A hybrid minimally invasive surgery for esophageal cancer reduced the rate of major complications compared with open surgery, a multicenter randomized trial found.
Among 207 patients randomized to esophagectomy, 36% of those who received the less invasive surgery had major intraoperative or postoperative complications at 30 days versus 64% in the open surgery group (OR 0.31, 95% CI 0.18-0.55, P<0.001), according to Guillaume Piessen, MD, PhD, of Claude Huriez University Hospital in Lille, France, and colleagues.
And the results held up after adjustments for age, sex, American Society of Anesthesiologists risk score, tumor location and histology, margin status, pathologic tumor staging, and other factors (adjusted OR 0.23, 95% CI 0.12-0.44, P<0.001), they reported in the New England Journal of Medicine.
“In this multicenter, randomized, controlled trial, we found that hybrid minimally invasive esophagectomy was associated with a 77% lower risk of major intraoperative and postoperative complications than open esophagectomy,” Piessen and colleagues wrote. “Furthermore, minimally invasive surgery was associated with a 50% lower risk of major pulmonary complications than open surgery.”
At 30 days, major pulmonary complications occurred at a rate of 18% in patients assigned to the Ivor-Lewis two-field abdominal-thoracic esophagectomy compared with 30% of those assigned to transthoracic open esophagectomy. There was one patient death at 30 days in the hybrid group compared with two in the open surgery group, and four and six at 90 days, respectively.
“Overall survival and disease-free survival were at least as good with minimally invasive surgery as with the open procedure,” the authors wrote.
At 3 years, the rate of disease-free survival was 57% with the hybrid surgery versus 48% with open surgery, and overall survival was 67% and 55%, respectively — the study was not powered to detect differences in survival.
“It’s interesting that when you look at the various complications, they’re all the same with the exception of the pulmonary complications,” Nasser Altorki, MD, chief of thoracic surgery at NewYork-Presbyterian and Weill Cornell Medicine in New York City, told MedPage Today,
Altorki, who was not involved in the study, noted that this appeared to be driven by a reduction in atelectasis, an accumulation of mucus and areas of collapse in the lung, that requires broncoscopy.
He also added that while in lung cancer minimally invasive techniques have cut hospital stays down from 7 to 3 days at his institution, this reduction has not been achieved for patients with esophageal cancer undergoing esophagectomy.
“In the more complicated cases like an esophagectomy, the length of stay remains unchanged,” said Altorki. Median length of hospital stay was 14 days for each arm in the current study. “I think people just see that there is a benefit to having incisions that hurt less and allow earlier mobility of the patients.”
The current findings join those from the TIME-trial, which used a totally minimally invasive procedure as the only two randomized trials to compare open surgery esophagectomy with a minimally invasive procedure for esophageal cancer.
From 2009 to 2012, researchers from the Fédération de Recherche en Chirurgie and French Eso-Gastric Tumors Working Group randomized 207 patients 1:1 to either transthoracic open esophagectomy or the Ivor-Lewis procedure — a hybrid minimally invasive esophagectomy comprised of a two-field abdominal-thoracic operation with laparoscopic gastric mobilization and open right thoracotomy.
Eligible patients were adults with resectable stage I-III squamous-cell carcinoma or adenocarcinoma in the middle or lower third of the esophagus with N0-2 disease and no metastases. Patients needed to have a World Health Organization (WHO) performance status score ≤2. Baseline characteristics were similar between the two groups. In all there were 312 serious adverse events in 110 patients.
Altorki said that at his institution they’ve been using less invasive techniques for years in this setting, and have gravitated from a fully minimally invasive surgery to a hybrid technique that reverses what was done in the current study, feeling that the major morbidity is from the thoracotomy.
“We avoid the 8- to 10-inch chest incision which is really, in my personal opinion, the one that drives most of the complications, the pulmonary complications, and then do an open belly approach,” he explained.
The study was funded by the French National Cancer Institute.
Piessen and co-authors disclosed no relevant relationships with industry.