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Surgicopathological Quality Control and Protocol Adherence to Lymphadenectomy in the CRITICS Gastric Cancer Trial

Claassen, Yvette H. M., MD*; de Steur, Wobbe O., MD*; Hartgrink, Henk H., MD, PhD*; Dikken, Johan L., MD, PhD*; van Sandick, Johanna W., MD, PhD; van Grieken, Nicole C. T., MD, PhD; Cats, Annemiek, MD, PhD§; Trip, Anouk K., MD, PhD; Jansen, Edwin P. M., MD, PhD; Kranenbarg, Willemina M. Meershoek-Klein, MSc*; Braak, Jeffrey P. B. M., BSc*; Putter, Hein, PhD||; van Berge Henegouwen, Mark I., MD, PhD**; Verheij, Marcel, MD, PhD; van de Velde, Cornelis J. H., MD, PhD*

doi: 10.1097/SLA.0000000000002444
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Objective: The purpose of this study was to evaluate surgicopathological quality and protocol adherence for lymphadenectomy in the CRITICS trial.

Summary of Background Data: Surgical quality assurance is a key element in multimodal studies for gastric cancer. In the multicenter CRITICS trial (ChemoRadiotherapy after Induction chemotherapy In Cancer of the Stomach), patients with resectable gastric cancer were randomized for preoperative chemotherapy, followed by gastrectomy with a D1+ lymphadenectomy (removal of stations 1 to 9 and 11), followed by either chemotherapy or chemoradiotherapy.

Methods: Surgicopathological compliance was defined as removal of ≥15 lymph nodes. Surgical compliance was defined as removal of the indicated lymph node stations. Surgical contamination was defined as removal of lymph node stations that should be left in situ. The Maruyama Index (MI, lower is better), which has proven to be an indicator of surgical quality and is strongly associated with survival, was analyzed.

Results: Between 2007 and 2015, 788 patients were randomized, of whom 636 patients underwent a gastrectomy with curative intent. Surgicopathological compliance occurred in 72.8% (n = 460) of the patients and improved from 55.0% (2007) to 90.0% (2015). Surgical compliance occurred in 41.1% (n = 256). Surgical contamination occurred in 59.6% (n = 371). Median MI was 1 (range 0 to 136).

Conclusion: Surgical quality in the CRITICS trial was excellent, with a MI of 1. Surgicopathological compliance improved over the years. This might be explained by the quality assurance program within the study and centralization of gastric cancer surgery in the Netherlands.

*Department of Surgical Oncology, Leiden University Medical Center, Leiden, The Netherlands

Department of Surgical Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands

§Department of Gastrointestinal Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

||Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands

**Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.

Reprints: Prof. Cornelis J. H. van de Velde, MD, PhD, Leiden University Medical Center, Department of Surgery, K6-R, P.O. Box 9600, 2300 RC Leiden, The Netherlands. E-mail: C.J.H.van_de_Velde@lumc.nl.

Y.H.M. Claassen and W.O. de Steur have contributed equally to this manuscript and share the first authorship.

The authors would like to thank Henk Boot for his contribution in designing the CRITICS trial and principal investigators of all participating hospitals in the CRITICS trial. All authors substantially contributed to the conception and design or analysis and interpretation of the data; drafting the article or revising it critically; and approved the final version.

No conflicts of interest were reported for all authors. This research did not receive any specific grant from funding agencies in the public, commercial, or nonprofit sectors.

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