Leading experts in the field of digestive endoscopy gather to jointly explore the issue of artificial ulcers following ESD procedures. July 21, 2019

　　—— Highlights from the RuiLaiSheng Clinical Study Protocol Discussion Meeting

　　On July 21, 2019, a clinical research meeting—organized and led by Beijing Tsinghua Changgeng Hospital, Affiliated to Tsinghua University, with Boda Weiye serving as the sponsor—was grandly held in the conference room on the 22nd floor of the Crowne Plaza Lido Hotel in Beijing. The meeting focused on discussing the clinical trial protocol for using RelaSheng in combination with PPI (proton pump inhibitors) to treat artificial ulcers following endoscopic submucosal dissection (ESD). This clinical study is set to be conducted across 10 leading digestive endoscopy centers nationwide, with an anticipated total enrollment of 200 participants.

　　This meeting revolved around the experimental research plan, delving into key issues related to artificial ulcers following ESD procedures. It laid the groundwork for launching a multi-center clinical study aimed at further validating the efficacy and safety of Relaisheng combined with esomeprazole in treating post-ESD ulcers. At the same time, the discussion advanced efforts to identify the optimal drug regimen and treatment duration for managing gastric ulcers after ESD, while also providing more evidence-based medical support for pharmacological interventions targeting this condition among China's population. The conference concluded successfully.

　　The clinical trial protocol discussion meeting was opened with a speech by Professor Jiang Bo, the meeting chair. He noted that with the advancement and widespread application of endoscopic techniques, the detection rate of early gastrointestinal tumors has significantly improved. Numerous studies have demonstrated that endoscopic treatment for patients with early-stage gastrointestinal tumors can achieve outcomes comparable to those of surgical intervention. ESD offers advantages such as minimal invasiveness and rapid postoperative recovery, while also minimizing the risk of residual lesions and recurrence. However, the management and treatment of large artificial ulcers left behind after extensive lesion removal cannot be overlooked. Current research suggests that combining PPIs with mucosal protectants can produce a notable synergistic effect; yet, existing studies exhibit considerable heterogeneity. As a result, the optimal treatment strategy for post-ESD artificial ulcers remains highly controversial. Enhancing the healing quality of these postoperative ulcers and reducing related complications are critical factors influencing patient prognosis—and they also represent both the responsibility and the ongoing challenge faced by clinicians specializing in endoscopy. This, in fact, is precisely the original intention and significance behind launching this clinical study.

　　Mr. Xie Wenbo, the General Manager, provided a detailed introduction to all the distinguished guests present, outlining BoDa Weiye Company’s overview, as well as Ruilai Sheng’s early-stage clinical research that has already been initiated and completed, and the company’s future product positioning and research directions.

　　Professor Du Shiyu from the China-Japan Friendship Hospital in Beijing provided an interpretation of the "Perioperative Guidelines for Endoscopic Submucosal Dissection of the Stomach," delivering an academic presentation focused on medication management following gastric ESD procedures. Professor Du noted that iatrogenic ulcers are an inevitable complication after ESD, often leading to a range of adverse events such as pain, bleeding, and even perforation. Persistent ulcers in patients who have undergone ESD not only increase the risk of delayed bleeding but also contribute to ongoing upper abdominal discomfort. Therefore, these complications should receive due attention, making pharmacological management of iatrogenic ulcers post-ESD particularly crucial. Meta-analyses have demonstrated that combining PPIs with gastric mucosal protectants after ESD significantly enhances ulcer healing rates compared to PPI monotherapy alone. Meanwhile, numerous authoritative guidelines—both domestically and internationally—have clearly recognized the therapeutic value and established the role of mucosal protectants in treating such ulcers.

　　Professor Sun Zhen from Jilin City People's Hospital elaborated on the pathophysiological processes of wound repair and the factors influencing ulcer healing, highlighting the mechanisms by which polyprone zinc—a chelate of L-carnosine and zinc—promotes healing. These mechanisms include stimulating mucus secretion, exerting antioxidant effects, stabilizing cell membranes, and inducing the production of heat shock proteins (HSPs) as well as heme oxygenase-1 (HO-1). Additionally, he shared insights from his hospital’s exemplary clinical cases, affirming both the rationale behind this clinical study and its promising future prospects.

　　Experts attending the conference spoke freely, sharing in a rich feast of academic ideas and intellectual exchange. The meeting delved deeply into the current issues and challenges surrounding post-ESD management of artificial ulcers, while also conducting multi-faceted, multi-perspective analyses of the therapeutic benefits offered by mucosal protectants—providing fresh insights into the treatment of artificial ulcers following ESD procedures.

　　Finally, all the participating experts engaged in an in-depth discussion on the key issues involved in this clinical trial, including the procurement and management of the investigational drug, the dosing regimen, disease diagnostic criteria, inclusion and exclusion criteria, trial grouping, collection of primary and secondary efficacy endpoints, measurement and evaluation of efficacy indicators, as well as the quantitative grading standards. Ms. Li Mingru, the representative from the sponsor, meticulously documented the experts' recommendations and subsequently refined the study protocol accordingly. Regarding the statistical aspects of the research plan, Ms. Li Mingru consulted Professor Zhang Xiaofei, a renowned domestic expert in clinical epidemiology and biostatistics, after the meeting.

　　This meeting focused on the clinical trial study protocol and conducted an in-depth discussion on artificial ulcer-related issues following ESD procedures. It laid the groundwork for initiating a multi-center clinical study aimed at further validating the efficacy and safety of Relaisheng combined with esomeprazole in treating post-ESD ulcers, while also advancing the exploration of optimal treatment regimens and durations for pharmacological management of gastric ulcers in China's population after ESD.