Mediastinal NeoplasmsPhase 3NCT03521986
Pain and Quality of Life After Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS
A Phase 3 study testing Subxiphoid uniportal VATS and Intercostal uniportal VATS in people with Mediastinal Neoplasms and Thoracic Neoplasm, run by Lei Jiang at 1 site in China.
Trial summary
Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used surgical methods, but there are some deficiencies.Minimally invasive surgery through the subxiphoid approach can achieve a good surgical field of vision. (1) The surgical field is fully exposed. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediastinal Neoplasms, Thoracic Neoplasm, Thoracic Surgery
- What is being tested?
- Subxiphoid uniportal VATS and Intercostal uniportal VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2018to 30 Oct 2023
- Phase
- Phase 3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of anterial and middle mediastinal tumors ;
- Normal heart function, pulmonary function FEV1 %> 60% PaO2> 80 mmHg
- BMI<30
Who cannot join
- enlargement of lymph nodes was seen in the clinical CT readings.
- Preoperative chronic pain or chronic opioid analgesics
- Preoperative check for mental disorders such as hyper-anxiety
- History of previous thoracic surgery
- Patients with thoracic deformity (eg, funnel chest and chicken breast)
- Poor education can not understand postoperative follow-up requirements and assessment scale
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200020
jian chen, +8618817310041, yufuchenjian@163.com
lei jiang, doctor
About this study
Official title: Postoperative Pain and Quality of Life for Patients Undergoing Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS:A Randomized Controlled Trial
Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used surgical methods, but there are some deficiencies.Minimally invasive surgery through the subxiphoid approach can achieve a good surgical field of vision. (1) The surgical field is fully exposed. (2) damage to intercostal nerves can be avoided.(3) Operation time, intraoperative blood loss, postoperative Extubation time is similar to VATS. But there is still lack of evidence.
In this study, 50 patients undergoing subxiphoid uniportal VATS and 50 patients undergoing intercostal uniportal VATS were included to evaluate the post-operative pain and quality of life after surgery.
Read the detailed description
The types of tumors in the medial mediastinal area were different. Thymoma, germ cell tumors, ectopic parathyroid tumors, and lymphoid tumors were in the anterior mediastinum. Bronchial cysts, pericardial cysts, and lymphomas were in the middle mediastinum. The principles of treatment for mediastinal tumor surgery must be both safe and radical. Radical resection is the dominant position in the treatment of mediastinal tumors, including traditional open surgery and thoracoscopic assisted minimally invasive surgery. At present, minimally invasive surgery for mediastinal tumor includes video-assisted thoracoscopic surgery via subxiphoid approach, left or right intercostal approach, trans-cervical approach and "Da Vinci" robotic system. Compared with conventional sternotomy, thoracoscopic assisted minimally invasive mediastinal tumor resection has clearer, multi-angle surgical vision, less trauma, less intraoperative blood loss, early postoperative extubation, and short postoperative hospital stay, postoperative recovery faster, less pain, fewer complications and meet the beauty needs and so on. Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used surgical methods, but there are some deficiencies.
Minimally invasive surgery through the subxiphoid approach can achieve a good surgical field of vision. Compared with the traditional transcostal VATS medial mediastinal tumor resection, the subxiphoid thoracoscopic surgery had obvious advantages: (1) The surgical field is fully exposed. For patients with myasthenia gravis, it is particularly necessary to clean bilateral mediastinal adipose tissue; (2) Without intercostal surgery, damage to intercostal nerves can be avoided, postoperative pain can be reduced, and quality of life can be improved; (3) Operation time, intraoperative blood loss, postoperative Extubation time is similar to VATS. Disadvantages are as follows: (1) If there is a large hemorrhage during surgery, an emergency transfer to open the chest is required. The injury is greater and the operation is more troublesome; (2) Anterior septal space is Smaller, surgical instruments are more likely to interfere with each other. But there is still lack of evidence to prove which is better.
In this study, 100 patients with anterial and middle mediastinal tumors were selected as study subjects. 50 patients undergoing subxiphoid uniportal VATS were included in the observation group, and 50 patients undergoing intercostal uniportal VATS were included in the control group. The operation time, incision length, intraoperative blood loss, postoperative drainage time, postoperative drainage, hospitalization and hospitalization costs of the 2 groups would be observed. The clinical efficacy and incidence of complications were compared between the 2 groups. After six months of follow-up, postoperative pain and postoperative quality of life were observed in the 2 groups.
- Conditions
- Mediastinal Neoplasms, Thoracic Neoplasm, Thoracic Surgery
- Being tested
- Subxiphoid uniportal VATS, Intercostal uniportal VATS
- Keywords
- Mediastinal Neoplasms, Pain, Quality of life
- Medical subject headings
- Mediastinal Neoplasms, Thoracic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subxiphoid uniportal VATSProcedure or surgery
Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections
Intercostal uniportal VATSProcedure or surgery
The surgical procedures followed principles of pulmonary resections
| Study group | Role | What they receive |
|---|---|---|
| Subxiphoid uniportal VATS | Experimental | Standard Subxiphoid single-port video assisted mediastinal thymectomy, no use of rib-spreader. Receives: Procedure: Subxiphoid uniportal VATS |
| Intercostal uniportal VATS | Active comparator | Standard Intercostal single-port video assisted mediastinal thymectomy, no use of rib-spreader. Receives: Procedure: Intercostal uniportal VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
Measured: 6 months
Secondary outcomes (1)
Quality of life
the EuroQol 5 Dimensions (EQ5D) and European Organisation for Research and Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30) are used. EQ5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state. QLQ-C30 is a 30-item questionnaire, from which six functional domains of quality of life (physical function, emotional function, cognitive function, social function, and role function), and nine symptom domains (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite, constipation, diarrhoea, and financial difficulties) can be extracted, as well as an overall score.
Measured: 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 May 2018
- Study start4 Apr 2018
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal NeoplasmsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521986
- Sponsor's protocol ID
- leijiang2
- Status last verified
- May 2022
- First submitted
- 30 Apr 2018
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Quality of Life for Patients Undergoing Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03521986
- Acronym / sponsor ID
- leijiang2
- Conditions
- Mediastinal Neoplasms, Thoracic Neoplasm, Thoracic Surgery
- Keywords
- Mediastinal Neoplasms, Pain, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lei JiangUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 11 May 2018 (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.
Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used surgical methods, but there are some deficiencies.Minimally invasive surgery through the subxiphoid approach can achieve a good surgical field of vision. (1) The surgical field is fully exposed. (2) damage to intercostal nerves can be avoided.(3) Operation time, intraoperative blood loss, postoperative Extubation time is similar to VATS. But there is still lack of evidence.
In this study, 50 patients undergoing subxiphoid uniportal VATS and 50 patients undergoing intercostal uniportal VATS were included to evaluate the post-operative pain and quality of life after surgery.
Detailed description
The types of tumors in the medial mediastinal area were different. Thymoma, germ cell tumors, ectopic parathyroid tumors, and lymphoid tumors were in the anterior mediastinum. Bronchial cysts, pericardial cysts, and lymphomas were in the middle mediastinum. The principles of treatment for mediastinal tumor surgery must be both safe and radical. Radical resection is the dominant position in the treatment of mediastinal tumors, including traditional open surgery and thoracoscopic assisted minimally invasive surgery. At present, minimally invasive surgery for mediastinal tumor includes video-assisted thoracoscopic surgery via subxiphoid approach, left or right intercostal approach, trans-cervical approach and "Da Vinci" robotic system. Compared with conventional sternotomy, thoracoscopic assisted minimally invasive mediastinal tumor resection has clearer, multi-angle surgical vision, less trauma, less intraoperative blood loss, early postoperative extubation, and short postoperative hospital stay, postoperative recovery faster, less pain, fewer complications and meet the beauty needs and so on. Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used surgical methods, but there are some deficiencies.
Minimally invasive surgery through the subxiphoid approach can achieve a good surgical field of vision. Compared with the traditional transcostal VATS medial mediastinal tumor resection, the subxiphoid thoracoscopic surgery had obvious advantages: (1) The surgical field is fully exposed. For patients with myasthenia gravis, it is particularly necessary to clean bilateral mediastinal adipose tissue; (2) Without intercostal surgery, damage to intercostal nerves can be avoided, postoperative pain can be reduced, and quality of life can be improved; (3) Operation time, intraoperative blood loss, postoperative Extubation time is similar to VATS. Disadvantages are as follows: (1) If there is a large hemorrhage during surgery, an emergency transfer to open the chest is required. The injury is greater and the operation is more troublesome; (2) Anterior septal space is Smaller, surgical instruments are more likely to interfere with each other. But there is still lack of evidence to prove which is better.
In this study, 100 patients with anterial and middle mediastinal tumors were selected as study subjects. 50 patients undergoing subxiphoid uniportal VATS were included in the observation group, and 50 patients undergoing intercostal uniportal VATS were included in the control group. The operation time, incision length, intraoperative blood loss, postoperative drainage time, postoperative drainage, hospitalization and hospitalization costs of the 2 groups would be observed. The clinical efficacy and incidence of complications were compared between the 2 groups. After six months of follow-up, postoperative pain and postoperative quality of life were observed in the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subxiphoid uniportal VATS | Experimental | Procedure: Subxiphoid uniportal VATSStandard Subxiphoid single-port video assisted mediastinal thymectomy, no use of rib-spreader. |
| Intercostal uniportal VATS | Active comparator | Procedure: Intercostal uniportal VATSStandard Intercostal single-port video assisted mediastinal thymectomy, no use of rib-spreader. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of anterial and middle mediastinal tumors ;
- Normal heart function, pulmonary function FEV1 %> 60% PaO2> 80 mmHg
- BMI<30
Key exclusion criteria (6 listed)
- enlargement of lymph nodes was seen in the clinical CT readings.
- Preoperative chronic pain or chronic opioid analgesics
- Preoperative check for mental disorders such as hyper-anxiety
- History of previous thoracic surgery
- Patients with thoracic deformity (eg, funnel chest and chicken breast)
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 |
|---|---|---|
| Subxiphoid uniportal VATSPatients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections | Procedure or surgery | Subxiphoid uniportal VATS |
| Intercostal uniportal VATSThe surgical procedures followed principles of pulmonary resections | Procedure or surgery | Intercostal uniportal VATS |
Primary outcome
Postoperative pain
Time frame: 6 months
visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
1 secondary outcome
Quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Subxiphoid uniportal VATS and Intercostal uniportal VATS in people with Mediastinal Neoplasms and Thoracic Neoplasm, run by Lei Jiang 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lei jiang, doctor (86 13917912348, jiangleiem@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2022.