Endoscopic submucosal dissection with a novel high viscosity injection solution (LiftUp) in an ex vivo model: a prospective randomized study

E. Wedi; P. Koehler; J. Hochberger; J. Maiss; S. Milenovic; M. Gromski; N. Ho; C. Gabor; U. Baulain; V. Ellenrieder; C. Jung

doi:10.1055/a-0874-1844

Endoscopy International Open, Table of Contents

CC BY-NC-ND 4.0 · Endosc Int Open 2019; 07(05): E641-E646
DOI: 10.1055/a-0874-1844

Original article

Endoscopic submucosal dissection with a novel high viscosity injection solution (LiftUp) in an ex vivo model: a prospective randomized study

E. Wedi

¹Department of Gastroenterology and Gastrointestinal Oncology, Center of Interdisciplinary Endoscopy, University Medical Centre Göttingen, Göttingen, Germany

,

P. Koehler

²Institute of Farm Animal Genetics, Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Mariensee, Germany

,

J. Hochberger

³Department of Gastroenterology, Vivantes Klinikum in Friedrichshain, Teaching Hospital of Charité Humboldt University, Berlin, Germany

,

J. Maiss

⁴Department of Gastroenterology, Associates Dr. Kerzel and Prof. Maiss, Forchheim, Germany

,

S. Milenovic

¹Department of Gastroenterology and Gastrointestinal Oncology, Center of Interdisciplinary Endoscopy, University Medical Centre Göttingen, Göttingen, Germany

,

M. Gromski

⁵Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN, USA

,

N. Ho

⁶Ovesco Endoscopy AG, Tübingen, Germany

,

C. Gabor

⁶Ovesco Endoscopy AG, Tübingen, Germany

,

U. Baulain

²Institute of Farm Animal Genetics, Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Mariensee, Germany

,

V. Ellenrieder

¹Department of Gastroenterology and Gastrointestinal Oncology, Center of Interdisciplinary Endoscopy, University Medical Centre Göttingen, Göttingen, Germany

,

C. Jung

¹Department of Gastroenterology and Gastrointestinal Oncology, Center of Interdisciplinary Endoscopy, University Medical Centre Göttingen, Göttingen, Germany

› Author Affiliations

Abstract

Introduction Endoscopic submucosal dissection (ESD) is increasingly being used in the western world. Submucosal injectates are an essential tool for the ESD procedure. In this study, we evaluated a novel copolymer injectate (LiftUp, Ovesco, Tübingen Germany) in an established ESD model (EASIE-R) in comparison to existing submucosal injectables.

Materials and methods We conducted a prospective, randomized ex vivo study performing ESD with three injectates: LiftUp, hydroxyethyl starch (HAES 6 %) and normal saline solution (NaCl 0.9 %). A total of 60 artificial lesions, each 3 × 3 cm in size, were resected in an ex vivo porcine model, utilizing one of the three studied injectates (n = 20 ESDs per injectate). Study parameters were: en bloc resection rate, perforation rate, lifting property, time of injection, injectate volume, general ESD procedure time, and overall procedure time.

Results All 60 lesions were successfully resected using the standard ESD technique. LiftUp had no procedure related perforations, one perforation occurred in the HAES group, and two perforations in the NaCl group (P > 0.05). Furthermore, adequate lifting was achieved in 16/20 (80 %) using LiftUp, 6/20 (30 %) in the HAES group and 6/20 (30 %) in the NaCl group (P < 0.0002). En bloc resection was achieved in 19 (95 %) with LiftUp, in 20 (100 %) with HAES, and in 16 (80 %) with NaCl. General ESD procedure time and overall procedure time were not different among the three groups.

Conclusion LiftUp appears to be a safe alternative to established fluids for ESD. It had a significantly improved lifting effect and required significantly less injected volume compared to well-established lifting solutions.

Full Text

References

References
1 Wang J, Zhang XH, Ge J. et al. Endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal tumors: a meta-analysis. World J Gastroenterol 2014; 20: 8282-8287
2 Hochberger J, Koehler P, Kruse E. et al. Endoscopic submucosal dissection. Der Internist 2013; 54: 287-301
3 Oka S, Tanaka S, Kaneko I. et al. Advantage of endoscopic submucosal dissection compared with EMR for early gastric cancer. Gastrointest Endosc 2006; 64: 877-883
4 Nakamoto S, Sakai Y, Kasanuki J. et al. Indications for the use of endoscopic mucosal resection for early gastric cancer in Japan: a comparative study with endoscopic submucosal dissection. Endoscopy 2009; 41: 746-750
5 Tamegai Y, Saito Y, Masaki N. et al. Endoscopic submucosal dissection: a safe technique for colorectal tumors. Endoscopy 2007; 39: 418-422
6 Fujishiro M, Yahagi N, Kashimura K. et al. Different mixtures of sodium hyaluronate and their ability to create submucosal fluid cushions for endoscopic mucosal resection. Endoscopy 2004; 36: 584-589
7 Ferlitsch M, Moss A, Hassan C. et al. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2017; 49: 270-297
8 Rosenberg N. Submucosal saline wheal as safety factor in fulguration or rectal and sigmoidal polypi. AMA Arch Surg 1955; 70: 120-122
9 Uraoka T, Saito Y, Yamamoto K. et al. Submucosal injection solution for gastrointestinal tract endoscopic mucosal resection and endoscopic submucosal dissection. Drug Des Dev Ther 2009; 2: 131-138
10 Committee AT, Maple JT, Abu Dayyeh BK. et al. Endoscopic submucosal dissection. Gastrointest Endosc 2015; 81: 1311-1325
11 Al-Taie OH, Bauer Y, Dietrich CG. et al. Efficacy of submucosal injection of different solutions inclusive blood components on mucosa elevation for endoscopic resection. Clin Exp Gastroenterol 2012; 5: 43-48
12 Yamamoto H, Yube T, Isoda N. et al. A novel method of endoscopic mucosal resection using sodium hyaluronate. Gastrointest Endosc 1999; 50: 251-256
13 Ferreira AO, Moleiro J, Torres J. et al. Solutions for submucosal injection in endoscopic resection: a systematic review and meta-analysis. Endosc Int Open 2016; 4: E1-E16
14 Yandrapu H, Desai M, Siddique S. et al. Normal saline solution versus other viscous solutions for submucosal injection during endoscopic mucosal resection: a systematic review and meta-analysis. Gastrointest Endosc 2017; 85: 693-699
15 Hochberger J, Matthes K, Maiss J. et al. Training with the compactEASIE biologic endoscopy simulator significantly improves hemostatic technical skill of gastroenterology fellows: a randomized controlled comparison with clinical endoscopy training alone. Gastrointest Endosc 2005; 61: 204-215
16 Schofl R, Buchmeier B, Hauder G. Adaptation of the Erlangen Active Simulator for Interventional Endoscopy (EASIE) model for transmural pancreatic pseudocyst drainage. Endoscopy 2006; 38: 100
17 Gotoda T. A large endoscopic resection by endoscopic submucosal dissection procedure for early gastric cancer. Clin Gastroenterol Hepatol 2005; 3: S71-73
18 Hochberger J, Kruse E, Wedi E. et al. Training in endoscopic mucosal resection and endoscopic submucosal dissection. In: Cohen J. Successful gastrointestinal endoscopy. Oxford: Wiley-Blackwell; 2011: S204-237
19 Repici A, Hassan C, De Paula PessoaD. et al. Efficacy and safety of endoscopic submucosal dissection for colorectal neoplasia: a systematic review. Endoscopy 2012; 44: 137-150
20 Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T. et al. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2015; 47: 829-854
21 Sumiyama K, Toyoizumi H, Ohya TR. et al. A double-blind, block-randomized, placebo-controlled trial to identify the chemical assistance effect of mesna submucosal injection for gastric endoscopic submucosal dissection. Gastrointest Endosc 2014; 79: 756-764
22 Liu W, Zhao M, Liu W. et al. A feasibility study of a thermally sensitive elastin-like polypeptide for submucosal injection application in endoscopic resection in 3 animal models. Gastrointest Endosc 2015; 82: 944-952
23 Kusano T, Etoh T, Akagi T. et al. Evaluation of 0.6% sodium alginate as a submucosal injection material in endoscopic submucosal dissection for early gastric cancer. Dig Endosc 2014; 26: 638-645
24 Kim YD, Lee J, Cho JY. et al. Efficacy and safety of 0.4 percent sodium hyaluronate for endoscopic submucosal dissection of gastric neoplasms. World J Gastroenterol 2013; 19: 3069-3076
25 von Renteln D, Dulai PS, Pohl H. et al. Endoscopic submucosal dissection with a flexible Maryland dissector: randomized comparison of mesna and saline solution for submucosal injection (with videos). Gastrointest Endosc 2011; 74: 906-911
26 Mehta N, Strong AT, Franco M. et al. Optimal injection solution for endoscopic submucosal dissection: a randomized controlled trial of Western solutions in a porcine model. Dig Endosc 2018; 30: 347-353
27 Spadaccini M, Hassan C, Maselli R. et al. Efficacy and safety of SIC-8000 (Eleview(R)) for submucosal injection for endoscopic mucosal resection and endoscopic submucosal dissection in an in vivo porcine model. Dig Liver Dis 2018; 50: 260-266
28 Fasoulas K, Lazaraki G, Chatzimavroudis G. et al. Endoscopic mucosal resection of giant laterally spreading tumors with submucosal injection of hydroxyethyl starch: comparative study with normal saline solution. Surg Laparosc Endosc Percutan Tech 2012; 22: 272-278