A Randomized, Controlled Trial of Fibrin Glue to Prevent Bleeding after Gastric Endoscopic Submucosal Dissection
Lee HD, Lee E, Kim SG, Shin CM, Park JC, Choi KD, HahnSoo-Jeong Cho S
The American journal of gastroenterology. 2022
INTRODUCTION This study evaluated the efficacy of fibrin glue for preventing post-endoscopic submucosal dissection (ESD) bleeding in high-risk patients for bleeding (expected iatrogenic ulcer size ≥ 40 mm or receiving antithrombotic therapy). METHODS A multicenter, open-label, randomized controlled trial was performed at four tertiary-medical centers in Korea between July 1, 2020, and June 22, 2022. Patients with gastric neoplasm and a high risk of post-ESD bleeding were enrolled and allocated at 1:1 to a control group (standard ESD) or a fibrin glue group (fibrin glue applied to iatrogenic ulcers after standard ESD). The primary outcome was overall bleeding events within 4 weeks. The secondary outcomes were acute bleeding (within 48 hours post-ESD) and delayed bleeding (48 hours to 4 weeks post-ESD). RESULTS In total, 254 patients were randomized and 247 patients were included in the modified intention-to-treat population (125 patients in the fibrin glue group, 122 patients in the control group). Overall bleeding events occurred in 12.0% (15/125) of the fibrin glue group and 13.1% (16/122) of the control group (p=0.791). Acute bleeding events were significantly less common in the fibrin glue group than in the control group (1/125 vs. 7/122, p=0.034). Delayed bleeding events occurred in 11.2% (14/125) of the fibrin glue group and 7.3% (9/122) in the control group (p=0.301). DISCUSSION This trial failed to show a preventive effect of fibrin glue on overall post-ESD bleeding in high-risk patients. However, the secondary outcomes suggest a potential sealing effect of fibrin glue during the acute period.
Reactive Oxygen Species Scavenger in Acute Intracerebral Hemorrhage Patients: A Multicenter, Randomized Controlled Trial
Kim M, Byun J, Chung Y, Lee SU, Park JE, Park W, Park JC, Ahn JS, Lee S
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BACKGROUND AND PURPOSE Patients with intracerebral hemorrhage (ICH) have oxidative stress. Oxidative stress contributes to the development and progression of perihematomal edema (PHE) in brain hemorrhage patients. We hypothesized that reactive oxygen species (ROS) scavengers might have a neuroprotective role in the acute period of patients with ICH. METHODS This prospective, multicenter, single-blind, randomized study was conducted between June 2017 and October 2019. Intracranial bleeding, including spontaneous ICH, secondary ICH due to vascular anomalies, venous thrombosis, neoplasms, or hemorrhagic infarction, were included in our study. These ROS scavengers were given for 14 days with a dose of N-acetylcysteine 2000 mg/d and selenium 1600 µg/d intravenously. Other patients received a placebo. The primary outcome was hemorrhage and PHE volume changes in 2-week follow-up computed tomography between ROS scavenger versus placebo groups. RESULTS In total, 448 patients were enrolled with 123 patients remaining after applying the inclusion and exclusion criteria. There were no significant differences in baseline characteristics between the ROS scavenger (n=57) and placebo (n=66) groups. No significant differences in baseline hematoma and PHE volumes were observed but 2 weeks follow-up computed tomography showed significant differences in PHE volume (21.90±17.63 versus 30.66±32.35, P<0.01) and PHE ratio (1.19±0.73 versus 2.05±1.27, P<0.01). Among clinical factors, time to reach target Richmond Agitation Sedation Scale (5.98 hours [95% CI, 4.82-7.241 versus 8.42 hours], [95% CI, 6.57-10.77], P<0.01) and the length of intensive care unit stays (6.46 days [95% CI, 2.38-10.55 versus 12.66 days], [95% CI, 8.47-16.85], P<0.01) were significantly shortened among patients who received ROS scavengers than among patients who did not receive ROS scavenger. CONCLUSIONS ROS scavenger showed a significantly reduced PHE volume, time to reach target Richmond Agitation Sedation Scale, and shortened length of intensive care unit stay in patients with acute ICH. Early and high doses of ROS scavengers in a combination regimen may have played a key role in obtaining a favorable outcome in our study.
Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trial
Jung DH, Moon HS, Park CH, Park JC
BACKGROUND : Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early post-ESD bleeding, especially in patients with a high risk of post-ESD bleeding. METHODS : This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for post-ESD bleeding were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be > 40 mm and those who were regularly taking antithrombotic agents were defined as high risk patients. Patients were randomly assigned to the PHP or control groups. RESULTS Between May 2017 and September 2018, 143 patients were enrolled (PHP group, 73; control group, 70). The total post-ESD bleeding rate was 6.3 % (PHP group, 5.5 % vs. control group, 7.1 %; P = 0.74). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor for post-ESD bleeding. In subgroup analysis excluding the patients who continued to take antithrombotic agents (n = 129) during ESD, the rate of post-ESD bleeding tended to be lower in the PHP group than in the control group (0 % vs. 6.3 %; P = 0.06). CONCLUSION : PHP did not demonstrate a significant effect on the prevention of post-ESD bleeding in this study. Further larger scale, randomized controlled trials are needed to confirm this.
Effect of scheduled second-look endoscopy on peptic ulcer bleeding: a prospective randomized multicenter trial
Park SJ, Park H, Lee YC, Choi CH, Jeon TJ, Park JC, Kim JH, Youn YH, Kim YJ, Kim JH, et al
Gastrointestinal Endoscopy. 2017;87((2):):457-465
BACKGROUND AND AIM This study aimed to investigate the effectiveness of scheduled second-look EGD with endoscopic hemostasis on peptic ulcer rebleeding and sought to identify the risk factors related to the need for second-look EGD. METHODS We prospectively randomized patients who had endoscopically confirmed bleeding peptic ulcer with stigmata of active bleeding, visible vessel, or adherent clot into 2 groups between August 2010 and January 2013. Hemoclip application or thermal coagulation, and/or epinephrine injection were allowed for initial endoscopic therapy. Same dosage of proton pump inhibitor was injected intravenously. The study group received scheduled second-look EGD 24 to 36 hours after the initial hemostasis, and further therapy was applied if endoscopic stigmata persisted, as above. Those patients who developed rebleeding underwent operation or radiologic intervention despite the additional endoscopic therapy. Outcome measures included rebleeding, amount of transfusion, duration of hospitalization, and mortality. RESULTS After initial endoscopic hemostasis, 319 eligible patients were randomized into two groups. Sixteen (10.1%) and nine (5.6%) patients developed rebleeding (p=0.132), respectively. There was also no difference in surgical intervention (0, 0% vs. 1, 0.6%, p>0.999) or radiologic intervention (3, 1.9% vs 2, 1.2%, p=0.683), median duration of hospitalization (6.0 vs 5.0 days, p=0.151), amount of transfusion (2.4+/-1.7 vs 2.2+/-1.6 units, p=0.276), and mortality (2, 1.3% vs 2, 1.2%, p>0.999) between the 2 groups. Multivariate analysis showed that grade 3-4 of endoscopists' estimation to successfulness of initial hemostasis, history of NSAID use, and larger amounts of blood transfusions (≥ four units of RBC) were the independent risk factors of rebleeding. CONCLUSIONS A single EGD with endoscopic hemostasis is not inferior to scheduled second-look endoscopy in terms of reduction in rebleeding rate of peptic ulcer bleeding. Repeat endoscopy would be helpful in the patients with unsatisfactory initial endoscopic hemostasis, use of NSAIDs, and larger amounts of transfused blood.