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07.08.2018 | original article | Ausgabe 6/2018 Open Access

European Surgery 6/2018

Morbidity in open versus minimally invasive hybrid esophagectomy (MIOMIE)

Long-term results of a randomized controlled clinical study

Zeitschrift:
European Surgery > Ausgabe 6/2018
Autoren:
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
Wichtige Hinweise
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.

Summary

Background

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.

Methods

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.

Results

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.

Conclusion

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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