Ferdinando D'Amico1, Arnaldo Amato2, Andrea Iannone3, Cristina Trovato4, Chiara Romana1, Stefano Angeletti5, Roberta Maselli6, Franco Radaelli2, Giancarla Fiori4, Edi Viale7, Emilio Di Giulio5, Paola Soriani8, Mauro Manno8, Emanuele Rondonotti2, Piera Alessia Galtieri6, Andrea Anderloni6, Alessandro Fugazza6, Elisa Chiara Ferrara6, Silvia Carrara6, Milena Di Leo6, Gaia Pellegatta6, Marco Spadaccini1, Laura Lamonaca1, Vincenzo Craviotto1, Paul J Belletrutti9, Cesare Hassan10, Alessandro Repici11. 1. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 2. Gastroenterology Department, Valduce Hospital, Como, Italy. 3. Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. 4. Division of Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico, European Institute of Oncology, Milan, Italy. 5. Digestive Endoscopy Unit, Azienda Ospedaliera Sant'Andrea, Sapienza Università di Roma, Rome, Italy. 6. Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy. 7. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy; Division of Experimental Oncology, Gastroenterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. 8. Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Carpi Hospital, Carpi, Italy. 9. Department of Biomedical Sciences, Humanitas University, Milan, Italy; Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy. 10. Division of Gastroenterology, Nuovo Regina Margherita Hospital, Rome, Italy. 11. Department of Biomedical Sciences, Humanitas University, Milan, Italy; Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy. Electronic address: alessandro.repici@hunimed.eu.
Abstract
BACKGROUND AND AIMS: Granular mixed laterally spreading tumors (GM-LSTs) have an intermediate level of risk for submucosal invasive cancer (SMICs) without clear signs of invasion (covert); the optimal resection method is uncertain. We aimed to determine the risk of covert SMIC in GM-LSTs based on clinical and endoscopic factors. METHODS: We collected data from 693 patients (50.6% male; median age, 69 years) with colorectal GM-LSTs, without signs of invasion, who underwent endoscopic resection (74.2%) or endoscopic submucosal dissection (25.2%) at 7 centers in Italy from 2016 through 2019. We performed multivariate and univariate analyses to identify demographic and endoscopic factors associated with risk of SMIC. We developed a multivariate model to calculate the number needed to treat (NNT) to detect 1 SMIC. RESULTS: Based on pathology analysis, 66 patients (9.5%) had covert SMIC. In multivariate analyses, increased risk of covert SMIC were independently associated with increasing lesion size (odds ratio per mm increase, 1.02, 95% CI, 1.01-1.03; P = .003) and rectal location (odds ratio, 3.08; 95% CI, 1.62-5.83; P = .004). A logistic regression model based on lesion size (with a cutoff of 40 mm) and rectal location identified patients with covert SMIC with 47.0% sensitivity, 82.6% specificity, and an area under the curve of 0.69. The NNT to identify 1 patient with a nonrectal SMIC smaller than 4 cm was 20; the NNT to identify 1 patient with a rectal SMIC of 4 cm or more was 5. CONCLUSIONS: In an analysis of data from 693 patients, we found the risk of covert SMIC in patients with GM-LSTs to be approximately 10%. GM-LSTs of 4 cm or more and a rectal location are high risk and should be treated by en-bloc resection. ClinicalTrials.gov, Number: NCT03836131.
BACKGROUND AND AIMS: Granular mixed laterally spreading tumors (GM-LSTs) have an intermediate level of risk for submucosal invasive cancer (SMICs) without clear signs of invasion (covert); the optimal resection method is uncertain. We aimed to determine the risk of covert SMIC in GM-LSTs based on clinical and endoscopic factors. METHODS: We collected data from 693 patients (50.6% male; median age, 69 years) with colorectal GM-LSTs, without signs of invasion, who underwent endoscopic resection (74.2%) or endoscopic submucosal dissection (25.2%) at 7 centers in Italy from 2016 through 2019. We performed multivariate and univariate analyses to identify demographic and endoscopic factors associated with risk of SMIC. We developed a multivariate model to calculate the number needed to treat (NNT) to detect 1 SMIC. RESULTS: Based on pathology analysis, 66 patients (9.5%) had covert SMIC. In multivariate analyses, increased risk of covert SMIC were independently associated with increasing lesion size (odds ratio per mm increase, 1.02, 95% CI, 1.01-1.03; P = .003) and rectal location (odds ratio, 3.08; 95% CI, 1.62-5.83; P = .004). A logistic regression model based on lesion size (with a cutoff of 40 mm) and rectal location identified patients with covert SMIC with 47.0% sensitivity, 82.6% specificity, and an area under the curve of 0.69. The NNT to identify 1 patient with a nonrectal SMIC smaller than 4 cm was 20; the NNT to identify 1 patient with a rectal SMIC of 4 cm or more was 5. CONCLUSIONS: In an analysis of data from 693 patients, we found the risk of covert SMIC in patients with GM-LSTs to be approximately 10%. GM-LSTs of 4 cm or more and a rectal location are high risk and should be treated by en-bloc resection. ClinicalTrials.gov, Number: NCT03836131.