and even sometimes contralateral central lymph region metastas may occur without ipsilateral central lymph nodes metastasis.In order to provides a new theoretical basis for the operation of central lymph node in cN0 differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer.
- Being tested
- contralateral central lymph node dissection
- Keywords
- lymph node dissection, differentiated thyroid carcinoma
- Medical subject headings
- Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contralateral central lymph node dissectionProcedure or surgery
contralateral central lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Tumor diameter<=2cm study group | Experimental | In order to provides a new theoretical basis for the operation of central lymph node in cN0 differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer. Receives: Procedure: contralateral central lymph node dissection |
| Tumor diameter>2cm study group | Experimental | In order to provides a new theoretical basis for the operation of central lymph node in cN0(Clinically N0) differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer. Receives: Procedure: contralateral central lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor diameter
Tumor diameter will be measured by postoperative pathological examination.
Measured: 12 months
Number of lymph nodes dissected in every side of central lymph node
Count the number of lymph nodes dissected during operation in every side of central lymph nodes of every Participants.
Measured: 12 months
Number of metastatic lymph nodes diagnosed by Postoperative pathology
Count the number of metastatic lymph nodes diagnosed by Postoperative pathology in every side of central lymph nodes of every Participants.
Measured: 12 months
Secondary outcomes (1)
Rate of lymph nodes metastasis
Based on the statistics of Primary Outcome,count the rate of lymph node metastasis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Feb 2019
- Primary completion28 Dec 2020 (estimated)
- Study completion28 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node DissectionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845647
- Sponsor's protocol ID
- ZDWY.JRWK.002
- Status last verified
- Nov 2019
- First submitted
- 17 Feb 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Single Center, Open and Prospective Evaluation of Contralateral Central Lymph Node Dissection in Unilateral cN0 Differentiated Thyroid Carcinoma.
- ClinicalTrials.gov ID
- NCT03845647
- Acronym / sponsor ID
- ZDWY.JRWK.002
- Keywords
- lymph node dissection, differentiated thyroid carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Dec 2020 (estimated)
- Study completion
- 28 Dec 2020 (estimated)
- First posted
- 19 Feb 2019 (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.
There are so many contradictions over central lymph node dissection in unilateral cN0(Clinically N0) differentiated thyroid carcinoma.In order to provides a new theoretical basis for the operation of central lymph node in cN0(Clinically N0) differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0(Clinically N0) differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer.
Detailed description
Being the most common thyroid malignant tumor,differentiated thyroid carcinoma often metastasize to the neck lymph nodes in the early stage,especially to the central lymph node.For management of cervical lymph nodes ,the 2015 American Thyroid Association Management Guidelines suggest that thyroid+Prophylactic unilateral or bilateral central lymph node dissection should be undertaken in the patients with cN0(Clinically N0) progression (T3, T4) and cN1b(Clinically N1b).Chinese guidelines recommend that, in order to avoid operative complications as far as possible (i.e. effective protection of the parathyroid gland and recurrent laryngeal nerve), lymph node dissection in the central area on the same side of the lesion should be performed at least.However, in 2017, the second edition of National Comprehensive Cancer Network(NCCN) thyroid tumor guidelines believed that if lymph nodes in the central region were negative,preventive central region lymph node dissection was not recommended.In conclusion,there are so many contradictions over central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.However,we also can draw a conclusion that it may bring some benefits if bilateral central lymph node dissection were undertaken In some cases.According to researchers' preliminary clinical trials,it is not only that there is a great probability of metastasis in the ipsilateral central lymph nodes , contralateral metastasis is also possible,and even sometimes contralateral central lymph region metastas may occur without ipsilateral central lymph nodes metastasis.In order to provides a new theoretical basis for the operation of central lymph node in cN0 differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor diameter<=2cm study group | Experimental | Procedure: contralateral central lymph node dissectionIn order to provides a new theoretical basis for the operation of central lymph node in cN0 differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer. |
| Tumor diameter>2cm study group | Experimental | Procedure: contralateral central lymph node dissectionIn order to provides a new theoretical basis for the operation of central lymph node in cN0(Clinically N0) differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Accurately diagnosing primary differentiated thyroid carcinoma according to pathological diagnostic criteria .
Key exclusion criteria (6 listed)
- • ①Bilateral DTC(differentiated thyroid cancer) patients ②Non-DTC(differentiated thyroid cancer)patients ③ Non-cn0(Clinically N0) patients ④ cN0(Clinically N0) patients but could not be operated on.
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 |
|---|---|---|
| contralateral central lymph node dissectioncontralateral central lymph node dissection | Procedure or surgery | Tumor diameter<=2cm study group, Tumor diameter>2cm study group |
Primary outcome
Tumor diameter
Time frame: 12 months
Tumor diameter will be measured by postoperative pathological examination.
Number of lymph nodes dissected in every side of central lymph node
Time frame: 12 months
Count the number of lymph nodes dissected during operation in every side of central lymph nodes of every Participants.
Number of metastatic lymph nodes diagnosed by Postoperative pathology
Time frame: 12 months
Count the number of metastatic lymph nodes diagnosed by Postoperative pathology in every side of central lymph nodes of every Participants.
1 secondary outcome
Rate of lymph nodes metastasis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contralateral central lymph node dissection in people with Lymph Node Dissection and Lymph Node Metastases, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site 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 6 inclusion and 6 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Qingan Zeng, doctor (0756-2528810, zengqa1218@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor diameter (time frame: 12 months). 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 24 Nov 2020.