Gut Liver.  2022 Jan;16(1):44-52. 10.5009/gnl210103.

A Novel One-Step Knife Approach Can Reduce the Submucosal Injection Time of Endoscopic Submucosal Dissection: A SingleBlinded Randomized Multicenter Clinical Trials

Affiliations
  • 1Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
  • 2Center of Evidence Based Medicine, Institute of Convergence Science, Yonsei University, Seoul, Korea.
  • 3Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
  • 4Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea.
  • 5Department of Internal Medicine, University of Ulsan College of Medicine, Gangneung, Korea.
  • 6Department of Biostatistics Center of Biomedical Data Science, Yonsei University Wonju College of Medicine, Wonju, Korea.

Abstract

Background/Aims
Endoscopic submucosal dissection (ESD) is a curative treatment modality for early gastric neoplasms; however, ESD can be a time-consuming process. To overcome this pitfall, we developed the one-step knife (OSK) approach, which combines an endoscopic knife and injection needle on a single sheath. We aimed to evaluate whether this approach could reduce the ESD procedure time.
Methods
This single-blinded randomized multicenter trial at four tertiary hospitals from June 2019 to June 2020 included patients aged 19 to 85 years undergoing ESD. Patients were randomly assigned to two groups (OSK or conventional knife [CK]). The injection time, total procedure time, resected specimen size, submucosal fluid amount, degree of device satisfaction, and adverse events were evaluated and compared between groups.
Results
Fifty-one patients were analyzed (OSK: 25 patients and CK: 26 patients). No baseline differences were observed between groups, with the exception of a higher portion of males in the OSK group. The mean injection time was significantly reduced in the OSK group (39.0 seconds) compared to that in the CK group (87.5 seconds, p<0.001). A decrease of more than 10 minutes in the total procedure time (18.0 minutes vs 28.1 minutes, p=0.055) in the OSK group compared to the CK group was observed. Second-look esophagogastroduodenoscopy revealed two delayed bleeding cases in the OSK group that were easily controlled by endoscopic hemostasis.
Conclusions
OSK reduced the injection time and showed a decrease in total procedure time compared with the CK approach. OSK can be a feasible tool for ESD, especially in difficult cases.

Keyword

Gastric cancer; Endoscopic submucosal dissection; Submucosal injection; Procedure time
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