Lung CancerVALUENCT05583916
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
A study testing Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung in people with Lung Cancer and Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Phase I to evaluate the safety and feasibility of same-day discharge in selected participants undergoing minimally-invasive lung surgery and who receive an enhanced recovery pathway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Surgery
- What is being tested?
- Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2022to Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed or verbal informed consent by participant
- Male and female adults, age 18 and above
- Clinical stage I-II lung cancer (suspected, proven, unproven), or secondary pulmonary malignancy
- BMI < 35
- ECOG 0-1
- Eligible for surgery and lung cancer resection (FEV1 > 60%, DLCO > 60%)
- Elective VATS anatomic resection (segmentectomy or lobectomy), or wedge resection
- Capable caregiver for discharge home
Who cannot join
- Clinical stage III lung cancer
- Surgery requiring pneumonectomy
- Neoadjuvant therapy
- Active pregnancy or breastfeeding
- History of chronic pain syndromes
- History of chronic opioid use
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- Concomitant major surgery indicated with current admission to hospital
- Anticipated intraoperative complication including conversion to thoracotomy, major bleeding requiring blood transfusion, extensive adhesiolysis, injury to mediastinal structures, airway injury, nerve injury (phrenic, recurrent)
- Need for epidural or patient-controlled intravenous analgesia
- Need for urinary catheter
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Jonathan Spicer, MD PhD
About this study
Official title: Phase I Safety and Feasibility Pilot Study of Same-Day Discharge After Video-Assisted Thoracoscopic Surgery (VATS) Anatomical Lung or Wedge Resection (VALUE Trial)
Phase I to evaluate the safety and feasibility of same-day discharge in selected participants undergoing minimally-invasive lung surgery and who receive an enhanced recovery pathway.
- Conditions
- Lung Cancer, Surgery
- Being tested
- Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung
- Keywords
- Same Day Discharge, Video-Assisted Thoracoscopic Surgery (VATS), Minimally Invasive Surgery, Enhanced Recovery Pathway
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) LungProcedure or surgery
All patients will be scheduled to surgery at the start of the day and will be discharged within the same day as the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Patients | Other | Patients with stage I or II primary lung cancer or pulmonary metastasis scheduled to undergo surgery. Receives: Procedure: Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Rate
Measured: 30 days post surgery
Same Day Discharge Rate
Measured: Throughout the trial, from start until completion of surgery for all the patients, up to 12 months.
Readmission Rate
Measured: 30 days post surgery
Rate of presentation to the emergency room after surgery
Measured: 30 days post surgery
Secondary outcomes (6)
Edmonton Symptom Assessment Scale (ESAS)
Rating pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath, on a scale of 1 to 10. Higher scores indicate more serious symptoms.
Measured: 30 days post surgery
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Rating questions regarding physical, social/family, emotion and function well-being as well as general questions regarding medical health, on a scale of 0-4 (from 'Not at all' to 'Very much').
Measured: 30 days post surgery
Duration of indwelling chest tube catheter
Measured: 30 days post surgery or until the chest tube is removed (whichever comes last, assessed until 90 days post surgery)
Rate of screen failure
Feasibility calculation of the number of patients approached to participate compared to the number of patients consented to the trial.
Measured: From trial start until last patient consented, up to 12 months.
Percent of eligible participants consented
Measured: From trial start until last patient consented, up to 12 months.
Pathway adherence rate
Calculation of the number of participants who stay on the same-day discharge pathway versus number of patients who deviate from the protocol.
Measured: From moment of consent until 1 day post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start7 Sep 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Spicer, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jonathan Spicer, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583916
- Sponsor's protocol ID
- 2021-7318
- Acronym
- VALUE
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Walsh LC, Rokah M, Seitlinger J, Gallina FT, Huynh C, Gold MS, Sengupta A, Nicholls-Wallace T, Cronin E, Dehghani M, Rayes R, Mulder D, Sirois C, Rousseau M, Ferri L, Cools-Lartigue J, Costescu F, Najmeh S, Spicer JD. VALUE Trial: Phase 1 safety and feasibility study of same-day discharge after video-assisted thoracoscopic surgery lung resection. J Thorac Cardiovasc Surg. 2026 Jan;171(1):33-39. doi: 10.1016/j.jtcvs.2025.07.040. Epub 2025 Aug 6.
PubMed 40780316
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Feasibility Pilot Study of Same-Day Discharge After Video-Assisted Thoracoscopic Surgery (VATS) Anatomical Lung or Wedge Resection (VALUE Trial)
- ClinicalTrials.gov ID
- NCT05583916
- Acronym / sponsor ID
- VALUE / 2021-7318
- Conditions
- Lung Cancer, Surgery
- Keywords
- Same Day Discharge, Video-Assisted Thoracoscopic Surgery (VATS), Minimally Invasive Surgery, Enhanced Recovery Pathway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 Oct 2022 (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.
Phase I to evaluate the safety and feasibility of same-day discharge in selected participants undergoing minimally-invasive lung surgery and who receive an enhanced recovery pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Patients | Other | Procedure: Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) LungPatients with stage I or II primary lung cancer or pulmonary metastasis scheduled to undergo surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed or verbal informed consent by participant
- Male and female adults, age 18 and above
- Clinical stage I-II lung cancer (suspected, proven, unproven), or secondary pulmonary malignancy
- BMI < 35
- ECOG 0-1
Key exclusion criteria (10 listed)
- Clinical stage III lung cancer
- Surgery requiring pneumonectomy
- Neoadjuvant therapy
- Active pregnancy or breastfeeding
- History of chronic pain syndromes
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 |
|---|---|---|
| Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) LungAll patients will be scheduled to surgery at the start of the day and will be discharged within the same day as the procedure. | Procedure or surgery | Lung Cancer Patients |
Primary outcome
Adverse Event Rate
Time frame: 30 days post surgery
Same Day Discharge Rate
Time frame: Throughout the trial, from start until completion of surgery for all the patients, up to 12 months.
Readmission Rate
Time frame: 30 days post surgery
Rate of presentation to the emergency room after surgery
Time frame: 30 days post surgery
6 secondary outcomes
Edmonton Symptom Assessment Scale (ESAS)
Time frame: 30 days post surgery
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Time frame: 30 days post surgery
Duration of indwelling chest tube catheter
Time frame: 30 days post surgery or until the chest tube is removed (whichever comes last, assessed until 90 days post surgery)
Rate of screen failure
Time frame: From trial start until last patient consented, up to 12 months.
Percent of eligible participants consented
Time frame: From trial start until last patient consented, up to 12 months.
Pathway adherence rate
Time frame: From moment of consent until 1 day post surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 40780316Walsh LC, Rokah M, Seitlinger J, Gallina FT, Huynh C, Gold MS, Sengupta A, Nicholls-Wallace T, Cronin E, Dehghani M, Rayes R, Mulder D, Sirois C, Rousseau M, Ferri L, Cools-Lartigue J, Costescu F, Najmeh S, Spicer JD. VALUE Trial: Phase 1 safety and feasibility study of same-day discharge after video-assisted thoracoscopic surgery lung resection. J Thorac Cardiovasc Surg. 2026 Jan;171(1):33-39. doi: 10.1016/j.jtcvs.2025.07.040. Epub 2025 Aug 6.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan Spicer, MD, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung in people with Lung Cancer and Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 8 inclusion and 10 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 18 Oct 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Spicer, MD, PhD (514-934-1934 ext. 43050, jonathan.spicer@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Rate (time frame: 30 days post surgery). The study lists 4 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 NCT05583916, 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 18 Oct 2022.