NCT06468696

Brief Summary

The objective of this research is to investigate the clinical outcomes of modified surgical techniques such as omitting the cervical linea alba suture in transthoracic endoscopic thyroidectomy. Furthermore, the study requires the collection of normal thyroid tissues, benign and malignant thyroid tumors, and lymph nodes to further clarify the mechanisms associated with the initiation, progression, metastasis, and recurrence of thyroid cancer.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

June 3, 2024

Last Update Submit

June 20, 2024

Conditions

Papillary Thyroid CancerLymph Node MetastasisCarcinogenesis

Outcome Measures

Primary Outcomes (4)

  • Postoperative neck edema Incidence rate

    Postoperative neck edema Incidence rate

    Within one week post-surgery

  • Postoperative short-term pain

    Record the patient's perception of wound pain on postoperative days 1, 3, and 5 using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain), for quantification.

    Within one week post-surgery

  • Thyroid Papillary carcinoma tissue mRNA expression profile

    After extracting total RNA from tissue, it is purified and a cDNA library is constructed. Following library quality control, sequencing is conducted on the Illumina NovaSeq 6000 platform using the PE150 mode to obtain tissue mRNA expression data.

    Within one month after the transcriptome sequencing.

  • Thyroid papillary carcinoma metastatic lymph node mRNA expression profile

    After extracting total RNA from tissue, it is purified and a cDNA library is constructed. Following library quality control, sequencing is conducted on the Illumina NovaSeq 6000 platform using the PE150 mode to obtain tissue mRNA expression data.

    Within one month after the transcriptome sequencing.

Study Arms (6)

Suturing the cervical linea alba during endoscopic thyroid surgery

EXPERIMENTAL

Suturing the cervical linea alba during endoscopic thyroid surgery.

Procedure: Suturing the cervical linea alba during endoscopic thyroid surgery.

Not suturing the cervical linea alba during endoscopic thyroid surgery

NO INTERVENTION

Not suturing the cervical linea alba during endoscopic thyroid surgery.

Thyroid papillary carcinoma group

OTHER

Thyroid papillary carcinoma tissue.

Genetic: Performing transcriptome sequencing

Thyroid papillary carcinoma adjacent group

OTHER

Thyroid papillary carcinoma adjacent tissue.

Genetic: Performing transcriptome sequencing

Lymph node metastasis group

OTHER

Lymph node tissue with metastasis.

Genetic: Performing transcriptome sequencing

Non-lymph node metastasis group

OTHER

Lymph node tissue without metastasis.

Genetic: Performing transcriptome sequencing

Interventions

Suturing the cervical linea alba during endoscopic thyroid surgery.PROCEDURE

Suturing the cervical linea alba during endoscopic thyroid surgery.

Suturing the cervical linea alba during endoscopic thyroid surgery
Performing transcriptome sequencingGENETIC

Performing transcriptome sequencing

Lymph node metastasis groupNon-lymph node metastasis groupThyroid papillary carcinoma adjacent groupThyroid papillary carcinoma group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Perform transthoracic endoscopic thyroidectomy via breast approach;
  • Postoperative pathology confirms benign or malignant thyroid tumors;
  • Preoperative thyroid ultrasound or cervical CT suggests no extrathyroidal invasion or distant metastasis of the tumor;
  • No contraindications for general anesthesia;
  • Patients with cosmetic requirements.

You may not qualify if:

  • Underwent transthoracic endoscopic thyroidectomy;
  • Postoperative pathology confirmed as benign or malignant thyroid tumors;
  • Preoperative thyroid ultrasound or neck CT suggested no extraglandular invasion or distant metastasis of the tumor;
  • No contraindications to general anesthesia;
  • Patients with cosmetic demands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi'an Jiaotong University Second Affiliated Hospital

Xi'an, Shaanxi, 710049, China

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, PapillaryLymphatic MetastasisCarcinogenesis

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhidong Wang

    Xi'an Jiaotong University Second Affiliated Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhidong Wang, Professor

CONTACT

+86 138 9182 3580xawzd@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 21, 2024

Study Start

April 1, 2023

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

CN(1)