Multicenter prospective randomized controlled clinical trial comparing the pocket-creation method with and without single-clip traction of colonic endoscopic submucosal dissection

Takaaki Morikawa; Daiki Nemoto; Tomohiro Kurokawa; Takeshi Yamashina; Yoshikazu Hayashi; Masafumi Kitamura; Masahiro Okada; Takahito Takezawa; Yuki Nakajima; Yuka Kowazaki; Hisashi Fukuda; Tatsuma Nomura; Nikolaos Lazaridis; Noriyoshi Fukushima; Keijiro Sunada; Hironori Yamamoto

doi:10.1055/a-2276-0546

Endoscopy, Inhaltsverzeichnis

Endoscopy 2024; 56(08): 583-593
DOI: 10.1055/a-2276-0546

Original article

Multicenter prospective randomized controlled clinical trial comparing the pocket-creation method with and without single-clip traction of colonic endoscopic submucosal dissection

Takaaki Morikawa

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

²Department of Gastroenterology, Jyoban Hospital of Tokiwa Foundation, Iwaki, Japan

,

Daiki Nemoto

³Department of Coloproctology, Fukushima Medical University Aizu Medical Center, Fukushima, Japan (Ringgold ID: RIN38219)

⁴Department of Gastroenterology, Takeda General Hospital, Fukushima, Japan

,

Tomohiro Kurokawa

²Department of Gastroenterology, Jyoban Hospital of Tokiwa Foundation, Iwaki, Japan

,

Takeshi Yamashina

⁵Division of Gastroenterology and Hepatology,, Kansai Medical University Medical Center, Moriguchi, Japan (Ringgold ID: RIN50196)

,

Yoshikazu Hayashi

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

,

Masafumi Kitamura

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

,

Masahiro Okada

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

,

Takahito Takezawa

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

,

Yuki Nakajima

³Department of Coloproctology, Fukushima Medical University Aizu Medical Center, Fukushima, Japan (Ringgold ID: RIN38219)

,

Yuka Kowazaki

²Department of Gastroenterology, Jyoban Hospital of Tokiwa Foundation, Iwaki, Japan

,

Hisashi Fukuda

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

²Department of Gastroenterology, Jyoban Hospital of Tokiwa Foundation, Iwaki, Japan

,

Tatsuma Nomura

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

⁶Department of Gastroenterology, Mie Prefectural Shima Hospital, Shima, Japan (Ringgold ID: RIN38367)

,

Nikolaos Lazaridis

⁷Royal Free Unit for Endoscopy, The Royal Free Hospital and University College London (UCL) Institute for Liver and Digestive Health, London, UK

,

Noriyoshi Fukushima

⁸Department of Pathology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

,

Keijiro Sunada

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

,

Hironori Yamamoto

¹Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan (Ringgold ID: RIN12838)

› Institutsangaben

Abstract

Background The pocket-creation method (PCM) was developed to overcome the technical difficulties of endoscopic submucosal dissection (ESD), although opening the pocket remains challenging. We developed a novel technique of PCM with single-clip traction (PCM-CT), which uses a reopenable clip as a traction device to maintain stability during the procedure. No prospective study has compared the efficacy of PCM-CT and PCM. This study aimed to investigate the effectiveness of PCM-CT vs. PCM in a randomized controlled trial.

Methods This randomized controlled clinical trial was conducted at four Japanese institutions. Patients with superficial colorectal neoplastic lesions were included following Japanese guidelines for colorectal cancer. Seven moderately experienced endoscopists performed the ESD procedures using either PCM-CT or PCM.

Results 100 patients were enrolled in the study. Compared with PCM, PCM-CT achieved significantly faster mean (SD) dissection speed (21.4 [10.8] vs. 27.0 [14.5] mm2/min [95%CI 0.5 to 10.7], P = 0.03), and reduced the mean procedure time (81.8 [57.9] vs. 64.8 [47.6] minutes [95%CI –38.2 to 4.3], P = 0.12) and pocket-opening time (37.8 [33.0] vs. 30.0 [28.9] minutes [95%CI –20.2 to 4.6], P = 0.22). En bloc and R0 resection rates were not significantly different between the two groups (100% vs. 100%, P >0.99; 100% vs. 96%, P = 0.50, respectively). No significant differences were observed in adverse events between the two groups.

Conclusion ESD facilitated by the novel PCM-CT method appeared to be significantly faster than PCM. Both methods achieved high R0 resection rates.

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Referenzen

References
1 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
2 Saito Y, Otake Y, Sakamoto T. et al. Indications for and technical aspects of colorectal endoscopic submucosal dissection. Gut Liver 2013; 7: 263-269
3 Saito Y, Sakamoto T, Nakajima T. et al. Colorectal ESD: current indications and latest technical advances. Gastrointest Endosc Clin N Am 2014; 24: 245-255
4 Kobayashi N, Takeuchi Y, Ohata K. et al. Outcomes of endoscopic submucosal dissection for colorectal neoplasms: prospective, multicenter, cohort trial. Dig Endosc 2022; 34: 1042-1051
5 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: E421-422
6 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
7 Libânio D, Pimentel-Nunes P, Bastiaansen B. et al. Endoscopic submucosal dissection techniques and technology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy 2023; 55: 361-389
8 Nomura T, Hayashi Y, Lee RF. et al. Pocket-creation method using a new technique of single-clip traction for colorectal endoscopic submucosal dissection. Endoscopy 2020; 52: E208-E210
9 Nomura T, Hayashi Y, Morikawa T. et al. Colorectal endoscopic submucosal dissection using the pocket-creation method with single clip traction: a feasibility study. Endosc Int Open 2021; 9: E653-e658
10 Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010; 8: 18
11 Sano Y, Tanaka S, Kudo SE. et al. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc 2016; 28: 526-533
12 Kudo S, Tamura S, Nakajima T. et al. Diagnosis of colorectal tumorous lesions by magnifying endoscopy. Gastrointest Endosc 1996; 44: 8-14
13 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
14 Yamashina T, Nemoto D, Hayashi Y. et al. Prospective randomized trial comparing the pocket-creation method and conventional method of colorectal endoscopic submucosal dissection. Gastrointest Endosc 2020; 92: 368-379
15 Yamashina T, Hayashi Y, Fukuda H. et al. The pocket-creation method may facilitate endoscopic submucosal dissection of large colorectal sessile tumors. Endosc Int Open 2020; 8: E1021-E1030
16 Nagtegaal ID, Odze RD, Klimstra D. et al. The 2019 WHO classification of tumours of the digestive system. Histopathology 2020; 76: 182-188
17 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
18 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
19 Kanda Y. Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant 2013; 48: 452-458
20 Bordillon P, Pioche M, Wallenhorst T. et al. Double-clip traction for colonic endoscopic submucosal dissection: a multicenter study of 599 consecutive cases (with video). Gastrointest Endosc 2021; 94: 333-343
21 Yamamoto H, Kawata H, Sunada K. et al. Successful en-bloc resection of large superficial tumors in the stomach and colon using sodium hyaluronate and small-caliber-tip transparent hood. Endoscopy 2003; 35: 690-694
22 Hayashi Y, Nomura T, Lee RF. et al. Introducing the next evolution of the small-caliber-tip transparent hood: enhancing the pocket-creation method by building on previous successes. Endoscopy 2020; 52: E297-e299
23 Ritsuno H, Sakamoto N, Osada T. et al. Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Surg Endosc 2014; 28: 3143-3149
24 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
25 Jacques J, Charissoux A, Legros R. et al. Double-clip counter-traction using a rubber band is a useful and adaptive tool for colonic endoscopic submucosal dissection. Endoscopy 2018; 50: 179-181
26 Ichijima R, Ikehara H, Sumida Y. et al. Randomized controlled trial comparing conventional and traction endoscopic submucosal dissection for early colon tumor (CONNECT-C trial). Dig Endosc 2023; 35: 86-93
27 Masgnaux L-J, Grimaldi J, Rivory J. et al. Endoscopic submucosal dissection assisted by adaptive traction: results of the first 54 procedures. Endoscopy 2024; 56: 205-211
28 Hayashi Y, Miura Y, Lefor AK. et al. The pocket-creation method of endoscopic submucosal dissection. Mini-invasive Surg 2022; 6: 7
29 Morikawa T, Hayashi Y, Fukuda H. et al. Endoscopic submucosal dissection of deeply invasive colorectal cancers using the pocket-creation method: analysis of vertical margins. Front Gastroenterol 2022; 1: 879615
30 Kanamori A, Nakano M, Kondo M. et al. Clinical effectiveness of the pocket-creation method for colorectal endoscopic submucosal dissection. Endosc Int Open 2017; 5: E1299-E1305
31 Pei Q, Qiao H, Zhang M. et al. Pocket-creation method versus conventional method of endoscopic submucosal dissection for superficial colorectal neoplasms: a meta-analysis. Gastrointest Endosc 2021; 93: 1038-1046
32 Kitamura M, Miura Y, Shinozaki S. et al. The pocket-creation method facilitates gastric endoscopic submucosal dissection and overcomes challenging situations. VideoGIE 2021; 6: 390-394
33 Kitamura M, Miura Y, Shinozaki S. et al. The pocket-creation method facilitates endoscopic submucosal dissection of gastric neoplasms along the lesser curvature at the gastric angle. Front Med (Lausanne) 2022; 9: 825325
34 Miura Y, Shinozaki S, Hayashi Y. et al. Duodenal endoscopic submucosal dissection is feasible using the pocket-creation method. Endoscopy 2017; 49: 8-14
35 Kobayashi S, Yamada M, Takamaru H. et al. Diagnostic yield of the Japan NBI Expert Team (JNET) classification for endoscopic diagnosis of superficial colorectal neoplasms in a large-scale clinical practice database. United European Gastroenterol J 2019; 7: 914-923

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