Incidence and Grading of Complications After Gastrectomy for Cancer Using the GASTRODATA Registry: A European Retrospective Observational Study.

OBJECTIVE: Utilizing a standardized dataset based on a newly developed list of 27 univocally defined complications, this study analyzed data to assess the incidence and grading of complications and evaluate outcomes associated with gastrectomy for cancer in Europe. SUMMARY BACKGROUND DATA: The absence of a standardized system for recording gastrectomy-associated complications makes it difficult to compare results from different hospitals and countries. METHODS: Using a secure online platform (www.gastrodata.org), referral centers for gastric cancer in 11 European countries belonging to the Gastrectomy Complications Consensus Group recorded clinical, oncological, and surgical data, and outcome measures at hospital discharge and at 30 and 90 days postoperatively. This retrospective observational study included all consecutive resections over a 2-year period. RESULTS: A total of 1349 gastrectomies performed between January 2017 and December 2018 were entered into the database. Neoadjuvant chemotherapy was administered to 577 patients (42.8%). Total (46.1%) and subtotal (46.4%) gastrectomy were the predominant resections. D2 or D2+ lymphadenectomy was performed in almost 80% of operations. The overall complications' incidence was 29.8%; 402 patients developed 625 complications, with the most frequent being nonsurgical infections (23%), anastomotic leak (9.8%), other postoperative abnormal fluid from drainage and/or abdominal collections (9.3%), pleural effusion (8.3%), postoperative bleeding (5.6%), and other major complications requiring invasive treatment (5.6%). The median Clavien-Dindo score and Comprehensive Complications Index were IIIa and 26.2, respectively. In-hospital, 30-day, and 90-day mortality were 3.2%, 3.6%, and 4.5%, respectively. CONCLUSIONS: The use of a standardized platform to collect European data on perioperative complications revealed that gastrectomy for gastric cancer is still associated with heavy morbidity and mortality. Actions are needed to limit the incidence of, and to effectively treat, the most frequent and most lethal complications.

International consensus on a complications list after gastrectomy for cancer.

BACKGROUND: Perioperative complications can affect outcomes after gastrectomy for cancer, with high mortality and morbidity rates ranging between 10 and 40%. The absence of a standardized system for recording complications generates wide variation in evaluating their impacts on outcomes and hinders proposals of quality-improvement projects. The aim of this study was to provide a list of defined gastrectomy complications approved through international consensus. METHODS: The Gastrectomy Complications Consensus Group consists of 34 European gastric cancer experts who are members of the International Gastric Cancer Association. A group meeting established the work plan for study implementation through Delphi surveys. A consensus was reached regarding a set of standardized methods to define gastrectomy complications. RESULTS: A standardized list of 27 defined complications (grouped into 3 intraoperative, 14 postoperative general, and 10 postoperative surgical complications) was created to provide a simple but accurate template for recording individual gastrectomy complications. A consensus was reached for both the list of complications that should be considered major adverse events after gastrectomy for cancer and their specific definitions. The study group also agreed that an assessment of each surgical case should be completed at patient discharge and 90 days postoperatively using a Complication Recording Sheet. CONCLUSION: The list of defined complications (soon to be validated in an international multicenter study) and the ongoing development of an electronic datasheet app to record them provide the basic infrastructure to reach the ultimate goals of standardized international data collection, establishment of benchmark results, and fostering of quality-improvement projects.

Intraoperative ICG-based imaging of liver neoplasms: a simple yet powerful tool. Preliminary results.

BACKGROUND: Detecting small nodules that are grossly unidentifiable remains a major challenge in liver resection for cancer. Novel developments in navigation surgery, especially indocyanine green (ICG)-based fluorescence imaging, are making a clear breakthrough in addressing this issue. ICG is almost routinely administered during the preoperative stage in hepatobiliary surgery. However, its full potential has yet to be realized, partly because there are no precise guidelines regarding the optimal dose or timing of ICG injections before liver surgery. The main goal of this study was to design an algorithm for the management of ICG injections to achieve optimal liver staining results. METHODS: Twenty-seven consecutive, unselected patients undergoing liver resection for cancer were enrolled and underwent preoperative liver function assessment by the LiMON test. Extra ICG i.v. injections at different doses and timings were performed. In vivo intraoperative analysis of the stain detected by near-infrared fluorescence imaging of the liver and ex vivo analysis of each resected nodule was performed and compared to the pathological analysis. RESULTS: (i) The success rate of ICG injections in terms of liver staining was 92.6%; (ii) in the absence of or with 7 or more days from a previous ICG injection, the best dose to inject before the operation was 0.2 mg/kg, and the best timing was between 24 and 48 h before the scheduled surgery; and (iii) the ICG fluorescence patterns observed in the tumors were total fluorescence staining (41% of the cases), partial fluorescence staining (15%), rim fluorescence staining surrounding the tumor (30%), and no staining (15%). CONCLUSIONS: This study is a building block for the characterization of liver nodules and the search for additional surface lesions undetected by preoperative radiological work-up-a crucial task for the successful treatment of liver cancer at an early stage using a safe, minimally invasive, and inexpensive technique.

Fluorescence-guided lymphadenectomy in gastric cancer: a prospective western series.

BACKGROUND: Indocyanine green (ICG) has been recently introduced in clinical practice as a fluorescent tracer. Lymphadenectomy is particularly challenging in gastric cancer surgery, owing to the complex anatomical drainage. AIM: The primary outcomes of this study were the feasibility and usefulness of ICG-guided lymphadenectomy in gastric cancer surgery, considering both the success rate and improved understanding of the surgical anatomy of nodal basins. The secondary outcome was the diagnostic ability of ICG to predict the presence of nodal metastases. PATIENTS AND METHODS: We conducted a single-center prospective trial comprising 13 patients with gastric cancer. ICG was injected the afternoon prior to surgery or intraoperatively via the submucosal or subserosal route. Standard lymphadenectomy was performed in all patients, according to patient age and tumor stage, as usual, but after standard lymphadenectomy the residual ICG + nodes were harvested and analyzed. Each nodal station and each dissected node was recorded and classified as ICG + or ICG- (both in vivo and back table evaluation was utilized for classification). After pathological analysis, each nodal station and each dissected node was recorded as metastatic or nonmetastatic (E&E staining). RESULTS: The feasibility rate was 84.6% (11/13). The mean number of dissected lymph nodes per patient was 37.9. Focusing on the 11 patients in whom ICG-guided nodal navigation was successfully performed, 81 lymph node stations were removed, for a total of 417 lymph nodes. Sixty-six stations (81.48%), comprising a total of 336 lymph nodes, exhibited fluorescence. No IC- node was metastatic; all 54 metastatic nodes were ICG + . A total of 282 ICG + nodes were nonmetastatic. In two cases, some nodes outside D2 areas were harvested, being ICG + (1 case of metastatic node). CONCLUSIONS: Fluorescence lymphography-guided lymphadenectomy is a promising new technique that combines a high feasibility rate with considerable ease of use. Regarding its diagnostic value, the key finding from this prospective series is that no metastatic nodes were found outside fluorescent lymph node stations. Further studies are needed to investigate whether this technique can help surgeons performing standard lymphadenectomy and selecting cases for D2 + lymphadenectomy.

Recurrence in node-negative advanced gastric cancer: Novel findings from an in-depth pathological analysis of prognostic factors from a multicentric series.

AIM: To analyze the clinicopathological characteristics of patients with both node-negative gastric carcinoma and diagnosis of recurrence during follow-up. METHODS: We enrolled 41 patients treated with curative gastrectomy for pT2-4aN0 gastric carcinoma between 1992 and 2010, who developed recurrence (Group 1). We retrospectively selected this group from the prospectively collected database of 4 centers belonging to the Italian Research Group for Gastric Cancer, and compared them with 437 pT2-4aN0 patients without recurrence (Group 2). We analyzed lymphatic embolization, microvascular infiltration, perineural infiltration, and immunohistochemical determination of p53, Ki67, and HER2 in Group 1 and in a subgroup of Group 2 (Group 2bis) of 41 cases matched with Group 1 according to demographic and pathological characteristics. RESULTS: T4a stage and diffuse histotype were associated with recurrence in the group of pN0 patients. In-depth pathological analysis of two homogenous groups of pN0 patients, with and without recurrence during long-term follow-up (groups 1 and 2bis), revealed two striking patterns: lymphatic embolization and perineural infiltration (two parameters that pathologists can easily report), and p53 and Ki67, represent significant factors for recurrence. CONCLUSION: The reported pathological features should be considered predictive factors for recurrence and could be useful to stratify node-negative gastric cancer patients for adjuvant treatment and tailored follow-up.