Overview
A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.
Description
This is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome is comparing the hemostatic rates of the devices. Secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.
Eligibility
Inclusion Criteria:
- The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
- The patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 Forrest classification 1a (Active spurting) 2.2 Forrest classification 1b (Active oozing) 2.3 Forrest classification 2a (Non-bleeding visible vessel; NBVV) 2.4 Forrest classification 2b (Adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel
Exclusion Criteria:
- Uncorrectable hemostasis laboratory including serum platelet < 50000 /mm3 or International Normalized Ratio (INR) >1.5
- Bleeding from cancerous gastroduodenal ulcer
- The patient with history of gastric surgery
- The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
- The patient with history of proton pump inhibitor allergy
- Pregnant
- The patient deny to participate in the study