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

Nilsson, Klara ; Klevebro, Fredrik ; Rouvelas, Ioannis ; Lindblad, Mats ; Szabo, Eva ; Halldestam, Ingvar ; Smedh, Ulrika LU ; Wallner, Bengt ; Johansson, Jan LU and Johnsen, Gjermund , et al. (2020) In Annals of Surgery 272(5). p.684-689
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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
in
Annals of Surgery
volume
272
issue
5
pages
6 pages
publisher
Lippincott Williams & Wilkins
external identifiers
  • pmid:32833767
  • scopus:85092943866
ISSN
1528-1140
DOI
10.1097/SLA.0000000000004340
language
English
LU publication?
no
id
175d02f9-2a64-4e68-a91c-c61b68b54b35
date added to LUP
2020-11-05 14:46:05
date last changed
2024-04-17 18:01:18
@article{175d02f9-2a64-4e68-a91c-c61b68b54b35,
  abstract     = {{<p>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.</p>}},
  author       = {{Nilsson, Klara and Klevebro, Fredrik and Rouvelas, Ioannis and Lindblad, Mats and Szabo, Eva and Halldestam, Ingvar and Smedh, Ulrika and Wallner, Bengt and Johansson, Jan and Johnsen, Gjermund and Aahlin, Eirik Kjus and Johannessen, Hans Olaf and Hjortland, Geir Olav and Bartella, Isabel and Schröder, Wolfgang and Bruns, Christiane and Nilsson, Magnus}},
  issn         = {{1528-1140}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{684--689}},
  publisher    = {{Lippincott Williams & Wilkins}},
  series       = {{Annals of Surgery}},
  title        = {{Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial : Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer}},
  url          = {{http://dx.doi.org/10.1097/SLA.0000000000004340}},
  doi          = {{10.1097/SLA.0000000000004340}},
  volume       = {{272}},
  year         = {{2020}},
}