Abstract
Background and Study Aims: A controlled and randomized multicenter study was carried out in order to compare
the efficacy of fibrin sealant and Nd:YAG laser photocoagulation in patients with
high-risk arterial bleeding from peptic ulcers of the stomach and the small intestine.
Patients and Methods: In four teaching hospitals, 53 patients presenting with either active arterial ulcer
bleeding (Forrest class 1 a) or a large visible vessel in the ulcer base (diameter
over 2 mm, Forrest class 2 a) were treated with infiltration of epinephrine 1:10,000
followed by the injection of fibrin tissue adhesive (n = 28), or with epinephrine
plus laser photocoagulation (n = 25). Permanent hemostasis for at least seven days
served as the principal end point; rebleeding, emergency surgery, and hospital mortality
served as further end points.
Results: There were no significant differences between the study groups in terms of age, risk
factors, initial hemoglobin values, number of patients showing signs of hemodynamic
impairment, ulcer size and localization, or bleeding activity. Primary hemostasis
was achieved in all patients. Rebleeding rates were seven of 28 and four of 25 among
the patients treated with fibrin sealant and laser coagulation, respectively (not
significant). There were no significant differences regarding the rates of ultimate
hemostasis (24 of 28 vs. 24 of 25), emergency surgery (four of 28 vs. one of 25),
or hospital mortality (0 vs. two of 25). No complications occurred with either form
of treatment. Patients who had a visible vessel in the ulcer floor at the first control
endoscopy had a significantly higher incidence of rebleeding, regardless of the type
of endoscopic therapy.
Conclusions: We conclude that both the injection of fibrin tissue adhesive and laser photocoagulation
are effective methods of treating high-risk arterial peptic ulcer bleeding. As the
number of high-risk patients necessary to reach significance are difficult to recruit
within a reasonable period even in a multicenter study, a new meta-analysis of all
studies now available should be considered.