Papillary Thyroid CarcinomaNCT04197960
Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma
A study testing Microwave ablation and Surgical resection in people with Papillary Thyroid Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The study aimed to compare the efficacy and safety of papillary thyroid microcarcinoma (PTMC) treated with microwave ablation(MWA) and surgery resection (SR), and to explore the tumor characteristics suitable for each treatment methods (such as with and without capsular invasion). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Papillary Thyroid Carcinoma
- What is being tested?
- Microwave ablation and Surgical resection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 973 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Dec 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biopsy pathology proved micropapillary thyroid carcinoma(mPTC), but not high-risk subtype
- Solitary mPTC, without US-detected gross extrathyroid extension
- No evidence of metastasis
- Willing to participate in this study and perform regular follow-up
Who cannot join
- Severe blood coagulation dysfunction (platelet count < 50x109/L cells or INR>1.5)
- Acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
- Poor control of blood pressure(systolic pressure≥150mmHg or diastolic pressure≥95mmHg)
- Poor control of blood glucose(fasting glucose>10mmol/L)
- The opposite vocal cords dysfunction
- Diagnosed with other malignant tumors
- Pregnant and lactating women
- Other conditions that investigator believe are not appropriate to be enrolled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Study to Compare the Therapeutic Outcomes of Microwave Ablation With Surgical Resection for Micropapillary Thyroid Carcinoma
The study aimed to compare the efficacy and safety of papillary thyroid microcarcinoma (PTMC) treated with microwave ablation(MWA) and surgery resection (SR), and to explore the tumor characteristics suitable for each treatment methods (such as with and without capsular invasion). The investigators organized 18 hospitals to participate in this multicenter study. Patients meeting following indications will be included in this study: 1. Biopsy pathology proved PTMC, but not high-risk subtype; 2. solitary mPTC, without US-detected gross extrathyroid extension; 3. no evidence of metastasis; 4 willing to participate in this study and perform regular follow-up. Patients themselves decide to receive MWA or SR for mPTC after medical consultation. Baseline characteristic including age, gender, thyroid function et al. will be collected. The treatment protocols of MWA and SR were according to the Chinese and international guidelines. The primary outcomes were the disease progression, including local tumor recurrence, lymph node metastasis, and distant metastasis. The secondary outcomes include thyroid function, complication rate, blood loss et al. Investigators will follow up enrolled patients and collect and upload data according to the trial. Treatment outcomes of tumor with and without US-detected capsular invasion was analyzes as subgroups.
Read the detailed description
The treatment protocols of MWA and SR were according to the Chinese and international guidelines. MWA need to ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule. SR basic protocol is lobectomy. All patients need to receive levothyroxine therapy to keep TSH lower than 0.5 mU/L. Patients in both groups underwent regular medical imaging and laboratory tests 1 month, 3-month, 6-month, 12-month, 18-month, 24-month and 36-month after treatment.
- Conditions
- Papillary Thyroid Carcinoma
- Being tested
- Microwave ablation, Surgical resection
- Keywords
- Papillary Thyroid Carcinoma, Microwave ablation, Surgical resection
- 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.
Microwave ablationProcedure or surgery
Use thermal energy to destroy tumor
Surgical resectionProcedure or surgery
Resect tumors
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation | Experimental | ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule. Receives: Procedure: Microwave ablation |
| surgical resection | Active comparator | thyroid lobectomy, total thyroidectomy, central lymph node dissection Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
local tumor progression
the number of patients with tumor progression around the treated area
Measured: 2-year
lymph node metastasis
the number of patients with lymph node metastasis
Measured: 2-year
distant metastasis
the number of patients with thyroid cancer metastasizing to distant tissues or organs
Measured: 2-year
New thyroid cancer
the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland
Measured: 2-year
Disease progression
the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.
Measured: 2-year
Secondary outcomes (5)
complication rate
complication rate encouned during or after procedures
Measured: 2-year
blood loss
the volume of blood loss during procedures
Measured: 2-year
free thyroxine
change of free thyroxine concentration
Measured: 2-year
free triiodothyronine
change of free triiodothyronine concentration
Measured: 2-year
thyroid-stimulating hormone
change of thyroid-stimulating hormone concentration
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- None (open label)
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197960
- Sponsor's protocol ID
- 301jrcsk-lp
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2019
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng L, Du QW, Dou JP, Liu FY, Yu J, Cheng ZG, Yu XL, Tan SL, Wang H, Cong ZB, Wang SR, Yu MA, Xu ZF, Che Y, Bai N, Liu C, Huo SN, Hao Y, Wang X, Liu Y, Zhou Y, Han ZY, Liang P. Microwave ablation for T1N0M0 papillary thyroid carcinoma located in the isthmus: a multicenter prospective cohort study with over 5-year follow-up. Ther Adv Med Oncol. 2026 Apr 24;18:17588359261442628. doi: 10.1177/17588359261442628. eCollection 2026.
PubMed 42064641Dou J, Zheng L, Han Z, Che Y, Wang S, Cong Z, Hao Y, Zhou Y, Huo S, Liang P. Microwave Ablation Versus Thyroid Lobectomy for Solitary cT1aN0M0 Papillary Thyroid Carcinoma: A Prospective Multicenter Cohort Study. Mayo Clin Proc Innov Qual Outcomes. 2026 Feb 27;10(2):100696. doi: 10.1016/j.mayocpiqo.2026.100696. eCollection 2026 Apr.
PubMed 41800228Zheng L, Dou JP, Han ZY, Liu FY, Yu J, Cheng ZG, Yu XL, Wang H, Cong ZB, Wang SR, Yu MA, Xu ZF, Che Y, Nan B, Liu C, Hao Y, Wang X, Liu Y, Zhou Y, Liang P. Microwave Ablation for Papillary Thyroid Microcarcinoma with and without US-detected Capsule Invasion: A Multicenter Prospective Cohort Study. Radiology. 2023 May;307(3):e220661. doi: 10.1148/radiol.220661. Epub 2023 Mar 7.
PubMed 36880949
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study to Compare the Therapeutic Outcomes of Microwave Ablation With Surgical Resection for Micropapillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT04197960
- Acronym / sponsor ID
- 301jrcsk-lp
- Conditions
- Papillary Thyroid Carcinoma
- Keywords
- Papillary Thyroid Carcinoma, Microwave ablation, Surgical resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Dec 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.
The study aimed to compare the efficacy and safety of papillary thyroid microcarcinoma (PTMC) treated with microwave ablation(MWA) and surgery resection (SR), and to explore the tumor characteristics suitable for each treatment methods (such as with and without capsular invasion). The investigators organized 18 hospitals to participate in this multicenter study. Patients meeting following indications will be included in this study: 1. Biopsy pathology proved PTMC, but not high-risk subtype; 2. solitary mPTC, without US-detected gross extrathyroid extension; 3. no evidence of metastasis; 4 willing to participate in this study and perform regular follow-up. Patients themselves decide to receive MWA or SR for mPTC after medical consultation. Baseline characteristic including age, gender, thyroid function et al. will be collected. The treatment protocols of MWA and SR were according to the Chinese and international guidelines. The primary outcomes were the disease progression, including local tumor recurrence, lymph node metastasis, and distant metastasis. The secondary outcomes include thyroid function, complication rate, blood loss et al. Investigators will follow up enrolled patients and collect and upload data according to the trial. Treatment outcomes of tumor with and without US-detected capsular invasion was analyzes as subgroups.
Detailed description
The treatment protocols of MWA and SR were according to the Chinese and international guidelines. MWA need to ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule. SR basic protocol is lobectomy. All patients need to receive levothyroxine therapy to keep TSH lower than 0.5 mU/L. Patients in both groups underwent regular medical imaging and laboratory tests 1 month, 3-month, 6-month, 12-month, 18-month, 24-month and 36-month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microwave ablation | Experimental | Procedure: Microwave ablationablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule. |
| surgical resection | Active comparator | Procedure: Surgical resectionthyroid lobectomy, total thyroidectomy, central lymph node dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy pathology proved micropapillary thyroid carcinoma(mPTC), but not high-risk subtype
- Solitary mPTC, without US-detected gross extrathyroid extension
- No evidence of metastasis
- Willing to participate in this study and perform regular follow-up
Key exclusion criteria (8 listed)
- Severe blood coagulation dysfunction (platelet count < 50x109/L cells or INR>1.5)
- Acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
- Poor control of blood pressure(systolic pressure≥150mmHg or diastolic pressure≥95mmHg)
- Poor control of blood glucose(fasting glucose>10mmol/L)
- The opposite vocal cords dysfunction
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 |
|---|---|---|
| Microwave ablationUse thermal energy to destroy tumor | Procedure or surgery | microwave ablation |
| Surgical resectionResect tumors | Procedure or surgery | surgical resection |
Primary outcome
local tumor progression
Time frame: 2-year
the number of patients with tumor progression around the treated area
lymph node metastasis
Time frame: 2-year
the number of patients with lymph node metastasis
distant metastasis
Time frame: 2-year
the number of patients with thyroid cancer metastasizing to distant tissues or organs
New thyroid cancer
Time frame: 2-year
the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland
Disease progression
Time frame: 2-year
the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.
5 secondary outcomes
complication rate
Time frame: 2-year
blood loss
Time frame: 2-year
free thyroxine
Time frame: 2-year
free triiodothyronine
Time frame: 2-year
thyroid-stimulating hormone
Time frame: 2-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 42064641Zheng L, Du QW, Dou JP, Liu FY, Yu J, Cheng ZG, Yu XL, Tan SL, Wang H, Cong ZB, Wang SR, Yu MA, Xu ZF, Che Y, Bai N, Liu C, Huo SN, Hao Y, Wang X, Liu Y, Zhou Y, Han ZY, Liang P. Microwave ablation for T1N0M0 papillary thyroid carcinoma located in the isthmus: a multicenter prospective cohort study with over 5-year follow-up. Ther Adv Med Oncol. 2026 Apr 24;18:17588359261442628. doi: 10.1177/17588359261442628. eCollection 2026.
- Derived from this study: PubMed 41800228Dou J, Zheng L, Han Z, Che Y, Wang S, Cong Z, Hao Y, Zhou Y, Huo S, Liang P. Microwave Ablation Versus Thyroid Lobectomy for Solitary cT1aN0M0 Papillary Thyroid Carcinoma: A Prospective Multicenter Cohort Study. Mayo Clin Proc Innov Qual Outcomes. 2026 Feb 27;10(2):100696. doi: 10.1016/j.mayocpiqo.2026.100696. eCollection 2026 Apr.
- Derived from this study: PubMed 36880949Zheng L, Dou JP, Han ZY, Liu FY, Yu J, Cheng ZG, Yu XL, Wang H, Cong ZB, Wang SR, Yu MA, Xu ZF, Che Y, Nan B, Liu C, Hao Y, Wang X, Liu Y, Zhou Y, Liang P. Microwave Ablation for Papillary Thyroid Microcarcinoma with and without US-detected Capsule Invasion: A Multicenter Prospective Cohort Study. Radiology. 2023 May;307(3):e220661. doi: 10.1148/radiol.220661. Epub 2023 Mar 7.
- 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.
Ping Liang principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation and Surgical resection in people with Papillary Thyroid Carcinoma, run by Chinese PLA General Hospital 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 4 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: finished, as of the sponsor's last update on 5 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local tumor progression (time frame: 2-year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197960, which also lists 3 linked publications.
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 5 Aug 2025.