Surgical Technique for Lung Cancer

Recruiting at 3 trial locations

Overseen By Tyler Grenda, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Previous cancer, Blood transfusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if changing the order of cutting blood vessels during lung surgery can reduce cancer cell spread in patients with stage I-III non-small cell lung cancer. It compares two techniques: starting with the vein or with the artery (Pulmonary Artery-First Surgical Technique). Researchers hope that starting with the vein might lower the risk of spreading cancer cells during surgery, potentially improving survival. This trial suits individuals diagnosed with early-stage lung cancer who plan to undergo lung surgery as part of their treatment. As an unphased trial, it offers patients the chance to contribute to innovative surgical techniques that could enhance future cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical techniques are safe for lung cancer patients?

Research shows that both the pulmonary vein-first and pulmonary artery-first surgical techniques are generally safe for lung surgery patients. Studies have found that surgeons can perform the pulmonary artery-first method without causing major bleeding or blood clots, which are serious concerns during surgery. Specifically, one study found that avoiding heparin (a blood thinner) during pulmonary artery reconstruction prevented complications like excessive bleeding in over 98% of patients.

Some evidence suggests that the vein-first technique might offer better long-term outcomes by possibly reducing tumor spread. However, both techniques are standard procedures in lung cancer surgery and have been safely used in many patients. Reports of negative effects are low, indicating that most people tolerate these surgical methods well.

Overall, these findings suggest that patients can feel confident about the safety of these surgical techniques when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the surgical techniques being tested for lung cancer because they aim to improve surgical precision and patient outcomes. The pulmonary artery-first approach could potentially reduce the risk of cancer cells spreading during surgery by minimizing blood flow disruptions. On the other hand, the pulmonary vein-first approach might offer benefits in terms of reducing surgical complexity. By comparing these two techniques, researchers hope to identify which method offers better safety and effectiveness, ultimately enhancing surgical outcomes for lung cancer patients.

What evidence suggests that these surgical techniques are effective for lung cancer?

This trial will compare two surgical techniques for treating non-small cell lung cancer. Research has shown that the pulmonary artery-first surgical technique, which participants in Group II will undergo, is effective, offering a 5-year survival rate of about 50%. One study found that patients with early-stage lung cancer who had artery-first surgery experienced better 4-year survival rates. This technique also helps avoid major complications like excessive bleeding and the need for more extensive surgery. Overall, evidence supports it as a reliable surgical option. Meanwhile, participants in Group I will undergo the pulmonary vein-first approach, which the trial will evaluate for effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Tyler Grenda, MD

Principal Investigator

TJU

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage (I-III) non-small cell lung cancer, who are scheduled for routine lung surgery. It's not open to those with a recent cancer diagnosis within the last 5 years (with some exceptions), or patients who've had preoperative chemo, immunotherapy, radiation, or perioperative blood transfusions.

Inclusion Criteria

I am 18 or older with early-stage non-small cell lung cancer.

I am scheduled for a lung surgery to remove part of my lung.

Exclusion Criteria

I have received a blood transfusion around the time of surgery.

I have received chemotherapy, immunotherapy, or radiation before surgery.

I haven't had cancer in the last 5 years, except for certain types that didn't need treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo either pulmonary vein first or pulmonary artery first surgical procedure

1 day

1 visit (in-person)

Immediate Postoperative Follow-up

Blood samples are taken to determine ctDNA levels at postoperative day 2 and day 14

2 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for disease-free survival and overall survival

Up to 5 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Artery-First Surgical Technique

Trial Overview The study compares two surgical techniques used during lung resection surgery: pulmonary vein-first and pulmonary artery-first. The goal is to see which method better reduces circulating tumor DNA levels, potentially affecting long-term survival.

How Is the Trial Designed?

Group I: Group I (pulmonary vein first approach procedure) Active Control 1 Intervention

Patients undergo pulmonary vein first approach surgical procedure on day of surgery.

Group II: Group II (pulmonary artery first surgical procedure) Active Control 1 Intervention

Patients undergo pulmonary artery first approach surgical procedure on day of surgery.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7328936/

Vein-first vs artery-first surgical technique for lobectomy of non ... This study will be the first meta-analysis to compare the efficacy of the vein-first and artery-first surgical technique of lobectomy for patients diagnosed ...

2. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(15)00801-2/fulltext

Surgical Techniques and Long-Term Results of Pulmonary ... Pulmonary complications occurred in 33 patients, cardiac in 28, and air leaks in 17. Overall 5-year and 10-year survival was 50% and 39%, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022522322000873

Pulmonary artery reconstruction for non–small cell lung ... Pulmonary artery reconstruction without heparinization avoided pneumonectomy in more than 98% of the patients, with a low risk of bleeding and thrombosis.

4. cardiothoracicsurgery.biomedcentral.com cardiothoracicsurgery.biomedcentral.com/articles/10.1186/1749-8090-8-219

Surgical techniques and results of the pulmonary artery ... The estimated 5-year survival rate was 50.2%, which is consistent with that reported for standard resection [11]. The results from the present ...

5. jto.org jto.org/article/S1556-0864(15)34916-9/pdf

Pulmonary artery reconstruction for lung cancer Results: In pooled analysis of 848 patients in three trials (figure 1),. 4-year survival was superior in patients undergoing resection with stage. I to IIIA ...

6. cardiothoracicsurgery.biomedcentral.com cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-021-01658-w

Vein-first versus artery-first ligation procedure for lung cancer ... Vein-first ligation in lung cancer surgery may be associated with improved survival of the patients, which might be ascribed to potentially lower risk of tumor ...

7. jtcvs.org jtcvs.org/article/S0022-5223(22)01026-1/fulltext

Clinical and financial outcomes of pulmonary resection for ... Hospital safety-net status was associated with greater odds of perioperative complications and greater health care expenditure.