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Surgery for Masaoka-Koga I-II Thymoma

Primary Purpose

Thymoma, Masaoka Stage I, Masaoka Stage II

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the subxiphoid approach thoracoscopic thymectomy
the lateral intercostal approach thoracoscopic thymectomy
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma focused on measuring thymoma (Masaoka Stage I-II), the subxiphoid approach, the lateral intercostal approach

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the subxiphoid approach thoracoscopic thymectomy

the lateral intercostal approach thoracoscopic thymectomy

Arm Description

The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.

The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
Perioperative blood loss
The volume of bleeding during the surgery.
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%.
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.
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.
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)".
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.

Full Information

First Posted
July 12, 2021
Last Updated
September 16, 2022
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Zhongshan Hospital (Xiamen), Fudan University, Xuhui Central Hospital, Shanghai, Shanghai Minhang Central Hospital, Shanghai Qingpu Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05001113
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Zhongshan Hospital (Xiamen), Fudan University, Xuhui Central Hospital, Shanghai, Shanghai Minhang Central Hospital, Shanghai Qingpu Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Masaoka Stage I, Masaoka Stage II
Keywords
thymoma (Masaoka Stage I-II), the subxiphoid approach, the lateral intercostal approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the subxiphoid approach thoracoscopic thymectomy
Arm Type
Experimental
Arm Description
The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.
Arm Title
the lateral intercostal approach thoracoscopic thymectomy
Arm Type
Active Comparator
Arm Description
The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients.
Intervention Type
Procedure
Intervention Name(s)
the subxiphoid approach thoracoscopic thymectomy
Other Intervention Name(s)
SATT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
the lateral intercostal approach thoracoscopic thymectomy
Other Intervention Name(s)
LATT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dosage of analgesic medication after surgery
Description
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
Title
Visual Analog Scales scores for postoperative pain
Description
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
Title
Postoperative hospital stay
Description
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 Outcome Measure Information:
Title
Operative time
Description
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
Title
Perioperative blood loss
Description
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
Title
Rate of conversion to open thoracotomy
Description
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%.
Time Frame
Up to the end of follow-up since the date of randomization, up to 6 months.
Title
Volume of postoperative drainage
Description
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.
Time Frame
Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
Title
Postoperative treatment-related complications
Description
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.
Time Frame
Up to the date of hospital discharge since the data of completion of surgery, up to 7 days.
Title
Chronic postsurgical pain
Description
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)".
Time Frame
Up to the end of follow-up since the date of hospital discharge, up to 6 months.
Title
EORTC QLQ-C30 score for overall quality of life
Description
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.
Time Frame
Up to the end of follow-up since the date of randomization, up to 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II); The patients whose tumor diameter was <6 cm; The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months; ASA grade：1-2; The patients should have no functional disorders in main organs.; The patients should be able to understand our research and sign the informed consent. Exclusion Criteria: Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; Patients with myasthenia gravis; Patients had undergone a sternotomy; 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; 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; Female who is positive for serum pregnancy test or during lactation period; The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; The patients attend other clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijie Tan, MD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

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Surgery for Masaoka-Koga I-II Thymoma

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