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Low-dose PPI to prevent bleeding after ESD: A multicenter randomized controlled study - 19/02/21

Doi : 10.1016/j.biopha.2021.111251 
Li Yang a, Jian Qi b, Weiqing Chen c, Qinghong Guo d, Rui Xie e, Zhifeng Zhao f, Shanyu Qin g, Aiming Liu h, Mingming Den i, Chaoqiang Fan a, Jianyin Bai a, Hui Lin j, Hong Guo a, , Shiming Yang a,
a Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, China 
b Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Hubei, China 
c Department of Gastroenterology, Chongqing University Cancer Hospital, Chongqing, China 
d Department of Gastroenterology, the First Hospital of Lanzhou University, Gansu, China 
e Department of Gastroenterology, Affiliated Hospital of Zunyi Medical University, Guizhou, China 
f Department of Gastroenterology, the Fourth Affiliated Hospital of China Medical University, Liaoning, China 
g Department of Gastroenterology, the First Affiliated Hospital of Guangxi Medical University, Guangxi, China 
h Department of Gastroenterology, Fuling Central Hospital, Chongqing, China 
i Department of Gastroenterology, the Affiliated Hospital of Southwest Medical University, Sichuan, China 
j Department of Epidemiology, Army Medical University, Chongqing, China 

Corresponding authors at: Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, 40037, China.Department of GastroenterologyXinqiao Hospital of Army Medical UniversityChongqing40037China

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Graphical abstract




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Highlights

This multi-center RCT will provide evidence for the rational application of PPI in ESD.
Low-dose PPIs were sufficient for prevention post-ESD bleeding and its efficacy level was equivalent to high dose PPIs.
Artificial ulcer healing after ESD in low-dose PPIs was similar to high dose PPIs.

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Abstract

Background

Although proton pump inhibitors (PPIs) are widely used in the prevention of gastric bleeding caused by endoscopic submucosal dissection (ESD), there is no consensus on the optimal regimen for these patients. Therefore, we aim to investigate whether intermittent use of low-dose PPI is sufficient to prevent post-ESD bleeding.

Methods

This multicenter, non-inferiority, randomized controlled trial was conducted at 9 hospitals in China. Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment were randomly assigned (1:1) to receive either intermittent low-dose or continuous high-dose PPIs treatment. After three days, all patients administered orally esomeprazole 40 mg once a day for 8 weeks. The primary endpoint was post-ESD bleeding within 7 days. Analysis was done according to the intention-to-treat principle with the non-inferiority margin (Δ) of 5%.

Results

526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414 were randomly assigned to low-dose (n = 209) or high-dose (n = 205) esomeprazole treatment group without dropouts within7 days. The total post-ESD bleeding is occurred in 13 (6.2 %, 95 % CI 3.3–9.6) of 209 within 7 days in the intermittent low-dose group, and 12 (5.9 %, 95 % CI 2.9–9.3) of 205 in the continuous high-dose group. The absolute risk reduction (ARR) was 0.4 % (−4.2, 4.9). One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005).

Conclusion

The intermittent use of low-dose PPIs is sufficient to prevent post-ESD bleeding. It might be applied in clinical practice to prevent post-ESD bleeding and reduce the costs related to PPIs.

El texto completo de este artículo está disponible en PDF.

Keywords : Proton pump inhibitor (PPI), Endoscopic submucosal dissection (ESD), Post ESD bleeding, ESD-related ulcer, Randomized, controlled clinical trial


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© 2021  The Author(s). Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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