The Clinical Outcomes and Prediction of Thermal Ablation... | NCT06316895

Studies
The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT06316895

Sponsor

Chinese PLA General Hospital

Status

Recruiting

Last Update Posted

Mar 20, 2026Actual

Enrollment

3,772Estimated

Phase

Not provided

Conditions

Papillary Thyroid Cancer

Interventions

thyroid surgery
ultrasound-guided thermal ablation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Apr 1, 2027Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Feb 16, 2024

First Submission Date that Met QC Criteria

Mar 16, 2024

First Posted Date

Mar 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yu-kun Luo, Director, Head of Department of Ultrasound, Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,772Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgery group		patients with low-risk papillary thyroid carcinoma who chose thyroid surgery	Procedure: thyroid surgery
ablation group		patients with low-risk papillary thyroid carcinoma who chose thermal ablation	Procedure: ultrasound-guided thermal ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thyroid surgery	Procedure	thyroid lobectomy	surgery group
ultrasound-guided thermal ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of disease progression	cervical lymph node metastases, recurrent tumors and persistent tumors	more than 5 year

Secondary Outcomes

Measure	Description	Time Frame
Rate of complications	surgery or ablation complications	1week
Rate of tumor disappearance	complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients age between 18 and 80 year old, both sex
papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
the largest diameter ≤2.0 cm
no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT
follow-up period ≥12 months,

Exclusion Criteria:

patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
history of neck radiation
history of thyroid surgery
coagulation disorder
serious heart, respiratory, liver, or renal failure
dysfunction of the vocal cord on the opposite side

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with low-risk papillary thyroid carcinoma who choose surgery or thermal ablation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Yan, MD	Contact	13811237313	86	gemma-y@163.com

Overall Officials

Name	Affiliation	Role
Yukun Luo	Chinese PLA General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077273	Thyroid Cancer, Papillary

Ancestor Terms

ID	Term
D000231	Adenocarcinoma, Papillary
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020728	Transurethral Resection of Prostate

Ancestor Terms

ID	Term
D011468	Prostatectomy
D013521	Urologic Surgical Procedures, Male
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided