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Comparison of a polysaccharide hemostatic powder and conventional therapy for peptic ulcer bleeding
Jung DH, Park CH, Choi SI, Kim HR, Lee M, Moon HS, Park JC
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2023
Abstract
BACKGROUND AND AIMS Hemostatic powders have been clinically used in the treatment of gastrointestinal bleeding. We investigated the non-inferiority of a polysaccharide hemostatic powder (PHP), compared with conventional endoscopic treatments, for peptic ulcer bleeding (PUB). METHODS This study was a prospective multicenter randomized open-label controlled trial at four referral institutions. We consecutively enrolled patients who had undergone emergency endoscopy for PUB. The patients were randomly assigned to either a PHP or conventional treatment group. In the PHP group, diluted epinephrine was injected, and the powder was applied as a spray. Conventional endoscopic treatment included the use of electrical coagulation or hemoclipping after injection of diluted epinephrine. RESULTS Between July 2017 and May 2021, 216 patients were enrolled in this study (PHP group, 105; control group, 111). Initial hemostasis was achieved in 92 of 105 patients (87.6%) in the PHP group and 96 of 111 patients (86.5%) in the conventional treatment group. Re-bleeding did not differ between the two groups. In subgroup analysis, the initial hemostasis failure rate in the conventional treatment group was 13.6% for Forrest IIa cases; however, there was no initial hemostasis failure in the PHP group (P=0.023). Large ulcer size (≥15mm) and chronic kidney disease with dialysis were independent risk factors for re-bleeding at 30 days. No adverse events were associated with PHP use. CONCLUSION PHP is not inferior to conventional treatments and could be of use in initial endoscopic treatment for PUB. Further studies are needed to confirm the re-bleeding rate of PHP (ClinicalTrials.gov 02717416).
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2.
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
Endoscopy. 2021;53(10):994-1002
Abstract
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.
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3.
Liberal versus restrictive transfusion strategy in critically ill oncologic patients: the Transfusion Requirements in Critically Ill Oncologic Patients randomized controlled trial
Bergamin FS, Almeida JP, Landoni G, Galas FR, Fukushima JT, Fominskiy E, Park CH, Osawa EA, Diz MP, Oliveira GQ, et al
Critical Care Medicine. 2017;45((5):):766-773
Abstract
OBJECTIVE To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. DESIGN Single center, randomized, double-blind controlled trial. SETTING Teaching hospital. PATIENTS Adult cancer patients with septic shock in the first 6 hours of ICU admission. INTERVENTIONS Patients were randomized to the liberal (hemoglobin threshold, < 9g/dL) or to the restrictive strategy (hemoglobin threshold, < 7g/dL) of RBC transfusion during ICU stay. MEASUREMENTS AND MAIN RESULTS Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). CONCLUSIONS We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.
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4.
The role of second-look endoscopy and prophylactic hemostasis after gastric endoscopic submucosal dissection: a systematic review and meta-analysis
Kim EH, Park SW, Nam E, Eun CS, Han DS, Park CH
Journal of Gastroenterology and Hepatology. 2016;32((4):):756-768
Abstract
BACKGROUND Although several studies have shown that second-look endoscopy does not affect the incidence of bleeding after gastric endoscopic submucosal dissection (ESD), the potential roles of second-look endoscopy have not been fully evaluated. We aimed to determine the role of second-look endoscopy after ESD through a systematic review and meta-analysis. METHODS We conducted a systematic literature search of MEDLINE, EMBASE, and the Cochrane Library through March 2016 using the keywords "second-look," "prophylactic hemostasis," "prophylactic haemostasis," "prevention," "prophylaxis," and "endoscopic submucosal dissection." Studies were included if they evaluated the incidence of post-ESD bleeding according to second-look endoscopy or prophylactic hemostasis during second-look endoscopy. RESULTS Four randomized controlled trials on post-ESD bleeding between second-look endoscopy and no second-look endoscopy and 12 non-randomized studies with a cohort design on post-ESD bleeding were included. On meta-analysis, second-look endoscopy did not affect delayed post-ESD bleeding (odds ratio [95% confidence interval] = 1.27 [0.80-2.00], I2 = 0%). During second-look endoscopy, patients who were considered as high-risk for post-ESD bleeding underwent prophylactic hemostasis. Delayed post-ESD bleeding was more common in patients who were treated with hemostasis during second-look endoscopy compared to those who were not (odds ratio [95% confidence interval] = 3.40 [1.87-6.18], I2 = 62%). In patients who underwent prophylactic hemostasis, number needed to prolong a hospitalization period to avoid one additional post-ESD bleeding after discharge was 25. CONCLUSION Second-look endoscopy after ESD could not reduce the risk of delayed post-ESD bleeding. Delayed post-ESD bleeding was more common in patients who underwent prophylactic hemostasis than in those who did not.
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5.
A prospective, randomized trial comparing mechanical methods of hemostasis plus epinephrine injection to epinephrine injection alone for bleeding peptic ulcer
Park CH, Joo YE, Kim HS, Choi SK, Rew JS, Kim SJ
Gastrointestinal Endoscopy. 2004;60((2)):173-9.
Abstract
BACKGROUND The hemostatic efficacy of mechanical methods of hemostasis, together with epinephrine injection, was compared with that of epinephrine injection alone in bleeding peptic ulcer. METHODS Ninety patients with a peptic ulcer with active bleeding or a non-bleeding visible vessel were randomly assigned to undergo a mechanical method of hemostasis (23 hemoclip application, 22 band ligation) plus epinephrine injection, or epinephrine injection alone. RESULTS The two groups were similar with respect to all background variables. Initial hemostasis was achieved in 44/45 (97.8%) patients in both groups. The mean number of hemoclips and elastic bands applied were 2.8: 95% CI[2.5, 3.1] and 1.1: 95% CI[1.0, 1.2], respectively, and the mean volume of epinephrine injected was 19.9 mL: 95% CI[19.3 mL, 20.5 mL]. The rate of recurrent bleeding in the combination group (2/44, 4.5%) was significantly lower in comparison with the injection group (9/44, 20.5%, p < 0.05). The mean number of therapeutic endoscopic sessions needed to achieve permanent hemostasis in the combination group (1.04: 95% CI[1.01, 1.07]) was significantly lower vs. the injection group (1.22: 95% CI[1.15, 1.30]). CONCLUSIONS The combination of an endoscopic mechanical method of hemostasis plus epinephrine injection is more effective than epinephrine injection alone for the treatment of bleeding peptic ulcer. RN YKH834O4BH (Epinephrine).