Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer.

Autor: Nilsson K; Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.; Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institute, Stockholm, Sweden., Klevebro F; Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.; Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institute, Stockholm, Sweden., Rouvelas I; Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.; Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institute, Stockholm, Sweden., Lindblad M; Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.; Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institute, Stockholm, Sweden., Szabo E; Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden., Halldestam I; Department of Surgery, University Hospital of Linköping, Linköping, Sweden., Smedh U; Department of Surgery, Sahlgrenska University Hospital, Gothenburg Sweden., Wallner B; Department of Surgical and Perioperative Sciences, Umeå University Hospital, Umeå, Sweden., Johansson J; Department of Surgery, Skåne University Hospital, Lund, Sweden., Johnsen G; Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway., Aahlin EK; Department of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway., Johannessen HO; Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway., Hjortland GO; Department of Oncology, Oslo University Hospital, Oslo, Norway., Bartella I; Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany., Schröder W; Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany., Bruns C; Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany., Nilsson M; Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden.; Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institute, Stockholm, Sweden.
Jazyk: angličtina
Zdroj: Annals of surgery [Ann Surg] 2020 Nov; Vol. 272 (5), pp. 684-689.
DOI: 10.1097/SLA.0000000000004340
Abstrakt: Objective: To investigate if prolonged TTS after completed nCRT improves postoperative outcomes for esophageal and esophagogastric junction cancer.
Summary of Background Data: TTS has traditionally been 4-6 weeks after completed nCRT. However, the optimal timing is not known.
Methods: A multicenter clinical trial was performed with randomized allocation of TTS of 4-6 or 10-12 weeks. The primary endpoint of this sub-study was overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay. The study was registered in Clinicaltrials.gov (NCT02415101).
Results: In total 249 patients were randomized. There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603). There were no statistically significant differences between standard and prolonged TTS regarding anastomotic leak (P = 0.596), conduit necrosis (P = 0.524), chyle leak (P = 0.427), pneumonia (P = 0.548), and respiratory failure (P = 0.723). In the standard TTS arm 5 patients (4.3%) died within 90 days of surgery, compared to 4 patients (3.8%) in the prolonged TTS arm (P = 1.0). Median length of hospital stay was 15 days in the standard TTS arm and 17 days in the prolonged TTS arm (P = 0.234).
Conclusion: The timing of surgery after completed nCRT for carcinoma of the esophagus or esophagogastric junction, is not of major importance with regard to short-term postoperative outcomes.
Databáze: MEDLINE