Clinical trial NCT05001113: Surgery for Masaoka-Koga I-II Thymoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thymoma
Masaoka Stage I
Masaoka Stage II
Keywords: thymoma (Masaoka Stage I-II)
the subxiphoid approach
the lateral intercostal approach
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Zhongshan Hospital (Xiamen), Fudan University
name: Xuhui Central Hospital, Shanghai
name: Shanghai Minhang Central Hospital
name: Shanghai Qingpu Central Hospital
First posted: 2021-08-11
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dosage of analgesic medication after surgery
timeFrame: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days
measure: Visual Analog Scales scores for postoperative pain
timeFrame: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days
measure: Postoperative hospital stay
timeFrame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Secondary outcomes:
measure: Operative time
timeFrame: The duration until the finish of surgery since the start of the surgery, up to 5 hours
measure: Perioperative blood loss
timeFrame: The duration until the finish of surgery since the start of the surgery, up to 5 hours
measure: Rate of conversion to open thoracotomy
timeFrame: Up to the end of follow-up since the date of randomization, up to 6 months.
measure: Volume of postoperative drainage
timeFrame: Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
measure: Postoperative treatment-related complications
timeFrame: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days.
measure: Chronic postsurgical pain
timeFrame: Up to the end of follow-up since the date of hospital discharge, up to 6 months.
measure: EORTC QLQ-C30 score for overall quality of life
timeFrame: Up to the end of follow-up since the date of randomization, up to 6 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Lijie Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: