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Comparison of Endoscopic versus Open Surgery in Local Control Rates of Head and Neck Malignancies: A Single-Center, Prospective, Randomized, Open-Label, Blinded Endpoint, Non-inferiority Trial

Comparison of Endoscopic versus Open Surgery in Local Control Rates of Head and Neck Malignancies: A Single-Center, Prospective, Randomized, Open-Label, Blinded Endpoint, Non-inferiority Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079601
Enrollment
Unknown
Registered
2024-01-08
Start date
2024-01-15
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tumor

Interventions

Endoscopic Neck dissection:Endoscopic Neck Dissection
Endoscopic Parotidectomy:Endoscopic Parotidectomy
Endoscopic Submandibular Gland Resection:Endoscopic Submandibular Gland Resection
Conventional Neck Dissection:Conventional Neck Dissection
Conventional Parotidectomy:Conventional Parotidectomy
Conventional Submandibular Gland Resection:Conventional Submandibular Gland Resection

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: Project One: Endoscopic Oral Cancer Surgery with Concurrent Neck Lymph Node Dissection 1.Participants must be at least 16 years of age and not exceed 70 years. 2.Volunteers willing to participate and sign an "Informed Consent Form." 3.Patients capable of undergoing extended resection through the mouth without additional facial or neck scarring, following tumor localization and excision. 4.Clinically assessed as cN0/N1 via enhanced CT, necessitating neck lymph node dissection. 5.Postoperative follow-up of no less than two years, with a valid email, WeChat ID, or phone number. Project Two: Endoscopic Surgery for Malignant Parotid Gland Tumors 1.Subjects must be at least 16 years of age and not exceed 70 years. 2.Volunteers willing to participate and sign an "Informed Consent Form." 3.T1/T2 stage malignant parotid gland tumors with a diameter =2cm, without skin invasion. 4.Postoperative follow-up of no less than two years, with a valid email, WeChat ID, or phone number. Project Three: Endoscopic Surgery for Malignant Submandibular Gland Tumors 1.Participants must be at least 16 years of age and not exceed 70 years. 2.Volunteers willing to participate and sign an "Informed Consent Form." 3.Malignant tumors within the submandibular gland as determined by enhanced CT, without invasion of the hypoglossal nerve. 4.Postoperative follow-up of no less than two years, with a valid email, WeChat ID, or phone number.

Exclusion criteria

Exclusion criteria: Project One: Endoscopic Oral Cancer Surgery with Concurrent Neck Lymph Node Dissection 1.Patients with invasion of vital neck arteries or veins, skin invasion, or extensive neck metastasis. 2.Patients with recurrent tumors, metastatic tumors, a history of neck radiotherapy or chemotherapy, previous neck surgery, or trauma. 3.Patients with less than two years of postoperative follow-up or survival time, or without valid contact information. Project Two: Endoscopic Surgery for Malignant Parotid Gland Tumors 1.Tumors with a diameter >2cm, invading the external auditory canal, bone, or showing extensive metastasis. 2.Patients with recurrent tumors, metastasis to the parotid gland from other tumors, a history of previous surgery in the parotid region, radiotherapy, or trauma. 3.Patients with less than two years of postoperative follow-up or survival time, or without valid contact information. Project Three: Endoscopic Surgery for Malignant Submandibular Gland Tumors 1.Tumors breaching the submandibular gland capsule, invading the hypoglossal nerve, bone, or with extensive metastasis. 2.Patients with recurrent tumors, metastasis to the submandibular gland from other tumors, a history of previous surgery in the submandibular area, radiotherapy, or trauma. 3.Patients with less than two years of postoperative follow-up or survival time, or without valid contact information.

Design outcomes

Primary

MeasureTime frame
Local control rate;

Secondary

MeasureTime frame
Gender;Age;Length of incision;Diameter of tumor;Extent of surgical resection;Histopathology;Intraparotid lymph node metastasis;Intraoperative procedure;Operating time;Intraoperative blood loss;Drain collection;Duration of hospital stay;Postoperative complications;

Countries

China

Contacts

Public ContactHanBo

West China Hospital of Stomatology, Sichuan University

paulhanbo@163.com+86 138 8180 8380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026