Surgery for Masaoka-Koga I-II Thymoma

Not Applicable

Completed

• Conditions: Thymoma; Masaoka Stage II; Masaoka Stage I
• Interventions: Procedure: the subxiphoid approach thoracoscopic thymectomy; Procedure: the lateral intercostal approach thoracoscopic thymectomy

• Registration Number: NCT05001113
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Study Start: 2021-08-15
• Primary Completion: 2022-02-15
• Study Completion: 2022-08-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the subxiphoid approach thoracoscopic thymectomy	the subxiphoid approach thoracoscopic thymectomy	The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.
the lateral intercostal approach thoracoscopic thymectomy	the lateral intercostal approach thoracoscopic thymectomy	The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients.

Primary Outcome Measures

Name	Time	Method
Dosage of analgesic medication after surgery	Up to the date of hospital discharge since the data of completion of surgery, up to 7 days	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.
Visual Analog Scales scores for postoperative pain	Up to the date of hospital discharge since the data of completion of surgery, up to 7 days	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.
Postoperative hospital stay	Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Operative time	The duration until the finish of surgery since the start of the surgery, up to 5 hours	Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin).
Perioperative blood loss	The duration until the finish of surgery since the start of the surgery, up to 5 hours	The volume of bleeding during the surgery.
Rate of conversion to open thoracotomy	Up to the end of follow-up since the date of randomization, up to 6 months.	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%.
Volume of postoperative drainage	Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days	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.
Postoperative treatment-related complications	Up to the date of hospital discharge since the data of completion of surgery, up to 7 days.	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.
Chronic postsurgical pain	Up to the end of follow-up since the date of hospital discharge, up to 6 months.	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)".
EORTC QLQ-C30 score for overall quality of life	Up to the end of follow-up since the date of randomization, up to 6 months.	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.

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China