A Phase 3 interventional study of Subxiphoid uniportal VATS and Intercostal uniportal VATS in Lung Neoplasms, Thoracic Surgery and Carcinoma, Non-Small-Cell Lung, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 3, Interventional, and Treatment
Among 46 studies in Carcinoma, Non-Small-Cell Lung by Shanghai Pulmonary Hospital, Shanghai, China — 31 open to participants now, 34 under way, 3 of them phase 3. Carcinoma, Non-Small-Cell Lung · Shanghai Pulmonary Hospital, Shanghai, China.
Among the 46 studies in Carcinoma, Non-Small-Cell Lung by Shanghai Pulmonary Hospital, Shanghai, China, this one is the 5th largest by enrollment of the 34 interventional ones that give a count, is the only one that started in 2017, is one of 5 in phase 3, and was the 3rd registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →31 of the 46 studies in Carcinoma, Non-Small-Cell Lung by Shanghai Pulmonary Hospital, Shanghai, China are open now, in 1 country. Recruiting first, the newest first:
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
Ages 70+
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
Ages 18+
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
Ages 18+
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
Ages 18+
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 26 · Phase 3 6 · Phase 4 2
First in 2016; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 200 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 69 across the 34 interventional studies, 191 across the 12 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
4 of the studies in Carcinoma, Non-Small-Cell Lung by Shanghai Pulmonary Hospital, Shanghai, China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04772287Phase 3Shanghai Pulmonary Hospital, Shanghai, ChinaAdjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008) | 2026-12-30 |
| NCT07493980Shanghai Pulmonary Hospital, Shanghai, ChinaStudy on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients | 2027-01 |
| NCT07328945Shanghai Pulmonary Hospital, Shanghai, ChinaPatient-derived Tumor-like Cell Cluster Model-based Precision Treatment Strategy on Non-small Cell Lung Cancer | 2027-01 |
| NCT06528847Shanghai Pulmonary Hospital, Shanghai, ChinaAdjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma | 2027-06-30 |
Among the 46 studies in Carcinoma, Non-Small-Cell Lung by Shanghai Pulmonary Hospital, Shanghai, China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
One-thirds of patients underwent video-assisted thorascopic surgery (VATS) still have severe pain.Uniportal lobectomy or segmentectomies emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route for pulmonary lobectomies or segmentectomies.We would like to evaluate the post-operative pain and quality of life between Subxiphoid and Intercostal VATS for Lung Cancer.
Is subxiphoid route VATS surgery better than Intercostal VATS surgery for lung cancer?
Video assisted thoracoscopic surgery for lung cancer (VATS) is less traumatic than traditional open surgery for lung cancer. A novel uniportal VATS technique involving a subxiphoid route for thoracic surgery has been occured. It is reported that subxiphoid route VATS surgery is better than Intercostal VATS surgery in post-operative pain and quality of life, but this has never been documented in a randomized trial. Some surgeons hesitate to use subxiphoid VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world, while Shanghai pulmonary Hospital is one of the best to perform subxiphoid VATS. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year.
The investigators include patients with stage I lung cancer, and randomize between subxiphoid VATS and Intercostal VATS in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 1 time daily and followed 6 months using the VAS-score, life quality is evaluated continuously during the first 6 months using SF-MPQ-2 questionnaires.
200 patients will be asked to participate in each study at shanghai pulmonary Hospital,china in collaboration with surgeons from department of thoracic surgery.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 200 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Elective surgery (surgery planed > 2 days).
Accepts randomization.
Age 18 or above.
Exclusion Criteria:
Any type of chronic pain, requiring daily use of analgetics.
pregnant.
Breast feeding.
to NSAID.
Chemo- and/or radiotherapy in connection to present admission.
Major surgery planned in connection to this admission.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Subxiphoid single-port video assisted thoracic surgery, no use of rib-spreader.
Procedure: Subxiphoid uniportal VATS
Standard Intercostal single-port video assisted thoracic surgery, no use of rib-spreader.
Procedure: Intercostal uniportal VATS
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
The surgical procedures followed principles of pulmonary resections
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 ".
Time frame: 6 months
Quality of life
SF-MPQ-2 questionnaire is used.
Time frame: 6 months
Plan to share: Yes
Ran from Nov 2017 to primary completion in Feb 2020, 27 months.
Of 109 non-industry phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 129. This study's 27 months is below that.
Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
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