Video-assisted Thoracoscopic SurgeryICVATRNCT04663191
Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival
An observational study of Video-assisted Thoracoscopic Surgery and Lung Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades [either video-assisted thoracoscopic surgery (VATS) or robotic-assisted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery, Lung Cancer, Lobectomy
- What is being tested?
- anatomical resection
- Type of treatment
- Surgery or procedure
- How many people
- 843 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2020to 3 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.
Who may be able to join
- All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.
Who cannot join
- patients with non-anatomical pulmonary resection (wedge resection)
- patients with a histology other than NSCLC (benign or metastatic from another primitive cancer), stage IV NSCLC disease,
- patients with multiple primary NSCLC (synchronous or metachronous)
- patients with incomplete resection (R+)
- patient for whom a VATS approach was never considered
Trial locations and contacts
1 site in 1 country.
About this study
Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades [either video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS)], as they provide the patient with better outcomes than open thoracotomy. Minimally invasive VATS lobectomy for a standard case is generally a straightforward procedure for a well-trained surgical team, although concomitant preoperative pathologies or intraoperative findings/adverse events may result in technical difficulties, leading to intraoperative conversion, commonly by thoracotomy.
The investigators aimed to assess long-term outcomes in a consecutive cohort of patients treated by anatomical pulmonary resection either using VATS, VATS requiring intraoperative conversion to thoracotomy, or upfront open thoracotomy for lung-cancer surgery.
- Conditions
- Video-assisted Thoracoscopic Surgery, Lung Cancer, Lobectomy, Survival, Surgery
- Being tested
- anatomical resection
- Keywords
- video-assisted thoracoscopic surgery, lung-cancer surgery, intraoperative conversion to open surgery, lobectomy, survival
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anatomical resectionProcedure or surgery
Anatomical resection with systematic lymph-node dissection
| Study group | Role | What they receive |
|---|---|---|
| Full VATS | Not described Receives: Procedure: anatomical resection | |
| VATS with conversion | Not described Receives: Procedure: anatomical resection | |
| Thoracotomy upfront | Not described Receives: Procedure: anatomical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival during the follow-up period after surgery
Measured: from day of surgery up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start2 Jan 2020
- Primary completion2 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663191
- Sponsor's protocol ID
- T38
- Acronym
- ICVATR
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival
- ClinicalTrials.gov ID
- NCT04663191
- Acronym / sponsor ID
- ICVATR / T38
- Conditions
- Video-assisted Thoracoscopic Surgery, Lung Cancer, Lobectomy, Survival, Surgery
- Keywords
- video-assisted thoracoscopic surgery, lung-cancer surgery, intraoperative conversion to open surgery, lobectomy, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 10 Dec 2020 (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.
Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades [either video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS)], as they provide the patient with better outcomes than open thoracotomy. Minimally invasive VATS lobectomy for a standard case is generally a straightforward procedure for a well-trained surgical team, although concomitant preoperative pathologies or intraoperative findings/adverse events may result in technical difficulties, leading to intraoperative conversion, commonly by thoracotomy.
The investigators aimed to assess long-term outcomes in a consecutive cohort of patients treated by anatomical pulmonary resection either using VATS, VATS requiring intraoperative conversion to thoracotomy, or upfront open thoracotomy for lung-cancer surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full VATS | – | Procedure: anatomical resection |
| VATS with conversion | – | Procedure: anatomical resection |
| Thoracotomy upfront | – | Procedure: anatomical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.
Key inclusion criteria (1 listed)
- All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.
Key exclusion criteria (5 listed)
- patients with non-anatomical pulmonary resection (wedge resection)
- patients with a histology other than NSCLC (benign or metastatic from another primitive cancer), stage IV NSCLC disease,
- patients with multiple primary NSCLC (synchronous or metachronous)
- patients with incomplete resection (R+)
- patient for whom a VATS approach was never considered
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 |
|---|---|---|
| anatomical resectionAnatomical resection with systematic lymph-node dissection | Procedure or surgery | Full VATS, Thoracotomy upfront, VATS with conversion |
Primary outcome
Overall survival during the follow-up period after surgery
Time frame: from day of surgery up to 7 years
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 16 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Video-assisted Thoracoscopic Surgery
Not yet recruiting
TBLC vs NIVATS in Interstitial Lung Disease
Interstitial Lung Diseases (ILD)
Not yet recruiting
Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection
Thoracic Neoplasms
Recruiting
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah
Pain, Postoperative Pain
Recruiting
Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia
Postoperative Pain, Thoracic Surgery
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Video-assisted Thoracoscopic Surgery and Lung Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 1 inclusion and 5 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 16 Dec 2020. 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 France. 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?
Overall survival during the follow-up period after surgery (time frame: from day of surgery up to 7 years). 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 16 Dec 2020.