PMID- 32828873
OWN - NLM
STAT- MEDLINE
DCOM- 20211110
LR  - 20221102
IS  - 1542-7714 (Electronic)
IS  - 1542-3565 (Print)
IS  - 1542-3565 (Linking)
VI  - 19
IP  - 11
DP  - 2021 Nov
TI  - Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe 
      Nonvariceal Upper Gastrointestinal Bleeding.
PG  - 2315-2323.e2
LID - S1542-3565(20)31155-1 [pii]
LID - 10.1016/j.cgh.2020.08.046 [doi]
AB  - BACKGROUND AND AIMS: No prior randomized controlled trial (RCT) has reported 
      patient outcomes of large over-the-scope clip (OTSC) compared to standard 
      hemostasis as initial endoscopic treatment of severe NVUGIB. This was our study 
      aim. METHODS: Patients with bleeding ulcers or Dieulafoy's lesions and major 
      stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) 
      - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by 
      Doppler probe) were randomized to OTSC or standard endoscopic hemostasis (with 
      hemoclips or multipolar electrocoagulation - MPEC). Patients and their healthcare 
      providers were blinded to treatments and made all post-randomization management 
      decisions. Ulcer patients received high dose intravenous infusions of proton pump 
      inhibitors (PPI) for 3 days, then 27 days of oral PPI. 30 day outcomes were 
      prospectively recorded; data management was with SAS; and data analysis was by a 
      statistician. RESULTS: 53 patients (25 OTSC, 28 Standard) were randomized, with 
      similar baseline risk factors. However, there were significant differences in 
      OTSC vs. Standard groups in rates of rebleeding (4% vs. 28.6%; p = .017; relative 
      risk 0.10, 95% confidence intervals 0.01, 0.91; number needed to treat 4); severe 
      complications (0 % vs. 14.3%); and post-randomization units of red cell 
      transfusions (0.04 vs. 0.68). All rebleeds occurred in patients with major SRH 
      and none with lesser SRH. CONCLUSION: 1. OTSC significantly reduced rates of 
      rebleeding, severe complications, and post-randomization red cell transfusions. 
      2. Patients with major stigmata benefited significantly from hemostasis with 
      OTSC, but those with lesser stigmata did not. (ClinicalTrials.gov, Number: 
      NCT03065465).
CI  - Copyright (c) 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.
FAU - Jensen, Dennis M
AU  - Jensen DM
AD  - CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald 
      Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University 
      of California, Los Angeles, Los Angeles, California; West Los Angeles Veterans 
      Administration Medical Center, Los Angeles, California. Electronic address: 
      djensen@mednet.ucla.edu.
FAU - Kovacs, Thomas
AU  - Kovacs T
AD  - CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald 
      Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University 
      of California, Los Angeles, Los Angeles, California.
FAU - Ghassemi, Kevin A
AU  - Ghassemi KA
AD  - CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald 
      Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University 
      of California, Los Angeles, Los Angeles, California.
FAU - Kaneshiro, Marc
AU  - Kaneshiro M
AD  - CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald 
      Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University 
      of California, Los Angeles, Los Angeles, California.
FAU - Gornbein, Jeffrey
AU  - Gornbein J
AD  - Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, 
      University of California, Los Angeles, Los Angeles, California; Department of 
      Medical Statistics Core, Division of General Internal Medicine, Department of 
      Medicine, David Geffen School of Medicine at UCLA, University of California, Los 
      Angeles, Los Angeles, California.
LA  - eng
SI  - ClinicalTrials.gov/NCT03065465
GR  - P30 DK041301/DK/NIDDK NIH HHS/United States
GR  - T32 DK007180/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20200820
PL  - United States
TA  - Clin Gastroenterol Hepatol
JT  - Clinical gastroenterology and hepatology : the official clinical practice journal 
      of the American Gastroenterological Association
JID - 101160775
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
CIN - Clin Gastroenterol Hepatol. 2021 Dec;19(12):2678-2679. PMID: 33338658
CIN - Clin Gastroenterol Hepatol. 2021 Nov;19(11):2266-2269. PMID: 33346139
CIN - Clin Gastroenterol Hepatol. 2021 Dec;19(12):2679-2680. PMID: 33465481
MH  - Gastrointestinal Hemorrhage/therapy
MH  - *Hemostasis, Endoscopic
MH  - Humans
MH  - Proton Pump Inhibitors
MH  - Surgical Instruments
MH  - Treatment Outcome
PMC - PMC7895857
MID - NIHMS1624008
OTO - NOTNLM
OT  - Dieulafoy's Lesion
OT  - Hemoclips
OT  - Nonvariceal UGI Hemorrhage
OT  - Ulcer Bleeding
EDAT- 2020/08/24 06:00
MHDA- 2021/11/11 06:00
PMCR- 2022/11/01
CRDT- 2020/08/24 06:00
PHST- 2020/07/20 00:00 [received]
PHST- 2020/08/13 00:00 [revised]
PHST- 2020/08/17 00:00 [accepted]
PHST- 2020/08/24 06:00 [pubmed]
PHST- 2021/11/11 06:00 [medline]
PHST- 2020/08/24 06:00 [entrez]
PHST- 2022/11/01 00:00 [pmc-release]
AID - S1542-3565(20)31155-1 [pii]
AID - 10.1016/j.cgh.2020.08.046 [doi]
PST - ppublish
SO  - Clin Gastroenterol Hepatol. 2021 Nov;19(11):2315-2323.e2. doi: 
      10.1016/j.cgh.2020.08.046. Epub 2020 Aug 20.