Trial reportJournal of gastroenterology and hepatology2025
The Comparison Between Low- and High-Concentration Injection Solution Ability for Colorectal Endoscopic Submucosal Dissection.
Trial report in Journal of gastroenterology and hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Dye-free versus dye-containing submucosal injection solutions in ESD for colorectal LST: a multi-center retrospective study on efficacy and safety.Surgical endoscopy · 2026Article
- Improvement in the Visibility of Submucosal Layers and Vessels with Amber-Red Color Imaging in Colorectal Endoscopic Submucosal Dissection.Digestive diseases and sciences · 2026Observational
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimInjection solution is important for achieving submucosal elevation in endoscopic submucosal dissection (ESD) and various viscous solutions categorized as low-concentration injection solution (LCS) or high-concentration injection solution (HCS) are used. We analyzed the difference between LCS and HCS in colorectal ESD.
methodsThis was a prospective, randomized controlled trial at six Japanese institutions. Patients with early neoplastic lesions of ≥ 20 mm were enrolled from March 2022 to September 2023. Sodium alginate (Liftal K, Kaigen Pharma Co., Osaka, Japan) was used as the injection solution, and the concentration of HCS and LCS was set at 0.6% and 0.3%, respectively. Participants were randomized to HCS or LCS groups and the primary endpoint was the noninferiority about ESD procedure time of LCS compared to HCS.
resultsThe LCS and HCS groups consisted of 79 and 82 cases, respectively. The ESD procedure time (min, mean ± standard deviation) was significantly noninferior between the LCS and HCS groups (p < 0.001) and was significantly shorter in the LCS group than in the HCS group (61.9 ± 39.2 vs. 76.9 ± 67.5, p = 0.044). There were no significant differences in en bloc resection (98.7% vs. 100.0%, p = 0.985), perioperative perforation (2.5% vs. 2.4%, p = 0.639), and delayed bleeding (1.3% vs. 1.2%, p = 0.493). In the subgroup analysis, the ESD procedure times were significant for lesions of ≥ 40 mm (74.3 ± 30.4 vs. 125.3 ± 107.2, p = 0.031) and experts (51.5 ± 29.2 vs. 69.4 ± 58.9, p = 0.046). Additionally, injection volumes (mL) were not significant (38.0 ± 20.2 vs. 33.0 ± 27.0, p = 0.098) in the two groups.
conclusionLCS was noninferior to HCS in terms of procedure time and significantly reduced it.
trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry number: UMIN000048661.
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