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A single-center, prospective, randomized controlled clinical trial: comparison between single-utility and multiportal Robot-assisted Thoracoscopic Surgery in the treatment of non-small cell lung cancer

A single-center, prospective, randomized controlled clinical trial: comparison between single-utility and multiportal Robot-assisted Thoracoscopic Surgery in the treatment of non-small cell lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044385
Enrollment
Unknown
Registered
2021-03-17
Start date
2021-03-15
Completion date
Unknown
Last updated
2021-09-07

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

Conditions

non-small cell lung cancer

Interventions

Experimental Group:Lung surgery with single-utility portal RATS
Control Group:Lung surgery with multiportal RATS

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 to 80 years; 2. No distant metastasis in preoperative clinical evaluation; 3. It is expected that the patients undergoing single lobectomy + hilar, mediastinal lymph node resection/sampling or single segment resection + hilar, mediastinal lymph node resection/sampling with RATS can obtain R0 surgical results; 4. Pulmonary function examination evaluates FEV1>=1L, and is greater than or equal to 50% of the predicted value; 5. The preoperative ECOG physical status score is 0/1; 6. ASA score I-III; 7. Volunteer to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Quit smoking time < 2 weeks; 2. The lesion expected to perform combined lobectomy/lobe sleeve resection; 3. Pregnant or breastfeeding women; 4. Suffering a serious mental illness; 5. History of other malignant diseases within 5 years; 6. A history of unstable angina or myocardial infarction within 6 months, coronary angiography; suggesting severe stenosis of the main branches of the coronary arteries; 7. History of cerebral infarction or cerebral hemorrhage within 6 months; 8. A history of continuous systemic corticosteroid therapy within 1 month; 9. Patient is not suitable for inclusion in the trial judged by the investigators.

Design outcomes

Primary

MeasureTime frame
Postoperative VAS pain score;

Secondary

MeasureTime frame
Duration of surgery;Blood loss;Number of lymph nodes dissected;Postoperative drainage;Postoperative extubation time;Incidence of postoperative adverse events;Reinsertion rate after extubation;Postoperative hospital stay;Postoperative hospitalization expenses;Incidence of readmission 30 days after discharge;3-year disease-free survival rate;5-year disease-free survival;5-year overall survival rate;30-day mortality rate after surgery;

Countries

China

Contacts

Public ContactLuo Qingquan

Shanghai Chest Hospital

qingquanluo@hotmail.com+86 18017320250

Outcome results

None listed

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