Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial
Autor: | Miguel A. Cuesta, Suzanne S. Gisbertz, Luigi Bonavina, Donald L. van der Peet, Josep Garcia, Camiel Rosman, Freek Daams, Nicole van der Wielen, Jennifer Straatman, Mark I. van Berge Henegouwen |
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Přispěvatelé: | CCA - Cancer Treatment and Quality of Life, Surgery, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism |
Rok vydání: | 2017 |
Předmět: |
Male
medicine.medical_specialty Esophageal Neoplasms medicine.medical_treatment Postoperative recovery Disease-Free Survival law.invention Resection Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] 03 medical and health sciences Postoperative Complications 0302 clinical medicine Time trial Randomized controlled trial Quality of life law medicine Humans Patient Reported Outcome Measures Neoadjuvant therapy business.industry Length of Stay Middle Aged Esophageal cancer medicine.disease Neoadjuvant Therapy Surgery Esophagectomy Editorial 030220 oncology & carcinogenesis Quality of Life Female Laparoscopy 030211 gastroenterology & hepatology business Follow-Up Studies |
Zdroj: | Annals of Surgery, 266, 232-236 Annals of Surgery, 266, 2, pp. 232-236 Annals of surgery, 266(2), 232-236. Lippincott Williams and Wilkins |
ISSN: | 0003-4932 |
DOI: | 10.1097/sla.0000000000002171 |
Popis: | Contains fulltext : 175624.pdf (Publisher’s version ) (Closed access) OBJECTIVE: 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. BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. |
Databáze: | OpenAIRE |
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