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

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.

Study Overview

• Status: Completed
• Conditions: Thymoma; Masaoka Stage I; Masaoka Stage II
• Intervention / Treatment: Procedure: the subxiphoid approach thoracoscopic thymectomy; Procedure: the lateral intercostal approach thoracoscopic thymectomy

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Shanghai Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the subxiphoid approach thoracoscopic thymectomy; The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.	Procedure: the subxiphoid approach thoracoscopic thymectomy; 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.; Other Names: SATT
Active Comparator: the lateral intercostal approach thoracoscopic thymectomy; The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients.	Procedure: the lateral intercostal approach thoracoscopic thymectomy; 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.; Other Names: LATT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai Minhang Central Hospital; Xuhui Central Hospital, Shanghai; Zhongshan Hospital (Xiamen), Fudan University; Shanghai Qingpu Central Hospital
• Investigators: Principal Investigator: Lijie Tan, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: thymoma (Masaoka Stage I-II); the subxiphoid approach; the lateral intercostal approach
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Thoracic Neoplasms; Neoplasms, Complex and Mixed; Thymoma; Thymus Neoplasms
• Other Study ID Numbers: B2021-454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No