Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma

Papillary Thyroid Carcinoma Clinical Trial

Official title:

A Prospective Multicenter Study to Compare the Therapeutic Outcomes of Microwave Ablation With Surgical Resection for Micropapillary Thyroid Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04197960
• Other study ID #: 301jrcsk-lp
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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 + central lymph node dissection. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 973
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma
• Papillary Thyroid Carcinoma
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Microwave ablation
Use thermal energy to destroy tumor
• Surgical resection
Resect tumors

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local tumor progression	the number of patients with tumor progression around the treated area	2-year
Primary	lymph node metastasis	the number of patients with lymph node metastasis	2-year
Primary	distant metastasis	the number of patients with thyroid cancer metastasizing to distant tissues or organs	2-year
Primary	New thyroid cancer	the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland	2-year
Primary	Disease progression	the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.	2-year
Secondary	complication rate	complication rate encouned during or after procedures	2-year
Secondary	blood loss	the volume of blood loss during procedures	2-year
Secondary	free thyroxine	change of free thyroxine concentration	2-year
Secondary	free triiodothyronine	change of free triiodothyronine concentration	2-year
Secondary	thyroid-stimulating hormone	change of thyroid-stimulating hormone concentration	2-year