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| Name | Class |
|---|---|
| Zhongshan Hospital (Xiamen), Fudan University | OTHER |
| Xuhui Central Hospital, Shanghai | OTHER |
| Shanghai Minhang Central Hospital | OTHER |
| Shanghai Qingpu Central Hospital |
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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.
It is a multi-center, open, prospective randomized phase II&III clinical trial sponsored by Shanghai Zhongshan Hospital with other four hospitals in China participating in. 100 patients with thymoma (Masaoka-Koga I-II ) diagnosed by enhanced computed tomography were recruited and randomly assigned into the subxiphoid approach thoracoscopic thymectomy (SATT group) and the lateral intercostal approach thoracoscopic thymectomy (LATT group) according to the proportion of 1:1. The safety and perioperative outcomes are compared between the two surgical regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the subxiphoid approach thoracoscopic thymectomy | Experimental | The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients. |
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| the lateral intercostal approach thoracoscopic thymectomy | Active Comparator | The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the subxiphoid approach thoracoscopic thymectomy | Procedure | A 2-cm straight incision was made in the middle of the xiphoid process, the incision was used as a thoracoscope hole, and the xiphoid process could be removed if necessary. The surgeon used the oval forceps to release the left and right soft tissue gaps behind the sternum, from the anterior mediastinum tunnel. Two 0.5 cm extrapleural thoracic ports under the bilateral costal arches were created, and this incision was used as an operation hole. The thread puncture cone with a diameter of 0.5 cm was placed under the guidance of the finger. |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage of analgesic medication after surgery | The dosage of postoperative analgesic medication was the sum of the dosage of analgesics used for managing the pain of the patient after surgery. The analgesic medication includes analgesics in patient-controlled epidural analgesia (PCIA), injections, and oral medication. | Up to the date of hospital discharge since the data of completion of surgery, up to 7 days |
| Visual Analog Scales scores for postoperative pain | The postoperative pain was evaluated for every enrolled patient by using the Visual Analog Scales (VAS). VAS: it typically asks a patient to place a mark on a line indicating the level of pain from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible. | Up to the date of hospital discharge since the data of completion of surgery, up to 7 days |
| Postoperative hospital stay | Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery. The criteria of hospital discharge were defined as with the volume of postoperative drainage < 200 ml/day, a normal chest X-ray, and good physical condition. | Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin). | The duration until the finish of surgery since the start of the surgery, up to 5 hours |
| Perioperative blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lijie Tan, MD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37890660 | Derived | Wang 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. |
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According to the regulations on the management of human genetic resources of the People's Republic of China, we will not be able to share Individual Participant Data
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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| UNKNOWN |
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| the lateral intercostal approach thoracoscopic thymectomy | Procedure | Right-side approach: Use the left supine position. The observing port was created at the right axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces. Left-side approach: Use the right supine position. The observing port was created at the left axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces. |
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The volume of bleeding during the surgery. |
| The duration until the finish of surgery since the start of the surgery, up to 5 hours |
| Rate of conversion to open thoracotomy | It was the proportion of operations with unplanned conversion to thoracotomy in total operations in every group. The formula： Number (operations with unplanned conversion to thoracotomy in every group) / 50 * 100%. | Up to the end of follow-up since the date of randomization, up to 6 months. |
| Volume of postoperative drainage | The volume of postoperative drainage of the patient was the sum of his daily drainage volume after the surgery. The types of drainage equipment include the thorax close drainage equipment and the unidirectional negative-pressure drainage ball. | Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days |
| Postoperative treatment-related complications | Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0. | Up to the date of hospital discharge since the data of completion of surgery, up to 7 days. |
| Chronic postsurgical pain | An updated definition of chronic postsurgical pain (CPSP) was proposed by Werner and Kongsgaard in 2014. The proposed definition of CPSP was "pain persisting at least three months after surgery, that was not present before surgery, or that had different characteristics or increased intensity from preoperative pain, localized to the surgical site or a referred area, and other possible causes of the pain were excluded (e.g., cancer recurrence, infection)". | Up to the end of follow-up since the date of hospital discharge, up to 6 months. |
| EORTC QLQ-C30 score for overall quality of life | Overall quality of life is respectively evaluated at randomization and 1 month, 3 month, 6 month after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Scale (EORTC QLQ-C30) (V3.0). The minimum value of EORTC QLQ-C30 score was 0，and the maximum was 100. Zero indicates the worst quality of life, while 100 represents the best quality of life. | Up to the end of follow-up since the date of randomization, up to 6 months. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |