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

Authors

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)

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

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