Comparison of hemostatic forceps with soft coagulation versus argon plasma coagulation for bleeding peptic ulcer--a randomized trial.

BACKGROUND AND STUDY AIMS: Endoscopic high-frequency soft coagulation is used to manage visible bleeding or nonbleeding vessels during endoscopic submucosal dissection. The aim of the present study was to compare the efficacy of hemostasis by soft coagulation (using hemostatic forceps) with argon plasma coagulation (APC), in a prospective randomized trial. PATIENTS AND METHODS: From January 2013 to June 2014, 276 patients were randomly assigned into two groups: epinephrine injection plus APC (the APC group); or epinephrine injection plus soft coagulation using hemostatic forceps (the HFSC group). As the primary outcome we compared recurrent bleeding rates within 30 days after initial hemostasis in a noninferiority design.
RESULTS: After exclusion, 75 patients in the APC group and 76 in the HFSC group were finally evaluated. In the APC group 72 patients (96 %) were successfully treated with the assigned treatment alone vs. 73 (96 %) in the HFSC group. Initial endoscopic hemostasis using a single or combined modality was achieved in all patients. Recurrent bleeding within 30 days was experienced by five patients (6.7 %) and seven patients (9.2 %) in the AFC and HFSC groups, respectively (P = 0.563), and within 7 days by three patients (4.0 %) and five patients (6.6 %), respectively (P = 0.719). We found no significant difference in the rates of adverse events (1.3 % vs. 2.6 %) or mortality (2.7 % vs. 2.6 %) between the groups.
CONCLUSIONS: The efficacy and safety of soft coagulation using endoscopic hemostatic forceps is not inferior to APC when used to treat patients with bleeding peptic ulcers. Clinicaltrials.gov NCT02020603. © Georg Thieme Verlag KG Stuttgart · New York.

RCT Entities:   Population Interventions Outcomes