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A randomized, single-blind, controlled trial conducted across multiple centers was undertaken to explore the potential protective effects of a newly designed gel for oesophageal wounds resulting from endoscopic submucosal dissection (ESD).
A newly developed gel consisting of colloidal and fixative solutions promotes ulcer healing and protects the ulcer bed after esophageal endoscopic submucosal dissection.
A randomized, single-blind, controlled trial conducted across multiple centers was undertaken to explore the potential protective effects of a newly designed gel for oesophageal wounds resulting from endoscopic submucosal dissection (ESD).
People who had undergone esophageal ESD were enrolled as participants. These volunteers were then randomized into control group and experimental group - with an equal ratio of participants in each group. The novel gel was applied after the ESD procedure exclusively in the experimental group. This gel consisted of a fixative solution (calcium chloride) and a colloidal solution (poloxamers, sodium alginate, and beta-glucan).
In the control arm, volunteers solely received a standard esophageal ESD procedure. The key endpoint was healing rate. Participants were given instructions to promptly report any adverse events experienced on days 1, 14, and 30 after the ESD procedure. Additionally, a follow-up examination using endoscopy was conducted two weeks later to verify the healing progress of the wounds.
Among the 92 subjects enrolled for the study, 81 completed the trial. The experimental group demonstrated significantly higher healing rates compared to the control group, as depicted in Table 1:
Throughout the follow-up period, no severe adverse events were reported by the volunteers.
The application of this newly developed gel in daily clinical practice is strongly recommended as it has been demonstrated to conveniently, effectively, and safely accelerate the healing process of wounds resulting from esophageal ESD.
Scientific Reports
A new protective gel to facilitate ulcer healing in artificial ulcers following oesophageal endoscopic submucosal dissection: a multicentre, randomized trial
Tianyu Zhou et al.
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