ThymomaNCT05001113
Surgery for Masaoka-Koga I-II Thymoma
A study testing the subxiphoid approach thoracoscopic thymectomy and the lateral intercostal approach thoracoscopic thymectomy in people with Thymoma and Masaoka Stage I, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymoma, Masaoka Stage I, Masaoka Stage II
- What is being tested?
- the subxiphoid approach thoracoscopic thymectomy and the lateral intercostal approach thoracoscopic thymectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2021to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Thymoma, Masaoka Stage I, Masaoka Stage II
- Being tested
- the subxiphoid approach thoracoscopic thymectomy, the lateral intercostal approach thoracoscopic thymectomy
- Keywords
- thymoma (Masaoka Stage I-II), the subxiphoid approach, the lateral intercostal approach
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the subxiphoid approach thoracoscopic thymectomyProcedure or surgery
Also called SATT
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 or surgery
Also called LATT
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.
| Study group | Role | What they receive |
|---|---|---|
| the subxiphoid approach thoracoscopic thymectomy | Experimental | The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients. Receives: Procedure: the subxiphoid approach thoracoscopic thymectomy |
| the lateral intercostal approach thoracoscopic thymectomy | Active comparator | The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients. Receives: Procedure: the lateral intercostal approach thoracoscopic thymectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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)".
Measured: 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.
Measured: Up to the end of follow-up since the date of randomization, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start15 Aug 2021
- Primary completion15 Feb 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThymomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan Hospital (Xiamen), Fudan University, Xuhui Central Hospital, Shanghai, Shanghai Minhang Central Hospital, Shanghai Qingpu Central Hospital
- Responsible party
- Sponsor
- Investigators
- Lijie Tan, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001113
- Sponsor's protocol ID
- B2021-454
- Status last verified
- Sep 2022
- First submitted
- 12 Jul 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Wang S, Yang X, Jiang J, Lin M, Fan H, Zhang Z, Xia H, Wang H, Liang F, Ding J, Tan L. Subxiphoid versus lateral intercostal thoracoscopic thymectomy for suspected thymoma: Results of a randomized controlled trial. J Thorac Cardiovasc Surg. 2024 Jul;168(1):290-298. doi: 10.1016/j.jtcvs.2023.10.040. Epub 2023 Oct 27.
PubMed 37890660
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05001113
- Acronym / sponsor ID
- B2021-454
- Conditions
- Thymoma, Masaoka Stage I, Masaoka Stage II
- Keywords
- thymoma (Masaoka Stage I-II), the subxiphoid approach, the lateral intercostal approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Zhongshan Hospital (Xiamen), Fudan University, Xuhui Central Hospital, Shanghai, Shanghai Minhang Central Hospital, Shanghai Qingpu Central Hospital
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the subxiphoid approach thoracoscopic thymectomy | Experimental | Procedure: the subxiphoid approach thoracoscopic thymectomyThe subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients. |
| the lateral intercostal approach thoracoscopic thymectomy | Active comparator | Procedure: the lateral intercostal approach thoracoscopic thymectomyThe lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the subxiphoid approach thoracoscopic thymectomyAlso: SATTA 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. | Procedure or surgery | the subxiphoid approach thoracoscopic thymectomy |
| the lateral intercostal approach thoracoscopic thymectomyAlso: LATTRight-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. | Procedure or surgery | the lateral intercostal approach thoracoscopic thymectomy |
Primary outcome
Dosage of analgesic medication after surgery
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Operative time
Time frame: The duration until the finish of surgery since the start of the surgery, up to 5 hours
Perioperative blood loss
Time frame: The duration until the finish of surgery since the start of the surgery, up to 5 hours
Rate of conversion to open thoracotomy
Time frame: Up to the end of follow-up since the date of randomization, up to 6 months.
Volume of postoperative drainage
Time frame: Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
Postoperative treatment-related complications
Time frame: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days.
Chronic postsurgical pain
Time frame: 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
Time frame: Up to the end of follow-up since the date of randomization, up to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 37890660Wang S, Yang X, Jiang J, Lin M, Fan H, Zhang Z, Xia H, Wang H, Liang F, Ding J, Tan L. Subxiphoid versus lateral intercostal thoracoscopic thymectomy for suspected thymoma: Results of a randomized controlled trial. J Thorac Cardiovasc Surg. 2024 Jul;168(1):290-298. doi: 10.1016/j.jtcvs.2023.10.040. Epub 2023 Oct 27.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijie Tan, MD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the subxiphoid approach thoracoscopic thymectomy and the lateral intercostal approach thoracoscopic thymectomy in people with Thymoma and Masaoka Stage I, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of analgesic medication after surgery (time frame: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05001113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.