Lung NeoplasmsNCT02031809
Multicentric Study VATS Major Introperative Complications
An observational study of Lung Neoplasms, run by University Hospital, Gasthuisberg at 9 sites in 9 countries.
Trial summary
This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Neoplasms
- How many people
- 3,076 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Jan 2014to Oct 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients intended to undergo a vats anatomical resection
Who may be able to join
- Patients that did undergo resection for oncologic reasons
Who cannot join
- Patients that did not undergo resection for oncologic reasons, such as pleural metastasis, irresectable disease.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
Austria1 site
Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital
Innsbruck
France1 site
Thoracic Department, Institut Mutualiste Montsouris
Paris, F-75014
Poland1 site
Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery
Poznan
About this study
Official title: Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS
This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion
Read the detailed description
Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure results in at least equal oncologic results and survival, perhaps better.
Most series do not publish their early experience. They are retrospective and report on lobectomies and segmentectomies, excluding the live-saving pneumonectomies. They are potentially ignoring the intention-to-treat principle, excluding conversions.
Based on scarce existing literature and conference worst-case presentations a pattern of the most common intraoperative major complications can be drawn In Europe, a large percentage of high-volume-centres have now successfully implemented a vats lobectomy program. In this era with low-volume-centres switching into vats anatomical resections, it is important to focus on potentially life-threatening complications. To be aware of potential hazards is the best way to avoid them.
- Conditions
- Lung Neoplasms
- Keywords
- Thoracic Surgery, Video-Assisted
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No additional unplanned major surgery | uneventfull intra-operative and postoperative course | |
| Additional unplanned major surgery | Additional per-operative or post-operative unplanned major surgery such as unforeseen pneumonectomy, bilobectomy, lobectomy or additional segmentectomy, repair of major vessels or bronchi, bronchopleural fistula, unplanned surgery to other organs, within 30 days after the primary surgery. These do not include: * Conversions without additional unplanned major surgery or suddne blood loss less than 500cc * Conversions or additional resection for unforeseen oncologic reasons. * Plasty, repair or sleeve resection of vessels after deliberate resection or transection for oncologic reasons |
What is being measured
The primary outcome is the main question the study is designed to answer.
additional unplanned major surgery
the percentage of major complications that resulted in additional unplanned major surgery during vats anatomical resection or at revision within 30 days.
Measured: during vats anatomical resection or at revision within 30 days
Secondary outcomes (1)
number of conversions to open surgery
The number of VATS procedures that need conversion to open surgery because of major complications or unplanned major surgery
Measured: during VATS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Moons, University Hospital, Gasthuisberg
- Investigators
- Herbert Dacaluwé, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenDominique Gossot, MD, Principal investigator, Thoracic Department, Institut Mutualiste Montsouris, 42 Bd Jourdan, F-75014 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031809
- Sponsor's protocol ID
- MC_VATS complic
- Status last verified
- Sep 2019
- First submitted
- 7 Jan 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS
- ClinicalTrials.gov ID
- NCT02031809
- Acronym / sponsor ID
- MC_VATS complic
- Conditions
- Lung Neoplasms
- Keywords
- Thoracic Surgery, Video-Assisted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,076 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- 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.
This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion
Detailed description
Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure results in at least equal oncologic results and survival, perhaps better.
Most series do not publish their early experience. They are retrospective and report on lobectomies and segmentectomies, excluding the live-saving pneumonectomies. They are potentially ignoring the intention-to-treat principle, excluding conversions.
Based on scarce existing literature and conference worst-case presentations a pattern of the most common intraoperative major complications can be drawn In Europe, a large percentage of high-volume-centres have now successfully implemented a vats lobectomy program. In this era with low-volume-centres switching into vats anatomical resections, it is important to focus on potentially life-threatening complications. To be aware of potential hazards is the best way to avoid them.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No additional unplanned major surgery | – | –uneventfull intra-operative and postoperative course |
| Additional unplanned major surgery | – | –Additional per-operative or post-operative unplanned major surgery such as unforeseen pneumonectomy, bilobectomy, lobectomy or additional segmentectomy, repair of major vessels or bronchi, bronchopleural fistula, unplanned surgery to other organs, within 30 days after the primary surgery. These do not include: * Conversions without additional unplanned major surgery or suddne blood loss less than 500cc * Conversions or additional resection for unforeseen oncologic reasons. * Plasty, repair or sleeve resection of vessels after deliberate resection or transection for oncologic reasons |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients intended to undergo a vats anatomical resection
Key inclusion criteria (1 listed)
- Patients that did undergo resection for oncologic reasons
Key exclusion criteria (1 listed)
- Patients that did not undergo resection for oncologic reasons, such as pleural metastasis, irresectable disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
additional unplanned major surgery
Time frame: during vats anatomical resection or at revision within 30 days
the percentage of major complications that resulted in additional unplanned major surgery during vats anatomical resection or at revision within 30 days.
1 secondary outcome
number of conversions to open surgery
Time frame: during VATS procedure
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 26 Sep 2019.
Related trials for Lung Neoplasms
Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
RecruitingPhase 3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Carcinoma, Non-Small-Cell Lung
Not yet recruitingPhase 1/2
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma
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.
Herbert Dacaluwé, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Dominique Gossot, MD principal investigator
Thoracic Department, Institut Mutualiste Montsouris, 42 Bd Jourdan, F-75014 Paris, France
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by University Hospital, Gasthuisberg at 9 sites in 9 countries.
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 1 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria, Denmark, France, Germany, Italy and 4 more countries. 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?
additional unplanned major surgery (time frame: during vats anatomical resection or at revision within 30 days). 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 26 Sep 2019.