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A randomized, open-label clinical study comparing the safety of subxiphoid single and three-port thoracoscopic resection of mediastinal masses

A randomized, open-label clinical study comparing the safety of subxiphoid single and three-port thoracoscopic resection of mediastinal masses

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090313
Enrollment
Unknown
Registered
2024-09-27
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Mediastinal tumor

Interventions

Experimental group:Subxiphoid single-port approach
Control group:Subxiphoid three-hole approach

Sponsors

Liaoning Cancer Hospital &Insitute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Preoperative chest X-ray and/or chest CT plain scan + enhanced scan were performed to confirm the diagnosis of mediastinal masses. (2) No surgical contraindication was found in preoperative examination; (3) Suitable for thoracoscopic surgery without serious complications affecting the safety of surgery or postoperative recovery; (4) The age between 18-75 years old; (5) Estimated survival of more than 3 months without evidence of distant metastasis; (6) Minimally invasive resection of mediastinal mass evaluated by the surgeon.

Exclusion criteria

Exclusion criteria: (1) patients with previous radiotherapy and chemotherapy; (2) incomplete data; (3) After enrollment, the patient's condition changed and emergency surgery was confirmed by the doctor in charge; (4) patients with severe coagulopathy or receiving anticoagulant therapy; (5) to study the use of narcotic drugs or other drugs, patients with a history of allergies; (6) preoperative heart disease, such as severe heart failure; (7) pregnancy or lactation women; (8) with severe mental illness; (9) has a history of other malignant tumor diseases within five years; (10) history of cerebral infarction or cerebral hemorrhage within 6 months; A period of 6 months (11) has a history of unstable angina or myocardial infarction. The same period (12) for other diseases surgery; (13) patients receiving drugs from other clinical trials or participating in other interventional studies; (14) because of psychological, family or social reason to cooperate with this study, refused to sign the informed consent of the patients.

Design outcomes

Primary

MeasureTime frame
Duration of surgery;Modus operandi;Length of incision;Whether there was conversion to thoracotomy and the reasons for conversion;Intraoperative blood loss;Tumor location;Degree of radical resection (R0/R1/R2);Surgery related complications: intraoperative bleeding and damage (vital organs and structures, including blood vessel damage to extra blood loss);Intraoperative death;VAS score;The number of drainage tube;Drainage tube indwelling time;The average of Drainage;Hospital stays;Postoperative hospital stay;Hospitalization cost;Incision complications;Active bleeding in the chest;Chylothorax;Pneumonia;Cardiovascular and cerebrovascular events (including thrombosis, embolism, etc.);Peripheral blood routine;Blood biochemical index;The time of first ambulation;Daily maximum body temperature from postoperative to discharge;The time of first flatus/defecation/bowel sounds;The number of sputum suction postoperative bronchoscopy;After surgery to discharge amount before blood transfusion;Chronic pain;Constipation;CAP;

Secondary

MeasureTime frame
Blood transfusion volume;Anesthesia related complication;

Countries

China

Contacts

Public ContactLiang Zhang

Liaoning Cancer Hospital &Insitute

13998288410@163.com+86 189 0091 8167

Outcome results

None listed

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