Arthur Schmidt1, Stefan Gölder2, Martin Goetz3, Alexander Meining4, James Lau5, Stefan von Delius6, Markus Escher7, Arthur Hoffmann8, Reiner Wiest9, Helmut Messmann2, Thomas Kratt2, Benjamin Walter4, Dominik Bettinger10, Karel Caca11. 1. Department of Gastroenterology, Klinikum Ludwigsburg, Ludwigsburg, Germany; Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany. 2. Department of Gastroenterology, Klinikum Augsburg, Augsburg, Germany. 3. Interdisciplinary Endoscopy, University of Tübingen, Tübingen, Germany. 4. Department of Gastroenterology, University of Ulm, Ulm, Germany. 5. Department of Surgery, University of Hong Kong, Hong Kong. 6. Department of Gastroenterology, Klinikum Rechts der Isar, TU München, München, Germany. 7. Department of Gastroenterology, Robert Bosch Krankenhaus Stuttgart, Stuttgart, Germany. 8. Department of Gastroenterology, Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany. 9. Department of Gastroenterology, Inselspital Bern, Bern, Switzerland. 10. Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Berta-Ottenstein-Programme, Faculty of Medicine, University of Freiburg, Freiburg, Germany. 11. Department of Gastroenterology, Klinikum Ludwigsburg, Ludwigsburg, Germany. Electronic address: karel.caca@kliniken-lb.de.
Abstract
BACKGROUND & AIMS:Endoscopic hemostasis is effective in treatment of bleeding peptic ulcers. However, rebleeding is difficult to treat and associated with substantial morbidity and mortality. We performed a prospective randomized trial to determine whether over-the-scope clips (OTSCs) are more effective than standard treatment of severe recurrent upper gastrointestinal bleeding. METHODS: We performed our study at 9 academic referral centers (in Germany, Switzerland, and Hong Kong) from March 2013 through September 2016. Adult patients with recurrent peptic ulcer bleeding following initially successful hemostasis (66 patients in the intent-to-treat analysis) were randomly assigned to groups (1:1) that underwent hemostasis with either OTSC or standard therapy. Standard therapy was defined as hemostasis with through-the-scope clips (TTSC, n = 31) or thermal therapy plus injection with diluted adrenaline (n = 2). The primary endpoint was further bleeding (a composite endpoint of a persistent bleeding despite endoscopic therapy according to the protocol or recurrent bleeding within 7 days after successful hemostasis). Patients with further bleeding were allowed to cross over to OTSC therapy. Main secondary endpoints were mortality, necessity of surgical or angiographic salvage therapy, duration of stay in the hospital or intensive care, number of blood units transfused, and complications associated with endoscopic therapy. RESULTS:Persistent bleeding after per-protocol hemostasis was observed in 14 patients (42.4%) in the standard therapy group and 2 patients (6.0%) in the OTSC group (P = .001). Recurrent bleeding within 7 days occurred in 5 patients (16.1%) in the standard therapy group vs 3 patients (9.1%) in the OTSC group (P = .468). Further bleeding occurred in 19 patients (57.6%) in the standard therapy group and in 5 patients (15.2%) in the OTSC group (absolute difference 42.4%; 95% confidence interval 21.6-63.2; P = .001) Within 30 days of follow-up, 1 patient in the standard therapy group (3.0%) and 1 patient in the OTSC group (3.0%) required surgical therapy (P = .999). Within 30 days of the procedure, 2 patients died in the standard therapy group (6.3%) and 4 patients died in the OTSC group (12.1%) (P = .672). There were no significant differences in the other secondary endpoints. CONCLUSIONS: In prospective randomized trial, we found endoscopic treatment with OTSCs to be superior to standard therapy with TTSCs for patients with recurrent peptic ulcer bleeding. STING Study, Clinicaltrials.gov no: NCT1836900.
RCT Entities:
BACKGROUND & AIMS: Endoscopic hemostasis is effective in treatment of bleeding peptic ulcers. However, rebleeding is difficult to treat and associated with substantial morbidity and mortality. We performed a prospective randomized trial to determine whether over-the-scope clips (OTSCs) are more effective than standard treatment of severe recurrent upper gastrointestinal bleeding. METHODS: We performed our study at 9 academic referral centers (in Germany, Switzerland, and Hong Kong) from March 2013 through September 2016. Adult patients with recurrent peptic ulcer bleeding following initially successful hemostasis (66 patients in the intent-to-treat analysis) were randomly assigned to groups (1:1) that underwent hemostasis with either OTSC or standard therapy. Standard therapy was defined as hemostasis with through-the-scope clips (TTSC, n = 31) or thermal therapy plus injection with diluted adrenaline (n = 2). The primary endpoint was further bleeding (a composite endpoint of a persistent bleeding despite endoscopic therapy according to the protocol or recurrent bleeding within 7 days after successful hemostasis). Patients with further bleeding were allowed to cross over to OTSC therapy. Main secondary endpoints were mortality, necessity of surgical or angiographic salvage therapy, duration of stay in the hospital or intensive care, number of blood units transfused, and complications associated with endoscopic therapy. RESULTS: Persistent bleeding after per-protocol hemostasis was observed in 14 patients (42.4%) in the standard therapy group and 2 patients (6.0%) in the OTSC group (P = .001). Recurrent bleeding within 7 days occurred in 5 patients (16.1%) in the standard therapy group vs 3 patients (9.1%) in the OTSC group (P = .468). Further bleeding occurred in 19 patients (57.6%) in the standard therapy group and in 5 patients (15.2%) in the OTSC group (absolute difference 42.4%; 95% confidence interval 21.6-63.2; P = .001) Within 30 days of follow-up, 1 patient in the standard therapy group (3.0%) and 1 patient in the OTSC group (3.0%) required surgical therapy (P = .999). Within 30 days of the procedure, 2 patients died in the standard therapy group (6.3%) and 4 patients died in the OTSC group (12.1%) (P = .672). There were no significant differences in the other secondary endpoints. CONCLUSIONS: In prospective randomized trial, we found endoscopic treatment with OTSCs to be superior to standard therapy with TTSCs for patients with recurrent peptic ulcer bleeding. STING Study, Clinicaltrials.gov no: NCT1836900.
Authors: Armin Kuellmer; Juliane Behn; Benjamin Meier; Andreas Wannhoff; Dominik Bettinger; Robert Thimme; Karel Caca; Arthur Schmidt Journal: United European Gastroenterol J Date: 2019-09-25 Impact factor: 4.623
Authors: Dennis M Jensen; Thomas Kovacs; Kevin A Ghassemi; Marc Kaneshiro; Jeffrey Gornbein Journal: Clin Gastroenterol Hepatol Date: 2020-08-20 Impact factor: 11.382
Authors: Alan N Barkun; Majid Almadi; Ernst J Kuipers; Loren Laine; Joseph Sung; Frances Tse; Grigorios I Leontiadis; Neena S Abraham; Xavier Calvet; Francis K L Chan; James Douketis; Robert Enns; Ian M Gralnek; Vipul Jairath; Dennis Jensen; James Lau; Gregory Y H Lip; Romaric Loffroy; Fauze Maluf-Filho; Andrew C Meltzer; Nageshwar Reddy; John R Saltzman; John K Marshall; Marc Bardou Journal: Ann Intern Med Date: 2019-10-22 Impact factor: 25.391
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