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Background and aim <p>A newly developed tip-type needle injection knife (TK) can pump fluid through its tip. In this study, we aimed to evaluate the efficacy and safety of a TK in colorectal endoscopic submucosal dissection (ESD) compared with a conventional sheath-type needle injection knife (DK).</p> Methods <p>This prospective, multi-center, randomized controlled trial included patients with superficial colorectal tumors measuring 20–50&#xa0;mm. The patients were randomly assigned to either the TK or DK group. The primary and secondary outcomes were procedure time and ESD procedure details, respectively.</p> Results <p>The TK and DK groups comprised 130 and 125 patients, respectively. Baseline characteristics were not significantly different between the two groups. No significant differences were observed in procedure time or dissection speed. However, the TK group required significantly fewer intraprocedural device insertions/removals. Total local injection volume was also significantly lower in the TK group than in the DK group. The number of intraoperative perforations did not significantly differ between the groups. Among lesions ≥ 30&#xa0;mm, the TK group had a significantly shorter procedure time and faster dissection speed.</p> Conclusions <p>The TK and DK demonstrated comparable efficacy and safety. However, the lower number of device insertions/removals with the TK suggested greater procedural convenience. For colorectal ESD procedures involving lesions ≥ 30&#xa0;mm, the TK may also reduce procedure time more effectively than the DK.</p> Clinical trial registration <p>UMIN Clinical Trials Registry (UMIN-CTR) UMIN 000052397.</p>

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Efficacy and safety of a needle-type knife that injects fluid through its tip compared with a conventional needle-injection knife for colorectal endoscopic submucosal dissection: a randomized controlled trial (with video)

  • 期刊论文

  • 发表日期：

    2025年12月3日

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  • Yuki Kano,
  • Eiji Sakai,
  • Risato Takeda,
  • Makoto Koda,
  • Taku Morita,
  • Hideyuki Chiba,
  • Etsuko Yamabe,
  • Rikimaru Sawada,
  • Toshifumi Iida,
  • Susumu Banjoya,
  • Tomoya Kimura,
  • Naoki Tomita,
  • Koichi Furuta,
  • Shinya Nagae,
  • Hiroshi Yamazaki,
  • Yoshiaki Kimoto,
  • Syunya Takayanagi,
  • Nao Takeuchi,
  • Kohei Ono,
  • Ryoju Negishi,
  • Yohei Minato,
  • Ken Ohata

摘要

Background and aim

A newly developed tip-type needle injection knife (TK) can pump fluid through its tip. In this study, we aimed to evaluate the efficacy and safety of a TK in colorectal endoscopic submucosal dissection (ESD) compared with a conventional sheath-type needle injection knife (DK).

Methods

This prospective, multi-center, randomized controlled trial included patients with superficial colorectal tumors measuring 20–50 mm. The patients were randomly assigned to either the TK or DK group. The primary and secondary outcomes were procedure time and ESD procedure details, respectively.

Results

The TK and DK groups comprised 130 and 125 patients, respectively. Baseline characteristics were not significantly different between the two groups. No significant differences were observed in procedure time or dissection speed. However, the TK group required significantly fewer intraprocedural device insertions/removals. Total local injection volume was also significantly lower in the TK group than in the DK group. The number of intraoperative perforations did not significantly differ between the groups. Among lesions ≥ 30 mm, the TK group had a significantly shorter procedure time and faster dissection speed.

Conclusions

The TK and DK demonstrated comparable efficacy and safety. However, the lower number of device insertions/removals with the TK suggested greater procedural convenience. For colorectal ESD procedures involving lesions ≥ 30 mm, the TK may also reduce procedure time more effectively than the DK.

Clinical trial registration

UMIN Clinical Trials Registry (UMIN-CTR) UMIN 000052397.