Dennis M Jensen1, Thomas Kovacs2, Kevin A Ghassemi2, Marc Kaneshiro2, Jeffrey Gornbein3. 1. 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. 2. 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. 3. 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.
Abstract
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).
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).
Authors: Dennis M Jensen; Gordon V Ohning; Thomas O G Kovacs; Kevin A Ghassemi; Rome Jutabha; Gareth S Dulai; Gustavo A Machicado Journal: Gastrointest Endosc Date: 2015-08-28 Impact factor: 9.427
Authors: Joseph Jy Sung; Philip Wy Chiu; Francis K L Chan; James Yw Lau; Khean-Lee Goh; Lawrence Hy Ho; Hwoon-Young Jung; Jose D Sollano; Takuji Gotoda; Nageshwar Reddy; Rajvinder Singh; Kentaro Sugano; Kai-Chun Wu; Chun-Yin Wu; David J Bjorkman; Dennis M Jensen; Ernst J Kuipers; Angel Lanas Journal: Gut Date: 2018-04-24 Impact factor: 23.059
Authors: Dennis M Jensen; Alan Barkun; David Cave; Ian M Gralnek; Rome Jutabha; Loren Laine; James Y W Lau; John R Saltzman; Roy Soetikno; Joseph J Y Sung Journal: Aliment Pharmacol Ther Date: 2021-07-20 Impact factor: 9.524