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A clinical randomized controlled study of Da Vinci robot versus traditional expanded resection in the treatment of early oropharyngeal carcinoma

A clinical randomized controlled study of Da Vinci robot versus traditional expanded resection in the treatment of early oropharyngeal carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035415
Enrollment
Unknown
Registered
2020-08-10
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

oropharyngeal cancer

Interventions

control group:Extended excision of oropharyngeal cancer with temporary disconnection of the mandible
experimental group:Extended excision of oropharyngeal with Da Vinci robot through mouth

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years; 2. No restrictions on men or women; 3. Preoperative pathology indicated squamous cell carcinoma; 4. The primary site is the oropharynx (including tonsils, soft palate, base of tongue and side wall of pharynx); 5. Preoperative enhanced CT/MRI of maxillofacial region, chest CT or neck ultrasound were performed. The oral and oropharyngeal cancer must be staged in T1-2, N0, M0, according to the 8th edition of the AJCC; 6. Within 1 week before grouping, blood routine, coagulation function, liver function, renal function and ECG were normal (hemoglobin>80 g/L; absolute neutrophil count > 1.5 x 10^9/L, platelet > 100 x 10^9/L; bile red = 50 ml/min) 7. Functional oral feeding grades were performed one week before surgery, and those with grades 5-7 will be included in the trial.

Exclusion criteria

Exclusion criteria: 1. Complicated with other malignant tumor or recurrence of or primary tumor within 5 years; 2. History of severe drug allergy; 3. Patients with pregnancy, lactation or neurological disorders; 4. Patients who have participated in other clinical trials; 5. Patients who have received radiotherapy, chemotherapy and targeted drugs and other anti-tumor treatments before surgery; 6. Mouth opening < 3.5cm; 7. Contraindications associated with general anesthesia surgery (such as hypertension, diabetes etc, which are difficult to control with drugs); 8. Patients with congenital immune deficiency or organ transplantation; 9. Patients with diseases related to HBV, HCV, HIV, TRUST, etc..

Design outcomes

Primary

MeasureTime frame
Degree of wound healing;Postoperative complications;Swallowing quality of life questionnaire;Video fluoroscopic swallowing study;Primary lesion and neck condition;

Countries

China

Contacts

Public ContactChenping Zhang

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

zhang.chenping@hotmail.com+86 13601963045

Outcome results

None listed

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