Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial

• Published in: Annals of surgery Vol. 266; no. 2; p. 232
• Main Authors: Straatman, Jennifer, van der Wielen, Nicole, Cuesta, Miguel A, Daams, Freek, Roig Garcia, Josep, Bonavina, Luigi, Rosman, Camiel, van Berge Henegouwen, Mark I, Gisbertz, Suzanne S, van der Peet, Donald L
• Format: Journal Article
• Language: English
• Published: United States 01.08.2017
• Subjects: Disease-Free Survival; Esophageal Neoplasms - mortality; Esophageal Neoplasms - surgery; Esophagectomy - adverse effects; Esophagectomy - methods; Female; Follow-Up Studies; Humans; Laparoscopy - adverse effects; Laparoscopy - methods; Length of Stay; Male; Middle Aged; Neoadjuvant Therapy; Patient Reported Outcome Measures; Postoperative Complications; Quality of Life
• ISSN: 1528-1140
• DOI: 10.1097/SLA.0000000000002171

The aim of this study was to investigate 3-year survival following a randomized controlled trial comparing minimally invasive with open esophagectomy in patients with esophageal cancer. Research on minimally invasive esophagectomy (MIE) has shown faster postoperative recovery and a marked decrease in pulmonary complications. Debate is ongoing as to whether the procedure is equivalent to open resection regarding oncologic outcomes. The study is a follow-up study of the TIME-trial (traditional invasive vs minimally invasive esophagectomy, a multicenter, randomized trial). Between June 2009 and March 2011, patients with a resectable intrathoracic esophageal carcinoma, including the gastroesophageal junction tumors (Siewert I), were randomized between open and MI esophagectomy with curative intent. Primary outcome was 3-year disease-free survival. Secondary outcomes include overall survival, lymph node yield, short-term morbidity, mortality, complications, radicality, local recurrence, and metastasis. Analysis was by intention-to-treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Both trial protocol and short-term results have been published previously. One hundred fifteen patients were included from 5 European hospitals and randomly assigned to open (n = 56) or MI esophagectomy (n = 59). Combined overall 3-year survival was 40.4% (SD 7.7%) in the open group versus 50.5% (SD 8%) in the minimally invasive group (P = 0.207). The hazard ratio (HR) is 0.883 (0.540 to 1.441) for MIE compared with open surgery. Disease-free 3-year survival was 35.9% (SD 6.8%) in the open versus 40.2% (SD 6.9%) in the MI group [HR 0.691 (0.389 to 1.239). The study presented here depicted no differences in disease-free and overall 3-year survival for open and MI esophagectomy. These results, together with short-term results, further support the use of minimally invasive surgical techniques in the treatment of esophageal cancer.