NCT07033572

Brief Summary

This study evaluates a thyroid-function-preserving alternative to routine total thyroidectomy for bilateral papillary thyroid carcinoma (PTC). Eligible adults undergo remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI dissection on the dominant side, followed by ultrasound-guided radiofrequency ablation (RFA) of a ≤7 mm contralateral focus during the same anesthesia. Outcomes include structural-recurrence-free survival, endocrine-function preservation, safety, and quality of life over 24 months.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jun 2018Jun 2028

Study Start

First participant enrolled

June 1, 2018

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

8.1 years

First QC Date

June 13, 2025

Last Update Submit

July 1, 2025

Conditions

Thyroid NeoplasmsCarcinoma, Papillary

Keywords

Hybrid endoscopic thyroidectomyRadiofrequency ablationThyroid function preservationBilateral Thyroid Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Structural Recurrence-Free Survival

    Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology.

    24 months

  • Endocrine-Function Preservation

    Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation).

    24 months

Secondary Outcomes (4)

  • Permanent RLN Palsy Incidence

    12 months

  • Permanent Hypocalcemia Incidence

    12 months

  • Nodule Volume Reduction Rate

    12 months

  • Procedure-Related Adverse Events

    30 days

Study Arms (1)

Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA

EXPERIMENTAL

Remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI central-neck dissection on the dominant lobe, immediately followed-under the same anesthesia-by ultrasound-guided radiofrequency ablation (17-G, 0.7 cm active tip, 40 W, moving-shot technique) of a ≤ 7 mm contralateral papillary thyroid microcarcinoma.

Procedure: Endoscopic Hemithyroidectomy with Central-Neck DissectionProcedure: Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule

Interventions

Endoscopic Hemithyroidectomy with Central-Neck DissectionPROCEDURE

Gas-less axillo-breast approach (trans-axillary + peri-areolar), carbon-dioxide-free working space, removing dominant thyroid lobe plus level VI lymph nodes; intra-operative neuromonitoring used throughout.

Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA
Ultrasound-Guided Radiofrequency Ablation of Contralateral NodulePROCEDURE

17-gauge internally-cooled electrode, 0.7 cm active tip, power 40 W; moving-shot technique under real-time ultrasound until hyperechoic halo fully covers ≤ 7 mm papillary microcarcinoma ≥ 2 mm from posterior capsule; same anesthesia session as surgery.

Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years.
  • Dominant-side PTC ≤1.5 cm suitable for endoscopic resection.
  • Contralateral nodule ≤7 mm located ≥2 mm from posterior capsule.
  • No radiologic lymph-node metastasis on contralateral side.
  • Written informed consent.

You may not qualify if:

  • Extrathyroidal extension, gross nodal or distant metastasis.
  • Prior neck surgery, prior RFA/ethanol injection, or neck irradiation.
  • Pregnancy or lactation.
  • Serious comorbidities precluding anesthesia or follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid NeoplasmsCarcinoma, Papillary

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

  • Bo Wang MD, Principal Investigator

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Wang Professor, MD

CONTACT

+13959123550wangbo@fjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 24, 2025

Study Start

June 1, 2018

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2028

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)