NCT06398795 Dual-port Trans-subclavian Thyroid Endoscopic Surgery
| NCT ID | NCT06398795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Condition | Thyroid Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, single-center, open-label, non-randomized controlled real-world study aimed at exploring a novel approach to cavity construction for thyroid endoscopic surgery. The study seeks to evaluate its effectiveness and safety while accumulating further evidence-based medical data. Three hundred patients with thyroid tumors were divided into an experimental group (150 cases receiving a new endoscopic thyroid surgery technique, namely, dual-port trans-subclavian thyroid endoscopic surgery) and a control group (150 cases undergoing traditional open thyroid surgery) according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events are recorded detailly. The primary efficacy endpoint is a comparison of surgical complications between the two treatment groups. Secondary endpoints include: (1) levels of IL-2, IL-4, IL-6, IL-10, TNF-α, INF-γ, renin, angiotensin II, and aldosterone preoperatively and on the second day postoperatively; (2) NRS scores on the first day postoperatively; (3) length of hospital stay, duration of surgery, total treatment cost, and postoperative drainage volume; and (4) assessment of wound satisfaction during a three-month follow-up visit. Safety assessments include adverse events, vital signs, and pathological examinations.
Eligibility Criteria
Inclusion Criteria: * Thyroid cancer or benign thyroid tumors * Patients with a demand for incisional cosmetic improvement Exclusion Criteria: * Patients with thyroid cancer larger than 2 cm * benign tumors larger than 5 cm * Patients with severe underlying diseases * Patients with chronic kidney disease, * Patients with autoimmune diseases * Patients with rheumatoid arthritis
Contact & Investigator
Jiashu Wu, Profe
PRINCIPAL INVESTIGATOR
The first hospital of Wenzhou Medical University
Frequently Asked Questions
Who can join the NCT06398795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Thyroid Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06398795 currently recruiting?
Yes, NCT06398795 is actively recruiting participants. Contact the research team at 845095442@qq.com for enrollment information.
Where is the NCT06398795 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT06398795 clinical trial?
NCT06398795 is sponsored by First Affiliated Hospital of Wenzhou Medical University. The principal investigator is Jiashu Wu, Profe at The first hospital of Wenzhou Medical University. The trial plans to enroll 300 participants.