OBJECTIVE: One of the major challenges in peptic ulcer bleeding (PUB) is rebleeding which is associated with up to a fivefold increase in mortality. We examined if supplementary transcatheter arterial embolization (STAE) performed after achieved endoscopic hemostasis improves outcome in patients with high-risk ulcers. MATERIAL AND METHODS: The study was designed as a non-blinded, parallel group, randomized-controlled trial and performed in a university hospital setting. Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized (1:1 ratio) to STAE of the bleeding artery within 24 h or continued standard treatment. Randomization was stratified according to stigmata of hemorrhage. Patients were followed for 30 days. Primary outcome was a composite endpoint where patients were classified into five groups based on transfusion requirement, development of rebleeding, need of hemostatic intervention and mortality. Secondary outcomes were rebleeding, number of blood transfusions received, duration of admission and mortality. RESULTS:Totally 105 patients were included. Of the 49 patients allocated to STAE 31 underwentsuccessful STAE. There was no difference in composite endpoint. Two versus eight patients re-bled in the STAE and control group, respectively (Intention-to-treat analysis; p = .10). After adjustment for possible imbalances a strong trend was noted between STAE and rate of rebleeding (p = .079). CONCLUSIONS:STAE is potentially useful for preventing rebleeding in high-risk PUB. STAE can safely be performed in selected cases with high risk of rebleeding. Further studies are needed in order to confirm these findings; ClincialTrials.gov number, NCT01125852.
RCT Entities:
OBJECTIVE: One of the major challenges in peptic ulcer bleeding (PUB) is rebleeding which is associated with up to a fivefold increase in mortality. We examined if supplementary transcatheter arterial embolization (STAE) performed after achieved endoscopic hemostasis improves outcome in patients with high-risk ulcers. MATERIAL AND METHODS: The study was designed as a non-blinded, parallel group, randomized-controlled trial and performed in a university hospital setting. Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized (1:1 ratio) to STAE of the bleeding artery within 24 h or continued standard treatment. Randomization was stratified according to stigmata of hemorrhage. Patients were followed for 30 days. Primary outcome was a composite endpoint where patients were classified into five groups based on transfusion requirement, development of rebleeding, need of hemostatic intervention and mortality. Secondary outcomes were rebleeding, number of blood transfusions received, duration of admission and mortality. RESULTS: Totally 105 patients were included. Of the 49 patients allocated to STAE 31 underwent successful STAE. There was no difference in composite endpoint. Two versus eight patients re-bled in the STAE and control group, respectively (Intention-to-treat analysis; p = .10). After adjustment for possible imbalances a strong trend was noted between STAE and rate of rebleeding (p = .079). CONCLUSIONS: STAE is potentially useful for preventing rebleeding in high-risk PUB. STAE can safely be performed in selected cases with high risk of rebleeding. Further studies are needed in order to confirm these findings; ClincialTrials.gov number, NCT01125852.
Authors: David M Ray; Indu Srinivasan; Shou-Jiang Tang; Andreas S Vilmann; Peter Vilmann; Timothy C McCowan; Akash M Patel Journal: World J Radiol Date: 2017-03-28
Authors: Antonio Tarasconi; Federico Coccolini; Walter L Biffl; Matteo Tomasoni; Luca Ansaloni; Edoardo Picetti; Sarah Molfino; Vishal Shelat; Stefania Cimbanassi; Dieter G Weber; Fikri M Abu-Zidan; Fabio C Campanile; Salomone Di Saverio; Gian Luca Baiocchi; Claudio Casella; Michael D Kelly; Andrew W Kirkpatrick; Ari Leppaniemi; Ernest E Moore; Andrew Peitzman; Gustavo Pereira Fraga; Marco Ceresoli; Ronald V Maier; Imtaz Wani; Vittoria Pattonieri; Gennaro Perrone; George Velmahos; Michael Sugrue; Massimo Sartelli; Yoram Kluger; Fausto Catena Journal: World J Emerg Surg Date: 2020-01-07 Impact factor: 5.469
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