Klara Nilsson1,2, Fredrik Klevebro1,2, Ioannis Rouvelas1,2, Mats Lindblad1,2, Eva Szabo3, Ingvar Halldestam4, Ulrika Smedh5, Bengt Wallner6, Jan Johansson7, Gjermund Johnsen8, Eirik Kjus Aahlin9, Hans-Olaf Johannessen10, Geir Olav Hjortland11, Isabel Bartella12, Wolfgang Schröder12, Christiane Bruns12, Magnus Nilsson1,2. 1. Department of Upper Abdominal Diseases, Karolinska University Hospital, Stockholm, Sweden. 2. Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institute, Stockholm, Sweden. 3. Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. 4. Department of Surgery, University Hospital of Linköping, Linköping, Sweden. 5. Department of Surgery, Sahlgrenska University Hospital, Gothenburg Sweden. 6. Department of Surgical and Perioperative Sciences, Umeå University Hospital, Umeå, Sweden. 7. Department of Surgery, Skåne University Hospital, Lund, Sweden. 8. Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway. 9. Department of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway. 10. Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway. 11. Department of Oncology, Oslo University Hospital, Oslo, Norway. 12. Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Cologne, Germany.
Abstract
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.
RCT Entities:
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.
Authors: Fiorenzo V Angehrn; Kerstin J Neuschütz; Daniel C Steinemann; Martin Bolli; Lana Fourie; Pauline Becker; Markus von Flüe Journal: Surg Endosc Date: 2022-07-19 Impact factor: 3.453