Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
304 participants
INTERVENTIONAL
2023-11-20
2030-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RATS for Thymectomy
The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted.
RATS for Thymectomy
a minimally invasive surgical type for Thymoma: RATS
VATS for Thymectomy
The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.
VATS for Thymectomy
a minimally invasive surgical type for Thymoma: VATS
Interventions
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RATS for Thymectomy
a minimally invasive surgical type for Thymoma: RATS
VATS for Thymectomy
a minimally invasive surgical type for Thymoma: VATS
Eligibility Criteria
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Inclusion Criteria
2. ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms.
3. ) need to accept thymectomy surgery ;
4. ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ;
5. ) The maximum diameter of the lesion \< 5cm ;
6. ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ;
7. ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ;
8. ) Preoperative major organ function meets the following criteria : Bone marrow function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14 days before platelet count examination ) ; coagulation function : INR and PT \< 1.5 × ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min ( calculated according to the Cockcroft-Gault formula ) ;
9. ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan.
Exclusion Criteria
2. ) had undergone mediastinal surgery or cardiac surgery ;
3. ) body mass index ( BMI ) ≥ 30 ;
4. ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ;
5. ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ;
6. ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ;
7. ) patients with other malignant tumors or hematological diseases ;
8. ) combined with chronic pain or preoperative use of opioid analgesics ;
9. ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ;
10. ) have mental disorders, such as anxiety disorders ;
11. ) pregnant and/or lactating women ;
12. ) is currently participating in other interventional clinical studies.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Deping Zhao
Administrative Director of Thoracic Surgery Department
Principal Investigators
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Deping Zhao, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, , China
Countries
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Central Contacts
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Facility Contacts
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Junqiang Fan
Role: primary
Other Identifiers
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STAR006
Identifier Type: -
Identifier Source: org_study_id
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