John Murphy, MDLinx | July 11, 2016
A new clinical trial in humans could revolutionize lung cancer, making it safer, much less invasive, and possibly less costly than the conventional open-chest method, according to thoracic surgery researchers at the University of Montreal Hospital Research Centre (CRCHUM), in Montreal, Quebec, Canada.
This new Phase II clinical trial is primarily testing the safety and effectiveness of a surgical device—new to thoracic surgery—that uses ultrasonic energy to seal small branches of pulmonary arteries during video-assisted thoracoscopic (VATS) lobectomy. The trial is currently recruiting a total of 150 participants in the US, Canada, and Europe.
“I think this technique could completely change the way we perform surgery for lung cancer, which is the deadliest form of cancer in North America,” said lead investigator Moishe Liberman, MD, PhD, a thoracic surgeon and researcher at CRCHUM and an Associate Professor of Surgery at the University of Montreal.
Currently, the most common surgery for lung cancer—pulmonary lobectomy—is typically performed by thoracotomy. But this highly invasive and risky procedure leaves a long scar, and recovery is painful and lengthy (up to 6 months), Dr. Liberman noted.
Another procedure is the less invasive VATS technique, in which the thoracic surgeon makes only three small port incisions in the chest—two for the instruments and one for the video camera that shows the surgeon where to guide the instruments.
“The technique is beneficial, but it is not widely practiced, because the risk of major bleeding makes it difficult to control,” Dr. Liberman said. The current VATS technique is used in only about 15% of lung cancer surgeries, he noted.
“Pulmonary arteries are thin and fragile,” Dr. Liberman explained. “If there is bleeding during open surgery, then it’s easy: we stitch it up and that’s it. But when we work with a camera and there is bleeding and we can’t see through the lens, the patient can die quickly, because the pulmonary artery is connected directly to the heart.”
This danger is the main reason why thoracic surgeons have been reluctant to adopt the VATS technique. Surgeons currently use a vascular endostapler to close up the pulmonary arteries, but endostaplers can also cause iatrogenic damage to these arteries, especially the short, small branches.
That’s where this clinical trial comes in. Dr. Liberman and colleagues are investigating an instrument that uses ultrasonic energy to tightly seal these vessels during the VATS procedure, with the hope that it eliminates unexpected bleeding.
The investigators already tested the ultrasonic device—Ethicon’s Harmonic Ace® +7 Shears—in phase I and phase II trials in animals. In one recent in vivo study in which researchers used the VATS technique with the ultrasound instrument in 30 healthy dogs, none of the animals had a postoperative hemorrhagic complication and all dogs survived for the 30-day post-op study period.
Dr. Liberman hopes this new surgical approach, if validated, will also save and improve human lives. “I think it will decrease the risk of bleeding and reduce postoperative pain. Patients will be able to resume their normal lives more quickly,” he said.
Click here to watch a video of Dr. Liberman performing a VATS lobectomy using the ultrasonic shears.
This study is being funded by the University of Montreal Hospital Centre and Johnson & Johnson. Ethicon, the developer of the device, is a division of Johnson & Johnson.