Surgery for Masaoka-Koga I-II Thymoma

Shanghai Zhongshan Hospital101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Thymoma Masaoka Stage I Masaoka Stage II

Interventions

the subxiphoid approach thoracoscopic thymectomyPROCEDURE

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.

the lateral intercostal approach thoracoscopic thymectomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month

Secondary Outcomes

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).

Time frame: The duration until the finish of surgery since the start of the surgery, up to 5 hours

Perioperative blood loss

The volume of bleeding during the surgery.

Time frame: The duration until the finish of surgery since the start of the surgery, up to 5 hours

Data from ClinicalTrials.gov

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