All authors meet the criteria for authorship as set forth in the Consensus Statement on Journal Authorship. Potential conflicts of interest or financial ties are stated further below.
The minimally invasive esophagectomy (MIE) for esophageal cancer was introduced assuming a reduction of morbidity and operation time. After implementation of MIE at our institution, a randomized controlled trial was designed.
This is a prospective randomized controlled study comparing open (OE) and laparoscopic gastric tube (MIE) formation in Ivor Lewis esophagectomy. Primary endpoints were morbidity and 30-day mortality. Secondary endpoints included the duration of intensive care unit stay, length of hospital stay, operative time as well as relapse-free and overall survival.
Twenty patients (76.9%) were male, median age was 63 years (40–77). Median operation time was 290 (215–385) minutes in OE and 292.5 (200–450) minutes in MIE group, p = 0.421. Major complications occurred in 4 (33.3%) patients in the OE group and in 6 (35.7%) patients in the MIE group. Anastomotic leakage was seen in 2 (16.6%) and 3 (21.4%) patients, respectively (OR 1.364; CI = 0.188–9.912; p = 0.759). Due to an alarming number of consecutive anastomotic leakages, the trial was stopped after inclusion of 26 patients. Median follow-up was 41.5 (1–62.6) months. 5‑year survival rate was 50%. Thirty-eight percent developed recurrence of disease in the study period. There was no significant difference in overall and relapse-free survival regarding the type of surgery.
This study shows that hybrid MIE is a feasible alternative for esophageal resection. Morbidity, mortality, and oncological long-term results were equal in both groups, but the interpretation has to be done carefully due to premature termination of the trial. Interrupting a trial because of patient benefit should not be a reason to discard results but rather to improve technical aspects and strive for novel studies.
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Randomizer for Clinical Trials 1.8.1 https://www.meduniwien.ac.at/randomizer/web/about.php. Jan 1st 2007 until Dec 31st 2017
Schwameis K, Ba-Ssalamah A, Wrba F, Birner P, Prager G, Hejna M, et al. The implementation of minimally-invasive esophagectomy does not impact short-term outcome in a high-volume center. Anticancer Res. 2013;33:2085–91. PubMed
Mariette C, Meunier B, Pezet D, Dalban C, Collet D, Thomas P‑A, et al. Hybrid minimally invasive versus open oesophagectomy for patients with oesophgeal cancer: a multicenter, open-label, randomized phase III controlled trial, the MIRO trial. J Clin Oncol. 2015;33:5. CrossRef
Morbidity in open versus minimally invasive hybrid esophagectomy (MIOMIE)
Long-term results of a randomized controlled clinical study
MD Matthias Paireder
MD Reza Asari
MD Ivan Kristo
MD Erwin Rieder
MD Johannes Zacherl
MD Barbara Kabon
MD Edith Fleischmann
MD, FACS Sebastian F. Schoppmann
- Springer Vienna
Acta Chirurgica Austriaca
Print ISSN: 1682-8631
Elektronische ISSN: 1682-4016
Neu im Fachgebiet Chirurgie
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