Prospective trial of endoscopic clips versus combination therapy in upper GI bleeding (PROTECCT--UGI bleeding).

BACKGROUND: It is not known if combination therapy of epinephrine injection and multipolar electrocoagulation or hemoclips are a more efficient or effective treatment for patients with acute nonvariceal upper gastrointestinal (GI) bleeding.

METHODS: Adult patients with active nonvariceal upper GI bleeding, a nonbleeding visible vessel, or after removal of an adherent clot findings of active bleeding or a visible vessel were studied. Patients were randomized to either therapy and the outcomes were assessed at 30 days.

RESULTS: Forty-seven patients were studied: 26 patients randomized to hemoclips and 21 to combination therapy. There were 22 patients with active bleeding, 13 with a nonbleeding visible vessel, and 12 with an adherent clot. The median duration of endoscopic therapy was 17 min in the hemoclip group versus 20 min for the combination therapy, p= 0.29. Primary hemostasis with successful initial control of bleeding occurred in 26 (100%) of 26 hemoclip patients and 20 (95.2%) of 21 combination therapy patients, p= 0.45. The rebleeding rates were: 4 (15.4%) of 26 hemoclip patients versus 5 (23.8%) of 21 combination therapy patients, p= 0.49. Overall, the length of hospital stay, units of blood transfused, surgery rates, and mortality were not different.

CONCLUSIONS: In this prospective, randomized controlled trial of endoscopic hemoclips versus combination therapy in the nonvariceal upper GI bleeding, the efficiency, efficacy, and complications of the two treatment modalities were not significantly different.