Papillary Thyroid CancerPhase 3NCT06791005
A Clinical Study on the Benefits of Carbon Nanoparticles Injection Time in Patients With Thyroid Cancer.
A Phase 3 study testing Preoperative Injection of Carbon Nanoparticles and Intraoperative Injection of Carbon Nanoparticles in people with Papillary Thyroid Cancer, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
The detection rate of thyroid cancer (PTC) has increased rapidly in recent years. Except undifferentiated cancer, surgery is still one of the most important treatments for all types of thyroid cancer, and there is a consensus to use the lobes of the gland as the minimum extent of resection. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- Preoperative Injection of Carbon Nanoparticles and Intraoperative Injection of Carbon Nanoparticles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preoperative pathological assessment indicated the presence of thyroid cancer with a maximum diameter of less than 4 cm.
- Postoperative pathological evaluation confirmed bilateral thyroid cancer or lateral lymph node metastasis.
- Vocal cord examination conducted one week prior to surgery revealed no abnormalities.
- The patient had no history of prior thyroid surgery and required a total thyroidectomy.
- Blood pressure was stably controlled.
- The patient regained consciousness and was able to communicate normally.
Who cannot join
- Prior to enrollment, the patient had received radiotherapy, chemotherapy, or isotope therapy.
- A documented history of thyroid surgery.
- Age under 16 years.
- Known allergies to the medications under investigation or an inability to tolerate surgical intervention.
- Presence of a retrosternal thyroid tumor.
- Tumor invasion of the parathyroid glands and/or the recurrent laryngeal nerve during surgical procedures.
- Postoperative pathology suggestive of medullary carcinoma or undifferentiated carcinoma.
- Development of a postoperative tracheal fistula.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Yang Liu, doctor, 0086+029-13384986500, individualliu@163.com
About this study
Official title: A Comparative Study of Preoperative and Intraoperative Carbon Nanoparticles Injection in Patients Undergoing Thyroid Cancer Surgery
The detection rate of thyroid cancer (PTC) has increased rapidly in recent years. Except undifferentiated cancer, surgery is still one of the most important treatments for all types of thyroid cancer, and there is a consensus to use the lobes of the gland as the minimum extent of resection. In the meantime, a basic consensus has been reached that central zone lymph node (VI) dissection is the minimum extent of lymph node dissection. In clinical practice, neck surgery and lumpectomy are mostly performed. Hypoparathyroidism and recurrent laryngeal nerve injury are the most common complications of radical surgery for thyroid cancer, both in open surgery and the luminal approach. Once these complications occur, they have a serious impact on the quality of life of patients in the postoperative period. A number of contrast agents are now being used to help minimize complications. Carbon nanoparticles are an effective and non-harmful negative developer, and many studies have confirmed that carbon nanoparticles can be used to identify parathyroid glands in thyroid surgery. Intraoperative injection of nanocarbon is effective in increasing the quality of intraoperative parathyroid detection and lymph node clearance and reducing adverse effects, such as postoperative hypokalemia.However, there is no complete clinical guideline for preoperative intraglandular injection of carbon nanoparticles, and there is no standardized dosage for appropriate injection time, injection dose, and injection method. At the same time, there is still the problem of carbon nanoparticle leakage. At our medical center, we have found that preoperative injection of carbon nanoparticles via ultrasound-guided fine needle puncture may yield better results by reducing CNS exudation in the surgical area. In this study, we will collect more than 400 patients who underwent thyroidectomy in 2025 and underwent carbon nanoparticle injections at different time points and analyzed their intraoperative and postoperative conditions as a basis for analyzing the difference in patient benefits between preoperative and intraoperative carbon nanoparticle injections and to provide data to support the clinical use of carbon nanoparticles.
Read the detailed description
- Use of drugs: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland.
- Conditions
- Papillary Thyroid Cancer
- Being tested
- Preoperative Injection of Carbon Nanoparticles, Intraoperative Injection of Carbon Nanoparticles
- Keywords
- Papillary Thyroid Cancer, thyroid surgery, developer, complication
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Injection of Carbon NanoparticlesDrug
1.Medication: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. 2.Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland.
Intraoperative Injection of Carbon NanoparticlesDrug
Intraoperative injection of carbon nanoparticles: After exposing the thyroid peritoneum, 0.1 mL of carbon nanoparticles was injected into both sides of normal thyroid tissue using a syringe (1 mL). Two spots were needed for each flap, and the total volume of injected carbon nanoparticles was 0.4 mL. Finally, the needle was gently backed up under negative pressure to prevent the leakage of carbon nanoparticles.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Injection Before Partial Thyroidectomy Group | Experimental | Patients in this group will undergo partial thyroidectomy and preoperative injection of carbon nanoparticles. Receives: Drug: Preoperative Injection of Carbon Nanoparticles |
| Intraoperative Injection During Partial Thyroidectomy Group | Active comparator | Patients in this group will undergo partial thyroidectomy and intraoperative injection of carbon nanoparticles. Receives: Drug: Intraoperative Injection of Carbon Nanoparticles |
| Preoperative Injection Before Total Thyroidectomy Group | Experimental | Patients in this group will undergo total thyroidectomy and preoperative injection of carbon nanoparticles. Receives: Drug: Preoperative Injection of Carbon Nanoparticles |
| Intraoperative Injection During Total Thyroidectomy Group | Active comparator | Patients in this group will undergo total thyroidectomy and intraoperative injection of carbon nanoparticles. Receives: Drug: Intraoperative Injection of Carbon Nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
age
Age will be aggregated using "years" as the unit of measurement.
Measured: up to three years
Genders
Data will be summarized in terms of "male" and "female" as units of measurement.
Measured: up to three years
Height
The height indicator will summarize the data in "meters".
Measured: up to three years
Weight
The weight indicator will summarize data in "kilograms".
Measured: up to three years
BMI
BMI will be summarized in "kg/m^2".
Measured: up to three years
Tumor Diameter Size
Tumor diameter size will be summarized in "millimeters".
Measured: up to three years
Tumor Location
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multifocal" as units of measurement.
Measured: up to three years
Pathological Results
Data will be summarized in terms of detailed pathological results and "none" .
Measured: up to three years
Preoperative Serum Calcium
The Calcium indicator will summarize data in "mmol/L".
Measured: up to three years
Preoperative Serum Thyroid Hormone
The thyroid hormone indicator will summarize data in "pmol/L".
Measured: up to three years
Preoperative Serum Parathyroid Hormone
The parathyroid hormone will summarize data in "pmol/L".
Measured: up to three years
Preoperative serum TSH
The TSH indicator will summarize data in "mlU/L".
Measured: up to three years
Preoperative Vocal Cord Movement Problems or Laryngoscopy Result
Data will be summarized in terms of "normal" , "symptomatic" and "laryngoscopy abnormal" as units of measurement.
Measured: up to three years
Carbon Nanoparticles Injection Site
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multi-site injection" as units of measurement.
Measured: up to three years
Number of Carbon Nanoparticles Injections
Number of Carbon Nanoparticles Injections
Measured: up to three years
Carbon Nanoparticles Injection Dose
Injection dose will be summarized in "milliliter".
Measured: up to three years
Duration of The Operation
The duration of the operation will summarize data in "h". The time interval from the induction of anesthesia to the end of surgery was selected as the length of surgery, according to the surgical care records
Measured: up to three years
Number of Lymph Node Dissection
Record the total number of lymph nodes dissected, the number of lymph nodes dissected in the central region, the number of lymph nodes dissected in the lateral cervical region and the number of metastatic lymph nodes detected.
Measured: up to three years
Intraoperative Hemorrhage
The intraoperative hemorrhage will summarize data in "milliliter".
Measured: up to three years
Thyroid Staining
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The stained thyroid is good in the center and at the margins, with clear staining at the edges; B.The stained thyroid gland has good central staining, and the margins are grossly stained, so that the marginal pattern can be roughly observed; C.The stained thyroid stains well, with poorly stained margins;
Measured: up to three years
Lymph node staining
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The center and margins of the stained lymph nodes are well stained, and the margins are clearly stained; B. The stained lymph nodes have good central staining and grossly stained margins; the marginal pattern can be roughly observed, and the lymph nodes are definite on palpation; C.Good central staining of the stained lymph nodes, unclear staining of the margins, and precise palpation of the lymph nodes.
Measured: up to three years
Parathyroid Glands Staining
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.Good central infiltration, uniform and clear staining throughout the gland; B.Central infiltration is good, staining of the entire gland is still uniform, but flaky stained areas are seen, and the gland is exact on palpation; C.Central infiltration is fair, staining of the entire gland is stellate with no obvious shape, and the gland is exact on palpation.
Measured: up to three years
Nanocarbon Leakage
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.no visible leakage, only slight leakage at the injection site, not affecting the parathyroid glands or the recurrent laryngeal nerve; B.leakage is present and visible to the naked eye, but less than 1/2 of the entire operative field, with staining of the trachea, thyroid peritoneum, and anterior cervical musculature; C.Leakage is present and reaches 1/2 of the entire operative field or Carbon Nanoparticles results in staining of the parathyroid glands or the recurrent laryngeal nerve, affecting identification.
Measured: up to three years
Duration of Postoperative Pain
The duration of postoperative pain will summarize data in "days".
Measured: up to three years
Postoperative Drainage
The postoperative drainage will summarize data in "milliliter".
Measured: up to three years
Length of Postoperative Hospitalization
The length of postoperative hospitalization will summarize data in "days"
Measured: up to three years
Postoperative Serum Parathyroid Hormone
The parathyroid hormone will summarize data in "pmol/L".
Measured: up to three years
Numbness of The Hands and Feet
The numbness of the hands and feet will be summarized with a "yes" or "no" to the data.
Measured: up to three years
Postoperative Laryngeal Recurrent Nerve Irritation and Injury
Postoperative laryngeal recurrent nerve irritation and injury will be summarized with a "yes" or "no" to the data.
Measured: up to three years
Postoperative Hematoma
The postoperative hematoma will be summarized with a "yes" or "no" to the data.
Measured: up to three years
Postoperative Tracheocutaneous Fistula
The postoperative tracheocutaneous fistula will be summarized with a "yes" or "no" to the data.
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791005
- Sponsor's protocol ID
- nanoc
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Preoperative and Intraoperative Carbon Nanoparticles Injection in Patients Undergoing Thyroid Cancer Surgery
- ClinicalTrials.gov ID
- NCT06791005
- Acronym / sponsor ID
- nanoc
- Conditions
- Papillary Thyroid Cancer
- Keywords
- Papillary Thyroid Cancer, thyroid surgery, developer, complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
The detection rate of thyroid cancer (PTC) has increased rapidly in recent years. Except undifferentiated cancer, surgery is still one of the most important treatments for all types of thyroid cancer, and there is a consensus to use the lobes of the gland as the minimum extent of resection. In the meantime, a basic consensus has been reached that central zone lymph node (VI) dissection is the minimum extent of lymph node dissection. In clinical practice, neck surgery and lumpectomy are mostly performed. Hypoparathyroidism and recurrent laryngeal nerve injury are the most common complications of radical surgery for thyroid cancer, both in open surgery and the luminal approach. Once these complications occur, they have a serious impact on the quality of life of patients in the postoperative period. A number of contrast agents are now being used to help minimize complications. Carbon nanoparticles are an effective and non-harmful negative developer, and many studies have confirmed that carbon nanoparticles can be used to identify parathyroid glands in thyroid surgery. Intraoperative injection of nanocarbon is effective in increasing the quality of intraoperative parathyroid detection and lymph node clearance and reducing adverse effects, such as postoperative hypokalemia.However, there is no complete clinical guideline for preoperative intraglandular injection of carbon nanoparticles, and there is no standardized dosage for appropriate injection time, injection dose, and injection method. At the same time, there is still the problem of carbon nanoparticle leakage. At our medical center, we have found that preoperative injection of carbon nanoparticles via ultrasound-guided fine needle puncture may yield better results by reducing CNS exudation in the surgical area. In this study, we will collect more than 400 patients who underwent thyroidectomy in 2025 and underwent carbon nanoparticle injections at different time points and analyzed their intraoperative and postoperative conditions as a basis for analyzing the difference in patient benefits between preoperative and intraoperative carbon nanoparticle injections and to provide data to support the clinical use of carbon nanoparticles.
Detailed description
- Use of drugs: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preoperative Injection Before Partial Thyroidectomy Group | Experimental | Drug: Preoperative Injection of Carbon NanoparticlesPatients in this group will undergo partial thyroidectomy and preoperative injection of carbon nanoparticles. |
| Intraoperative Injection During Partial Thyroidectomy Group | Active comparator | Drug: Intraoperative Injection of Carbon NanoparticlesPatients in this group will undergo partial thyroidectomy and intraoperative injection of carbon nanoparticles. |
| Preoperative Injection Before Total Thyroidectomy Group | Experimental | Drug: Preoperative Injection of Carbon NanoparticlesPatients in this group will undergo total thyroidectomy and preoperative injection of carbon nanoparticles. |
| Intraoperative Injection During Total Thyroidectomy Group | Active comparator | Drug: Intraoperative Injection of Carbon NanoparticlesPatients in this group will undergo total thyroidectomy and intraoperative injection of carbon nanoparticles. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Preoperative pathological assessment indicated the presence of thyroid cancer with a maximum diameter of less than 4 cm.
- Postoperative pathological evaluation confirmed bilateral thyroid cancer or lateral lymph node metastasis.
- Vocal cord examination conducted one week prior to surgery revealed no abnormalities.
- The patient had no history of prior thyroid surgery and required a total thyroidectomy.
- Blood pressure was stably controlled.
Key exclusion criteria (8 listed)
- Prior to enrollment, the patient had received radiotherapy, chemotherapy, or isotope therapy.
- A documented history of thyroid surgery.
- Age under 16 years.
- Known allergies to the medications under investigation or an inability to tolerate surgical intervention.
- Presence of a retrosternal thyroid tumor.
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 |
|---|---|---|
| Preoperative Injection of Carbon Nanoparticles1.Medication: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. 2.Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland. | Drug | Preoperative Injection Before Partial Thyroidectomy Group, Preoperative Injection Before Total Thyroidectomy Group |
| Intraoperative Injection of Carbon NanoparticlesIntraoperative injection of carbon nanoparticles: After exposing the thyroid peritoneum, 0.1 mL of carbon nanoparticles was injected into both sides of normal thyroid tissue using a syringe (1 mL). Two spots were needed for each flap, and the total volume of injected carbon nanoparticles was 0.4 mL. Finally, the needle was gently backed up under negative pressure to prevent the leakage of carbon nanoparticles. | Drug | Intraoperative Injection During Partial Thyroidectomy Group, Intraoperative Injection During Total Thyroidectomy Group |
Primary outcome
age
Time frame: up to three years
Age will be aggregated using "years" as the unit of measurement.
Genders
Time frame: up to three years
Data will be summarized in terms of "male" and "female" as units of measurement.
Height
Time frame: up to three years
The height indicator will summarize the data in "meters".
Weight
Time frame: up to three years
The weight indicator will summarize data in "kilograms".
BMI
Time frame: up to three years
BMI will be summarized in "kg/m^2".
Tumor Diameter Size
Time frame: up to three years
Tumor diameter size will be summarized in "millimeters".
Tumor Location
Time frame: up to three years
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multifocal" as units of measurement.
Pathological Results
Time frame: up to three years
Data will be summarized in terms of detailed pathological results and "none" .
Preoperative Serum Calcium
Time frame: up to three years
The Calcium indicator will summarize data in "mmol/L".
Preoperative Serum Thyroid Hormone
Time frame: up to three years
The thyroid hormone indicator will summarize data in "pmol/L".
Preoperative Serum Parathyroid Hormone
Time frame: up to three years
The parathyroid hormone will summarize data in "pmol/L".
Preoperative serum TSH
Time frame: up to three years
The TSH indicator will summarize data in "mlU/L".
Preoperative Vocal Cord Movement Problems or Laryngoscopy Result
Time frame: up to three years
Data will be summarized in terms of "normal" , "symptomatic" and "laryngoscopy abnormal" as units of measurement.
Carbon Nanoparticles Injection Site
Time frame: up to three years
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multi-site injection" as units of measurement.
Number of Carbon Nanoparticles Injections
Time frame: up to three years
Number of Carbon Nanoparticles Injections
Carbon Nanoparticles Injection Dose
Time frame: up to three years
Injection dose will be summarized in "milliliter".
Duration of The Operation
Time frame: up to three years
The duration of the operation will summarize data in "h". The time interval from the induction of anesthesia to the end of surgery was selected as the length of surgery, according to the surgical care records
Number of Lymph Node Dissection
Time frame: up to three years
Record the total number of lymph nodes dissected, the number of lymph nodes dissected in the central region, the number of lymph nodes dissected in the lateral cervical region and the number of metastatic lymph nodes detected.
Intraoperative Hemorrhage
Time frame: up to three years
The intraoperative hemorrhage will summarize data in "milliliter".
Thyroid Staining
Time frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The stained thyroid is good in the center and at the margins, with clear staining at the edges; B.The stained thyroid gland has good central staining, and the margins are grossly stained, so that the marginal pattern can be roughly observed; C.The stained thyroid stains well, with poorly stained margins;
Lymph node staining
Time frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The center and margins of the stained lymph nodes are well stained, and the margins are clearly stained; B. The stained lymph nodes have good central staining and grossly stained margins; the marginal pattern can be roughly observed, and the lymph nodes are definite on palpation; C.Good central staining of the stained lymph nodes, unclear staining of the margins, and precise palpation of the lymph nodes.
Parathyroid Glands Staining
Time frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.Good central infiltration, uniform and clear staining throughout the gland; B.Central infiltration is good, staining of the entire gland is still uniform, but flaky stained areas are seen, and the gland is exact on palpation; C.Central infiltration is fair, staining of the entire gland is stellate with no obvious shape, and the gland is exact on palpation.
Nanocarbon Leakage
Time frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.no visible leakage, only slight leakage at the injection site, not affecting the parathyroid glands or the recurrent laryngeal nerve; B.leakage is present and visible to the naked eye, but less than 1/2 of the entire operative field, with staining of the trachea, thyroid peritoneum, and anterior cervical musculature; C.Leakage is present and reaches 1/2 of the entire operative field or Carbon Nanoparticles results in staining of the parathyroid glands or the recurrent laryngeal nerve, affecting identification.
Duration of Postoperative Pain
Time frame: up to three years
The duration of postoperative pain will summarize data in "days".
Postoperative Drainage
Time frame: up to three years
The postoperative drainage will summarize data in "milliliter".
Length of Postoperative Hospitalization
Time frame: up to three years
The length of postoperative hospitalization will summarize data in "days"
Postoperative Serum Parathyroid Hormone
Time frame: up to three years
The parathyroid hormone will summarize data in "pmol/L".
Numbness of The Hands and Feet
Time frame: up to three years
The numbness of the hands and feet will be summarized with a "yes" or "no" to the data.
Postoperative Laryngeal Recurrent Nerve Irritation and Injury
Time frame: up to three years
Postoperative laryngeal recurrent nerve irritation and injury will be summarized with a "yes" or "no" to the data.
Postoperative Hematoma
Time frame: up to three years
The postoperative hematoma will be summarized with a "yes" or "no" to the data.
Postoperative Tracheocutaneous Fistula
Time frame: up to three years
The postoperative tracheocutaneous fistula will be summarized with a "yes" or "no" to the data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preoperative Injection of Carbon Nanoparticles and Intraoperative Injection of Carbon Nanoparticles in people with Papillary Thyroid Cancer, run by Second Affiliated Hospital of Xi'an Jiaotong 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 8 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu, doctor (0086+029-13384986500, individualliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: up to three years). The study lists 31 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 Jan 2025.