Thyroid CancerNCT03377829
A Multicenter Trial of PLA vs. Surgery for Treating PTMC
A study testing PLA and Thyroid Surgery in people with Thyroid Cancer and Treatment Related Cancer, run by WeiWei Zhan at 13 sites in 2 countries.
Trial summary
This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Treatment Related Cancer
- What is being tested?
- PLA and Thyroid Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Dec 2017to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed PTMC (maximun diameter> = 5 mm and < = 10 mm) proved by fine needle aspiration biopsy with good thyroid function;
- Age≥ 18 Y;
- Single nodule without thyroid capsule contact;
- There had more than 3mm distance between nodules and trachea, carotid artery, recurrent laryngeal nerve (The distance should up to 5mm after injection of isolation fluid);
- No coarse calcification or eggshell-like calcification;
- Imaging examination without local or distant metastasis;
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- Without chemotherapy, radiotherapy and other related therapies;
- A complete clinical, pathological and follow-up information;
- Get informed consent signed by the patient or family member.
Who cannot join
- Multifocal PTMC;
- Combined with other types of thyroid cancer or hyperthyroidism;
- Lesion contact with thyroid capsule or located in the isthmus;
- Serious coagulation dysfunction;
- Contralateral vocal cord paralysis;
- Imaging examination with local or distant metastasis;
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- Active Tuberculosis and HIV-positive patients;
- Patients can not understand or follow research protocol;
- Pregnant woman.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
China11 sites, 11 recruiting
- Recruiting
Ultrasound Department, Chinese PLA General Hospital
Beijing, Beijing Municipality, 010
Ming-bo Zhang, +8613552744805, owsifanduizhe@126.com
Fang Xie, +8613717981887, lmsh1225@163.com
- Recruiting
Ultrasound Department, the Xiangya Third Hospital of Zhongnan University
Changsha, Hunan, 731
Wen-gang Liu, +8615116342563, 593987695@qq.com
Ping Zhou, +8613974809881, zhouping1000@hotmail.com
- Recruiting
Ultrasound Department of the Third Hospital Affiliated to Zhongshan University
Guangzhou, Guangdong, 020
Tao Wu, +8613560332786, wutao83@126.com
Jie Ren, +8613925155583, 13925155583@126.com
- Recruiting
Department of Ultrasonography, Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 571
Dong Xu, +86057188122255, xudong@zjcc.org.cn
Li-ping Wang, +85057188122252, wanglp@zjcc.org.cn
- Recruiting
Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University
Hangzhou, Zhejiang, 571
Qi-yu Zhao, +8613819140217, derman2000@126.com
- Recruiting
Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity
Harbin, Heilongjiang, 451
Shuang-quan Jiang, +8613704800486, 23237003@qq.com
Guo-qing Du, +8615945164997
- Recruiting
Ultrasound Department, the First Affliction Hospital of Nanjing Medical University
Nanjing, Jiangsu, 025
Hong-yan Deng, +8618262637897, 603655097@qq.com
Jing Hang, +8613951827096, hangjing411714@163.com
- Recruiting
Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 021
Qiu-sheng Shi, +8613311986321, sqs19631989@163.com
Lian-fang Du, +8613386259562, Du_lf@163.com
- Recruiting
Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 021
Lu Zhang, +8615021590551, aluer2013@163.com
Wei Zhou, +8613681642667, zw11468@126.com
- Recruiting
Ultrasound Department, the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 557
Xiao-feng Wu, +8618510516168, xiaofengwu0115@163.com
Feng-lin Dong, +8613771978973, 13771978973@163.com
- Recruiting
The department of ultrasound ,second affiliated hospital of xi'an jiaotong university
Xi’an, Shanxi, 029
Wan-ying Jia, +8615529619387, jia331@126.com
Jue Jiang, +8618066736699, 13720721677@163.com
Italy2 sites, 2 recruiting
- Recruiting
Department of Endocrinology, Regina Apostolorum Hospital
Rome
Enrico Papini, papinie@gmail.com
- Recruiting
Diagnostic Imaging, Regina Apostolorum Hospital
Rome
Giancarlo Bizzarri, bizzarrigiancarlo@libero.it
About this study
Official title: A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma
This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).
Read the detailed description
PLA is the acronym for "Percutaneous Laser Ablation". The treatment consists in the destruction (ablation) of Papillary Thyroid Micro Carcinoma by means of optical fibers that deliver high-energy light (laser) into the lesion through skin puncturing (percutaneous). The procedure is performed under ultrasound imaging guidance (ultrasound-guided). The destruction of the lesion occurs through overheating and coagulation. PLA, however, still needs a large-scale validation trial in order to be considered as an effective alternative to both surgery or follow-up for low-risk PTMC in elderly patients and/or in patients with co-morbidities that might expose the patients to a high surgical risk.
After a comprehensive information, patients will be consecutively assigned to Group 1 (surgery, preferentially lobectomy) or to Group 2 (percutaneous laser ablation, performed according to the attached procedure).Peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered.
The aims of this study are as follows: 1.To establish the rate of cure or partial ablation; 2.To compare the complication rate, time expenditure and costs of two procedures; 3.To assess changes in thyroid function and the need of substitution therapy with two procedures; 4.To assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and PLA.
- Conditions
- Thyroid Cancer, Treatment Related Cancer
- Being tested
- PLA, Thyroid Surgery
- Keywords
- Papillary Thyroid Microcarcinoma, Percutaneous Laser Ablation, thyroidectomy, ultrasonography, double-blind
- Medical subject headings
- Thyroid Neoplasms, Neoplasms, Second Primary, Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAProcedure or surgery
During the PLA, the patient is in supine position with head extended: the physician, ultrasound assistant and trained nurse work within the sterile field. Under constant ultrasound image guidance and after local anesthesia by means of 2% xylocaine infiltration, thin needles (21G) are positioned in the thyroid lesion, within safety distance from the surrounding anatomical structures. A plane-cut tip fiber optics is inserted into the PTMC through the needle. The laser at 1064 nm wavelength is turned on for 10 minutes until the pre-established energy dose is attained. There is usually no pain or very limited pain.
Thyroid SurgeryProcedure or surgery
Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat, placenta muscle are incised successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process. Finally patient is performed total thyroidectomy or subtotal thyroidectomy.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous laser ablation(PLA) | Experimental | Eligible participants with PTMC will be randomly assigned to this group and undergo percutaneous laser ablation(PLA). All the process is under the detection of real-time ultrasound.After surgery, all the patients will accept contrast-enhanced ultrasound(CEUS), regular ultrasound follow-up, thyroid functional detection, fine-needle aspiration biopsy(FNAB), neck CT.Per and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered. Receives: Procedure: PLA |
| Surgery | Active comparator | Eligible participants with PTMC will be randomly assigned to this group and undergo total/subtotal thyroid surgery. Receives: Procedure: Thyroid Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological examination of thyroid function
Hyperthyreosis or hypothyroidism.
Measured: up to 12 months
Secondary outcomes (2)
Recurrence rate
The recurrence rate in the thyroid bed or regional lymph-nodes
Measured: up to 12 months
Therapeutic Effect
The rate of cure (defined as the absence of disease persistence at US examination and FNAB) between two methods.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Dec 2017
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WeiWei Zhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, WeiWei Zhan, Ruijin Hospital
- Investigators
- WeiWei Zhan, Ph.D, Principal investigator, Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377829
- Sponsor's protocol ID
- 1001253709008902933
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2017
- Last updated
- 19 Mar 2021
- 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 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma
- ClinicalTrials.gov ID
- NCT03377829
- Acronym / sponsor ID
- 1001253709008902933
- Conditions
- Thyroid Cancer, Treatment Related Cancer
- Keywords
- Papillary Thyroid Microcarcinoma, Percutaneous Laser Ablation, thyroidectomy, ultrasonography, double-blind
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- WeiWei ZhanUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Dec 2017 (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.
This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).
Detailed description
PLA is the acronym for "Percutaneous Laser Ablation". The treatment consists in the destruction (ablation) of Papillary Thyroid Micro Carcinoma by means of optical fibers that deliver high-energy light (laser) into the lesion through skin puncturing (percutaneous). The procedure is performed under ultrasound imaging guidance (ultrasound-guided). The destruction of the lesion occurs through overheating and coagulation. PLA, however, still needs a large-scale validation trial in order to be considered as an effective alternative to both surgery or follow-up for low-risk PTMC in elderly patients and/or in patients with co-morbidities that might expose the patients to a high surgical risk.
After a comprehensive information, patients will be consecutively assigned to Group 1 (surgery, preferentially lobectomy) or to Group 2 (percutaneous laser ablation, performed according to the attached procedure).Peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered.
The aims of this study are as follows: 1.To establish the rate of cure or partial ablation; 2.To compare the complication rate, time expenditure and costs of two procedures; 3.To assess changes in thyroid function and the need of substitution therapy with two procedures; 4.To assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and PLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous laser ablation(PLA) | Experimental | Procedure: PLAEligible participants with PTMC will be randomly assigned to this group and undergo percutaneous laser ablation(PLA). All the process is under the detection of real-time ultrasound.After surgery, all the patients will accept contrast-enhanced ultrasound(CEUS), regular ultrasound follow-up, thyroid functional detection, fine-needle aspiration biopsy(FNAB), neck CT.Per and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered. |
| Surgery | Active comparator | Procedure: Thyroid SurgeryEligible participants with PTMC will be randomly assigned to this group and undergo total/subtotal thyroid surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed PTMC (maximun diameter> = 5 mm and < = 10 mm) proved by fine needle aspiration biopsy with good thyroid function;
- Age≥ 18 Y;
- Single nodule without thyroid capsule contact;
- There had more than 3mm distance between nodules and trachea, carotid artery, recurrent laryngeal nerve (The distance should up to 5mm after injection of isolation fluid);
- No coarse calcification or eggshell-like calcification;
Key exclusion criteria (9 listed)
- Multifocal PTMC;
- Combined with other types of thyroid cancer or hyperthyroidism;
- Lesion contact with thyroid capsule or located in the isthmus;
- Serious coagulation dysfunction;
- Contralateral vocal cord paralysis;
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 |
|---|---|---|
| PLADuring the PLA, the patient is in supine position with head extended: the physician, ultrasound assistant and trained nurse work within the sterile field. Under constant ultrasound image guidance and after local anesthesia by means of 2% xylocaine infiltration, thin needles (21G) are positioned in the thyroid lesion, within safety distance from the surrounding anatomical structures. A plane-cut tip fiber optics is inserted into the PTMC through the needle. The laser at 1064 nm wavelength is turned on for 10 minutes until the pre-established energy dose is attained. There is usually no pain or very limited pain. | Procedure or surgery | Percutaneous laser ablation(PLA) |
| Thyroid SurgeryPatients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat, placenta muscle are incised successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process. Finally patient is performed total thyroidectomy or subtotal thyroidectomy. | Procedure or surgery | Surgery |
Primary outcome
Serological examination of thyroid function
Time frame: up to 12 months
Hyperthyreosis or hypothyroidism.
2 secondary outcomes
Recurrence rate
Time frame: up to 12 months
Therapeutic Effect
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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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.
WeiWei Zhan, Ph.D principal investigator
Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLA and Thyroid Surgery in people with Thyroid Cancer and Treatment Related Cancer, run by WeiWei Zhan at 13 sites in 2 countries.
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 9 inclusion and 9 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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China, Italy. 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 Lu Zhang (+8615021590551, aluer2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological examination of thyroid function (time frame: up to 12 months). 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 19 Mar 2021.