Yan Ke1, Sanne N van Munster2, Liyan Xue3, Shun He1, Yueming Zhang1, Lizhou Dou1, Yong Liu1, Xudong Liu1, Yumeng Liu1, Wei Li1, Ning Lv3, Sanford M Dawsey4, Bas L A M Weusten5, Jacques J G H M Bergman6, Guiqi Wang1. 1. Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 2. Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands. 3. Department of Pathology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China. 4. Department of Cancer Epidemiology & Genetics, National Cancer Institute, Bethesda, Maryland, USA. 5. Department of Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Gastroenterology & Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands. 6. Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands.
Abstract
BACKGROUND AND AIMS: Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to cancer. Current treatment options, endoscopic mucosal resection (EMR) or submucosal dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS) is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability, and efficacy of CbFAS for eradication of ESCN. METHODS: In this single-center prospective trial in China, patients with 1 flat unstained lesion (USL) on Lugol chromoendoscopy that contained moderate- or high-grade intraepithelial neoplasia (MGIN or HGIN, respectively) were enrolled. CbFAS was performed using side-by-side applications of 10 seconds, treatment was repeated at 3-month intervals until a complete response (CR) was established. The response at 12 months was the primary trial endpoint. Safety phone calls were performed at 2, 7, and 30 days after the initial CbFAS. RESULTS: We enrolled 80 patients (59 MGIN, 21 HGIN) with a median USL length of 3 cm (interquartile range [IQR], 3-4). Seventy-nine received treatment, with a median of 5 side-by-side applications (IQR, 4-7) per patient over a median of 8 minutes (IQR, 5-10). After a single treatment, 70 of 78 patients (90%) exhibited CR, and 1 was lost to follow-up. The other 8 with persisting USLs were retreated, and all achieved CR after this second treatment. At 12 months after the initial CbFAS, 76 of 78 patients (97%) exhibited CR and 2 (3%) had recurrent MGIN. No strictures or serious adverse events occurred. Four patients developed self-limiting mucosal lacerations on balloon inflation. The postprocedure median pain score was 1 of 10 (IQR, 0-2) at day 2 and 0 (0-0) at days 7 and 30. CONCLUSIONS: The results suggest that the CbFAS is safe, well tolerated, and effective in inducing endoscopic and histologic remission in patients with ESCN of limited size. (Clinical trial registration number: NCT02605759.).
BACKGROUND AND AIMS: Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to cancer. Current treatment options, endoscopic mucosal resection (EMR) or submucosal dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS) is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability, and efficacy of CbFAS for eradication of ESCN. METHODS: In this single-center prospective trial in China, patients with 1 flat unstained lesion (USL) on Lugol chromoendoscopy that contained moderate- or high-grade intraepithelial neoplasia (MGIN or HGIN, respectively) were enrolled. CbFAS was performed using side-by-side applications of 10 seconds, treatment was repeated at 3-month intervals until a complete response (CR) was established. The response at 12 months was the primary trial endpoint. Safety phone calls were performed at 2, 7, and 30 days after the initial CbFAS. RESULTS: We enrolled 80 patients (59 MGIN, 21 HGIN) with a median USL length of 3 cm (interquartile range [IQR], 3-4). Seventy-nine received treatment, with a median of 5 side-by-side applications (IQR, 4-7) per patient over a median of 8 minutes (IQR, 5-10). After a single treatment, 70 of 78 patients (90%) exhibited CR, and 1 was lost to follow-up. The other 8 with persisting USLs were retreated, and all achieved CR after this second treatment. At 12 months after the initial CbFAS, 76 of 78 patients (97%) exhibited CR and 2 (3%) had recurrent MGIN. No strictures or serious adverse events occurred. Four patients developed self-limiting mucosal lacerations on balloon inflation. The postprocedure median pain score was 1 of 10 (IQR, 0-2) at day 2 and 0 (0-0) at days 7 and 30. CONCLUSIONS: The results suggest that the CbFAS is safe, well tolerated, and effective in inducing endoscopic and histologic remission in patients with ESCN of limited size. (Clinical trial registration number: NCT02605759.).
Authors: F G van Vilsteren; L Alvarez Herrero; R E Pouw; F J ten Kate; M Visser; C A Seldenrijk; M I van Berge Henegouwen; B L Weusten; J J Bergman Journal: Endoscopy Date: 2011-03-31 Impact factor: 10.093
Authors: G-Q Wang; C C Abnet; Q Shen; K J Lewin; X-D Sun; M J Roth; Y-L Qiao; S D Mark; Z-W Dong; P R Taylor; S M Dawsey Journal: Gut Date: 2005-02 Impact factor: 23.059
Authors: Jacques Ferlay; Isabelle Soerjomataram; Rajesh Dikshit; Sultan Eser; Colin Mathers; Marise Rebelo; Donald Maxwell Parkin; David Forman; Freddie Bray Journal: Int J Cancer Date: 2014-10-09 Impact factor: 7.396