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Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma

Primary Purpose

Papillary Thyroid Carcinoma

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microwave ablation
Surgical resection
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillary Thyroid Carcinoma focused on measuring Papillary Thyroid Carcinoma, Microwave ablation, Surgical resection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

microwave ablation

surgical resection

Arm Description

ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule.

lobectomy + central lymph node dissection

Outcomes

Primary Outcome Measures

local tumor progression
the number of patients with tumor progression around the treated area
lymph node metastasis
the number of patients with lymph node metastasis
distant metastasis
the number of patients with thyroid cancer metastasizing to distant tissues or organs
New thyroid cancer
the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland
Disease progression
the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.

Secondary Outcome Measures

complication rate
complication rate encouned during or after procedures
blood loss
the volume of blood loss during procedures
free thyroxine
change of free thyroxine concentration
free triiodothyronine
change of free triiodothyronine concentration
thyroid-stimulating hormone
change of thyroid-stimulating hormone concentration

Full Information

First Posted
December 4, 2019
Last Updated
August 3, 2022
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04197960
Brief Title
Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma
Official Title
A Prospective Multicenter Study to Compare the Therapeutic Outcomes of Microwave Ablation With Surgical Resection for Micropapillary Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 + 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Carcinoma
Keywords
Papillary Thyroid Carcinoma, Microwave ablation, Surgical resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
973 (Actual)

8. Arms, Groups, and Interventions

Arm Title
microwave ablation
Arm Type
Experimental
Arm Description
ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule.
Arm Title
surgical resection
Arm Type
Active Comparator
Arm Description
lobectomy + central lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
Use thermal energy to destroy tumor
Intervention Type
Procedure
Intervention Name(s)
Surgical resection
Intervention Description
Resect tumors
Primary Outcome Measure Information:
Title
local tumor progression
Description
the number of patients with tumor progression around the treated area
Time Frame
2-year
Title
lymph node metastasis
Description
the number of patients with lymph node metastasis
Time Frame
2-year
Title
distant metastasis
Description
the number of patients with thyroid cancer metastasizing to distant tissues or organs
Time Frame
2-year
Title
New thyroid cancer
Description
the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland
Time Frame
2-year
Title
Disease progression
Description
the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.
Time Frame
2-year
Secondary Outcome Measure Information:
Title
complication rate
Description
complication rate encouned during or after procedures
Time Frame
2-year
Title
blood loss
Description
the volume of blood loss during procedures
Time Frame
2-year
Title
free thyroxine
Description
change of free thyroxine concentration
Time Frame
2-year
Title
free triiodothyronine
Description
change of free triiodothyronine concentration
Time Frame
2-year
Title
thyroid-stimulating hormone
Description
change of thyroid-stimulating hormone concentration
Time Frame
2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Liang
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma

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