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Original article Clinical endoscopy| Volume 92, ISSUE 2, P368-379, August 2020

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Prospective randomized trial comparing the pocket-creation method and conventional method of colorectal endoscopic submucosal dissection

Published:February 29, 2020DOI:https://doi.org/10.1016/j.gie.2020.02.034

      Background and Aims

      Colorectal endoscopic submucosal dissection (ESD) is recognized as a challenging procedure. Previously, we reported that a new ESD strategy using the pocket-creation method (PCM) is useful for colorectal ESD, but no prospective randomized study has evaluated the efficacy of the PCM. The aim of this study was to evaluate the efficacy and safety of PCM for colorectal ESD compared with the conventional method (CM).

      Methods

      This was a prospective randomized controlled trial at 3 institutions in Japan. Patients with superficial colorectal neoplastic lesions >20 mm predicted to be intramucosal were randomly assigned to undergo ESD using the PCM or CM. Primary outcome was the ESD completion rate defined as completion of colorectal ESD with an en bloc resection using the assigned ESD method without changing to other methods or assisted by other devices.

      Results

      We analyzed 59 patients with 59 colorectal tumors in the PCM group and 55 in the CM group. The ESD completion rate was significantly higher in the PCM group compared with the CM group (93% [55/59] vs 73% [40/55]; P  = .01). En bloc resection rates, R0 resection rates, procedure time, and dissection speed were not significantly different between the 2 groups. The incidence of adverse events was similar in the 2 groups.

      Conclusions

      Use of the PCM allows the endoscopist to complete the procedure with the intended method more often than the CM with similar clinical outcomes. (Clinical trial registration number: UMIN 000024394.)

      Graphical abstract

      Abbreviations:

      CM (conventional method), ESD (endoscopic submucosal dissection), ITT (intention-to-treat), LST-G (laterally spreading tumor granular type), LST-NG (laterally spreading tumor nongranular type), PCM (pocket-creation method)
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      References

        • Zauber A.G.
        • Winawer S.J.
        • O’Brien M.J.
        • et al.
        Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths.
        N Engl J Med. 2012; 366: 687-696
        • Belderbos T.D.G.
        • Leenders M.
        • Moons L.M.G.
        • et al.
        Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis.
        Endoscopy. 2014; 46: 388-402
        • Hurlstone D.P.
        • Sanders D.S.
        • Cross S.S.
        • et al.
        Colonoscopic resection of lateral spreading tumours: a prospective analysis of endoscopic mucosal resection.
        Gut. 2004; 53: 1334-1339
        • Hotta K.
        • Fujii T.
        • Saito Y.
        • et al.
        Local recurrence after endoscopic resection of colorectal tumors.
        Int J Colorectal Dis. 2009; 24: 225-230
        • 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
        • Ono H.
        • Kondo H.
        • Gotoda T.
        • et al.
        Endoscopic mucosal resection for treatment of early gastric cancer.
        Gut. 2001; 48: 225-229
        • Fujishiro M.
        • Yahagi N.
        • Kakushima N.
        • et al.
        Outcomes of endoscopic submucosal dissection for colorectal epithelial neoplasms in 200 consecutive cases.
        Clin Gastroenterol Hepatol. 2007; 5: 678-683
        • Takeuchi Y.
        • Uedo N.
        • Iishi H.
        • et al.
        Endoscopic submucosal dissection with insulated-tip knife for large mucosal early gastric cancer: a feasibility study (with videos).
        Gastrointest Endosc. 2007; 66: 186-193
        • Yamamoto H.
        • Yahagi N.
        • Oyama T.
        Mucosectomy in the colon with endoscopic submucosal dissection.
        Endoscopy. 2005; 37: 764-768
        • Homma K.
        • Otaki Y.
        • Sugawara M.
        • et al.
        Efficacy of novel SB knife Jr examined in a multicenter study on colorectal endoscopic submucosal dissection.
        Dig Endosc. 2012; 24: 117-120
        • Yamashina T.
        • Takeuchi Y.
        • Nagai K.
        • et al.
        Scissor-type knife significantly improves self-completion rate of colorectal endoscopic submucosal dissection: single-center prospective randomized trial.
        Dig Endosc. 2017; 29: 322-329
        • Yamamoto K.
        • Hayashi S.
        • Saiki H.
        • et al.
        Endoscopic submucosal dissection for large superficial colorectal tumors using the “clip-flap” method.
        Endoscopy. 2015; 47: 262-265
        • Yamasaki Y.
        • Takeuchi Y.
        • Uedo N.
        • et al.
        Efficacy of traction-assisted colorectal endoscopic submucosal dissection using a clip-and-thread technique: a prospective randomized study.
        Dig Endosc. 2018; 30: 467-476
        • Yamashina T.
        • Hayashi Y.
        • Sakamoto H.
        • et al.
        Balloon-assisted endoscopy facilitates endoscopic submucosal dissection of difficult superficial proximal colon tumors.
        Endoscopy. 2018; 50: 800-808
        • Sakamoto H.
        • Hayashi Y.
        • Miura Y.
        • et al.
        Pocket-creation method facilitates endoscopic submucosal dissection of colorectal laterally spreading tumors, non-granular type.
        Endosc Int Open. 2017; 5: E123-E129
        • Miura Y.
        • Shinozaki S.
        • Hayashi Y.
        • et al.
        Duodenal endoscopic submucosal dissection is feasible using the pocket-creation method.
        Endoscopy. 2016; 49: 8-14
        • Hayashi Y.
        • Shinozaki S.
        • Sunada K.
        • et al.
        Efficacy and safety of endoscopic submucosal dissection for superficial colorectal tumors more than 50 mm in diameter.
        Gastrointest Endosc. 2016; 83: 602-607
        • Hayashi Y.
        • Miura Y.
        • Yamamoto H.
        Pocket-creation method for the safe, reliable, and efficient endoscopic submucosal dissection of colorectal lateral spreading tumors.
        Dig Endosc. 2015; 27: 534-535
        • Miura Y.
        • Hayashi Y.
        • Lefor A.K.
        • et al.
        The pocket-creation method of ESD for gastric neoplasms.
        Gastrointest Endosc. 2016; 83: 457-458
        • Hayashi Y.
        • Sunada K.
        • Takahashi H.
        • et al.
        Pocket-creation method of endoscopic submucosal dissection to achieve en bloc resection of giant colorectal subpedunculated neoplastic lesions.
        Endoscopy. 2014; 46: E421-E422
        • Takezawa T.
        • Hayashi Y.
        • Shinozaki S.
        • et al.
        The Pocket-creation method facilitates colonic endoscopic submucosal dissection (with video).
        Gastrointest Endosc. 2019; 89: 1045-1053
        • Oyama T.
        • Tomori A.
        • Hotta K.
        • et al.
        ESD with a hook knife for early esophageal cancer.
        Stomach Intest. 2006; 41: 491-497
        • Yamamoto H.
        Endoscopic submucosal dissection for colorectal tumors. Interventional and therapeutic gastrointestinal endoscopy.
        Front Gastrointest Res. 2010; 27: 287-295
        • Linghu E.
        • Li H.
        • Huang Q.
        • Wang X.
        • et al.
        Using tunnel technology dissecting long circumferential lesions of esophagus.
        Zhongguo Jixu Yixue Jiaoyu. 2011; 3: 69-71
        • Schulz K.F.
        • Altman D.G.
        • Moher D.
        CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
        BMJ. 2010; 340: c332
        • Hashiguchi Y.
        • Muro K.
        • Saito Y.
        • et al.
        Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer.
        Int J Clin Oncol. 2020; 25: 1-42
        • Saito Y.
        • Uraoka T.
        • Yamaguchi Y.
        • et al.
        A prospective, multicenter study of 1111 colorectal endoscopic submucosal dissections (with video).
        Gastrointest Endosc. 2010; 72: 1217-1225
        • Takeuchi Y.
        • Iishi H.
        • Tanaka S.
        • et al.
        Factors associated with technical difficulties and adverse events of colorectal endoscopic submucosal dissection: retrospective exploratory factor analysis of a multicenter prospective cohort.
        Int J Colorectal Dis. 2014; 29: 1275-1284
        • Sato K.
        • Ito S.
        • Kitagawa T.
        • et al.
        Factors affecting the technical difficulty and clinical outcome of endoscopic submucosal dissection for colorectal tumors.
        Surg Endosc. 2014; 28: 2959-2965
        • Mizushima T.
        • Kato M.
        • Iwanaga I.
        • et al.
        Technical difficulty according to location, and risk factors for perforation, in endoscopic submucosal dissection of colorectal tumors.
        Surg Endosc. 2015; 29: 133-139
        • Hayashi N.
        • Tanaka S.
        • Nishiyama S.
        • et al.
        Predictors of incomplete resection and perforation associated with endoscopic submucosal dissection for colorectal tumors.
        Gastrointest Endosc. 2014; 79: 427-435
        • Taves D.
        Minimization: a new method of assigning patients to treatment and control groups.
        Clin Pharmacol Therap. 1974; 15: 443-453
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
      1. National Cancer Institute. National Cancer Institute Common Terminology Criteria for Adverse Events v.4.0.
        (Available at:) (Accessed April 10, 2016)
        • Saito Y.
        • Fukuzawa M.
        • Matsuda T.
        • et al.
        Clinical outcome of endoscopic submucosal dissection versus endoscopic mucosal resection of large colorectal tumors as determined by curative resection.
        Surg Endosc. 2010; 24: 343-352
        • Spychalski M.
        • Dziki A.
        Safe and efficient colorectal endoscopic submucosal dissection in European settings: Is successful implementation of the procedure possible?.
        Dig Endosc. 2015; 27: 368-373
        • Coumaros D.
        • Vincent F.
        Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) for superficial colorectal neoplastic lesions: a European experience [abstract].
        Gastrointest Endosc. 2012; 75: AB427
        • Kawamura T.
        • Takeuchi Y.
        • Asai S.
        • et al.
        A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study).
        Gut. 2018; 67: 1950-1957
        • Matsuura N.
        • Takeuchi Y.
        • Yamashina T.
        • et al.
        Incomplete resection rate of cold snare polypectomy: a prospective single-arm observational study.
        Endoscopy. 2017; 49: 251-257
        • Yamashina T.
        • Fukuhara M.
        • Maruo T.
        • et al.
        Cold snare polypectomy reduced delayed postpolypectomy bleeding compared with conventional hot polypectomy: a propensity score-matching analysis.
        Endosc Int Open. 2017; 05: E587-E594
        • Binmoeller K.F.
        • Weilert F.
        • Shah J.
        • et al.
        EMR without submucosal injection for large sessile colorectal polyps (with video).
        Gastrointest Endosc. 2012; 75: 1086-1091
        • Yamashina T.
        • Uedo N.
        • Akasaka T.
        • et al.
        Comparison of underwater vs conventional endoscopic mucosal resection of intermediate-size colorectal polyps.
        Gastroenterology. 2019; 157: 451-461
        • Tajika M.
        • Niwa Y.
        • Bhatia V.
        • et al.
        Comparison of endoscopic submucosal dissection and endoscopic mucosal resection for large colorectal tumors.
        Eur J Gastroenterol Hepatol. 2011; 23: 1042-1049
        • Lee E.-J.
        • Lee J.B.
        • Lee S.H.
        • et al.
        Endoscopic treatment of large colorectal tumors: comparison of endoscopic mucosal resection, endoscopic mucosal resection-precutting, and endoscopic submucosal dissection.
        Surg Endosc. 2012; 26: 2220-2230
        • Toyonaga T.
        • Man-i M.
        • Fujita T.
        • et al.
        Retrospective study of technical aspects and complications of endoscopic submucosal dissection for laterally spreading tumors of the colorectum.
        Endoscopy. 2010; 42: 714-722
        • Yoshida N.
        • Naito Y.
        • Yasuda R.
        • et al.
        The efficacy of the pocket-creation method for cases with severe fibrosis in colorectal endoscopic submucosal dissection.
        Endosc Int Open. 2018; 6: E975-E983

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