Edmund J Bini1, Jonathan Cohen. 1. Division of Gastroenterology, VA New York Harbor Healthcare System, New York, New York 10010, USA.
Abstract
BACKGROUND: Two recent randomized, controlled trials have demonstrated efficacy for combination endoscopic therapy in the management of bleeding peptic ulcer with adherent clot. The aim of this study was to determine the effectiveness of this technique in a clinical practice setting. METHODS:Medical records of consecutive patients, seen from January 1992 through December 1999, with severe ulcer hemorrhage and non-bleeding adherent clots resistant to target irrigation were reviewed. The decision for combination endoscopic therapy (epinephrine injection, removal of adherent clot, treatment of underlying stigmata) or medical therapy was left to the discretion of the endoscopist. RESULTS: Of 244 patients with adherent clots, 138 (56.6%) had endoscopic therapy and 106 (43.4%) were managed with medical therapy alone. The baseline characteristics of the two groups were similar, except for older age in the endoscopic therapy group. Recurrence of bleeding within 7 days of endoscopy was significantly less frequent in the endoscopic therapy group than the medical therapy group (respectively, 8.7% vs. 27.4%; adjusted odds ratio 0.07 95% CI [0.02, 0.22], p<0.001). Median hospital stay (6.0 vs. 8.0 days; p<0.001), median number of red blood cell transfusions after endoscopy (2.0 vs. 3.0 units; p=0.01), the need for repeat endoscopy (9.4% vs. 26.4%; p<0.001), and recurrent bleeding within 30 days (10.1% vs. 28.3%; p<0.001) were significantly lower in the endoscopic therapy group. In addition, the need for ulcer surgery (5.8% vs. 9.4%; p=0.28) and 30-day mortality (3.6% vs. 7.5%; p=0.18) were lower in the endoscopic therapy group, although these differences were not statistically significant. Endoscopic complications were uncommon (1.4% vs. 0.9%; p=1.00). CONCLUSIONS: Combination endoscopic treatment of ulcers with an adherent clot was associated with a significant reduction in recurrent ulcer hemorrhage compared with medical therapy alone. These findings confirm that the efficacy of combination endoscopic therapy demonstrated in carefully designed, randomized, controlled clinical trials can be reproduced when this technique is applied in a clinical practice setting. However, combination therapy did not significantly reduce the need for ulcer surgery or 30-day mortality.
RCT Entities:
BACKGROUND: Two recent randomized, controlled trials have demonstrated efficacy for combination endoscopic therapy in the management of bleeding peptic ulcer with adherent clot. The aim of this study was to determine the effectiveness of this technique in a clinical practice setting. METHODS: Medical records of consecutive patients, seen from January 1992 through December 1999, with severe ulcer hemorrhage and non-bleeding adherent clots resistant to target irrigation were reviewed. The decision for combination endoscopic therapy (epinephrine injection, removal of adherent clot, treatment of underlying stigmata) or medical therapy was left to the discretion of the endoscopist. RESULTS: Of 244 patients with adherent clots, 138 (56.6%) had endoscopic therapy and 106 (43.4%) were managed with medical therapy alone. The baseline characteristics of the two groups were similar, except for older age in the endoscopic therapy group. Recurrence of bleeding within 7 days of endoscopy was significantly less frequent in the endoscopic therapy group than the medical therapy group (respectively, 8.7% vs. 27.4%; adjusted odds ratio 0.07 95% CI [0.02, 0.22], p<0.001). Median hospital stay (6.0 vs. 8.0 days; p<0.001), median number of red blood cell transfusions after endoscopy (2.0 vs. 3.0 units; p=0.01), the need for repeat endoscopy (9.4% vs. 26.4%; p<0.001), and recurrent bleeding within 30 days (10.1% vs. 28.3%; p<0.001) were significantly lower in the endoscopic therapy group. In addition, the need for ulcer surgery (5.8% vs. 9.4%; p=0.28) and 30-day mortality (3.6% vs. 7.5%; p=0.18) were lower in the endoscopic therapy group, although these differences were not statistically significant. Endoscopic complications were uncommon (1.4% vs. 0.9%; p=1.00). CONCLUSIONS: Combination endoscopic treatment of ulcers with an adherent clot was associated with a significant reduction in recurrent ulcer hemorrhage compared with medical therapy alone. These findings confirm that the efficacy of combination endoscopic therapy demonstrated in carefully designed, randomized, controlled clinical trials can be reproduced when this technique is applied in a clinical practice setting. However, combination therapy did not significantly reduce the need for ulcer surgery or 30-day mortality.