Clinical trial · Interventional
Surgery for Masaoka-Koga I-II Thymoma
Comparison of Safety and Perioperative Outcomes of Subxiphoid Approach Versus Lateral Intercostal Approach Thoracoscopic Thymectomy for Masaoka-Koga I-II Thymoma: A Prospective, Open, Multi-center, Phase II Randomized Controlled Trial
NCT05001113CI-TRIAL-00060932completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to evaluate the safety and perioperative outcomes of the subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for Masaoka-Koga I-II thymoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Masaoka Stage I | — | UNRESOLVED | — |
| Masaoka Stage II | — | UNRESOLVED | — |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the lateral intercostal approach thoracoscopic thymectomy | Procedure | — | UNRESOLVED |
| the subxiphoid approach thoracoscopic thymectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the subxiphoid approach thoracoscopic thymectomy
- description
- The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.
- interventionNames
- Procedure: the subxiphoid approach thoracoscopic thymectomy
- type
- ACTIVE_COMPARATOR
- label
- the lateral intercostal approach thoracoscopic thymectomy
- description
- The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients.
- interventionNames
- Procedure: the lateral intercostal approach thoracoscopic thymectomy
Primary outcomes (3)
- measure
- Dosage of analgesic medication after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II); 2. The patients whose tumor diameter was \<6 cm; 3. The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months; 4. ASA grade:1-2; 5. The patients should have no functional disorders in main organs.; 6. The patients should be able to understand our research and sign the informed consent. Exclusion Criteria: 1. Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; 2. Patients with myasthenia gravis; 3. Patients had undergone a sternotomy; 4. The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; 5. The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; 6. Female who is positive for serum pregnancy test or during lactation period; 7. The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; 8. The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; 9. The patients attend other clinical trials.
References
Publications (1)
- DERIVEDWang S, Yang X, Jiang J, Lin M, Fan H, Zhang Z, Xia H, Wang H, Liang F, Ding J, Tan L. Subxiphoid versus lateral intercostal thoracoscopic thymectomy for suspected thymoma: Results of a randomized controlled trial. J Thorac Cardiovasc Surg. 2024 Jul;168(1):290-298. doi: 10.1016/j.jtcvs.2023.10.040. Epub 2023 Oct 27. PMID 37890660