Introduction
Endoscopic submucosal dissection (ESD) is widely established as a curative treatment for gastric epithelial neoplasms in Japan. However, post-ESD bleeding remains one of the major adverse events, occurring in approximately 5% of cases. The risk is substantially higher, reported about 10-20% of patients receiving dual antiplatelet therapy (DAPT) or anticoagulants, including warfarin and direct oral anticoagulants (DOACs), and more effective preventive strategies are needed for these high-risk patients. Shielding of post-ESD ulcers with polyglycolic acid (PGA) sheets fixed with fibrin glue has recently been reported as a potential preventive method 1,2).
Aims & Methods
This multicenter prospective study aimed to evaluate the efficacy and safety of PGA sheet and fibrin glue shielding in patients undergoing gastric ESD while receiving anticoagulants or DAPT.
Between October 26, 2020 and March 5, 2025, 130 patients undergoing gastric ESD for gastric epithelial neoplasms were enrolled. After exclusion of 5 patients who discontinued the study, 125 patients were included in the analysis. In all patients, the post-ESD ulcer was endoscopically covered with a PGA sheet (Neoveil® NV-M-015G) and fibrin glue (Beriplast® P). The primary endpoint was the incidence of delayed bleeding within 28 days after ESD. Secondary endpoints included late-phase bleeding (days 7-28), bleeding rates according to antithrombotic regimen, procedure-related adverse events, and risk factors for delayed bleeding. The full analysis set (FAS) was used for the primary analysis, the per-protocol set (PPS) for supportive analysis, and the safety analysis set for safety evaluation. Based on previous reports and clinical relevance, the threshold delayed bleeding rate was set at 15%.
Results
Among the 125 patients analyzed, the mean age was 77.2 years and 96 patients (76.8%) were male. The preoperative diagnoses were gastric adenoma in 24 patients (19.2%), suspected early gastric cancer in 18 (14.4%), and early gastric cancer in 83 (66.4%). The mean tumor size was 16.4 mm. Regarding antithrombotic therapy, 7 patients (5.6%) received DAPT, 111 (88.8%) received DOACs, and 7 (5.6%) received warfarin. Among DOAC users, 47 received edoxaban, 7 dabigatran, 31 rivaroxaban, and 26 apixaban. In the FAS analysis, delayed bleeding occurred in 13 of 125 patients (10.4%; 95% confidence interval [CI], 5.7%-17.1%), with a one-sided p value of 0.0899. In the PPS analysis, delayed bleeding occurred in 12 of 123 patients (9.8%; 95% CI, 5.1%-16.4%), with a one-sided p value of 0.0608.
Conclusion
This prospective multicenter study evaluated PGA sheet and fibrin glue shielding in patients at high risk of post-ESD bleeding due to anticoagulant use or DAPT. Although the delayed bleeding rate was below the prespecified threshold of 15%, statistical significance was not achieved. The observed bleeding rate was numerically lower than previously reported rates in similar high-risk populations, suggesting that this shielding method may be a promising preventive strategy. Further controlled studies are warranted.
References
- Tsuji, Yosuke, et al. "Polyglycolic acid sheets and fibrin glue decrease the risk of bleeding after endoscopic submucosal dissection of gastric neoplasms (with video)." Gastrointestinal endoscopy 81.4 (2015): 906-912.
- Kataoka, Yosuke, et al. "Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial." Endoscopy 51.07 (2019): 619-627.
Disclosure
Yosuke Tsuji, Male, Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan: Study grant from GUNZE.
Others: Nothing to disclosure.