Prevention of rebleeding after primary haemostasis using haemostatic powder in non-variceal upper gastrointestinal bleeding: a multicentre randomised controlled trial

Abstract

Background: Non-variceal upper gastrointestinal bleeding (NVUGIB) remains a major cause of morbidity and mortality. Rebleeding rates following endoscopic treatment can reach up to 25% within 72 hours in patients with high-risk lesions.

Objective: To evaluate the efficacy of a haemostatic powder (Nexpowder) in reducing rebleeding rates after conventional endoscopic treatment in patients with NVUGIB.

Design: This was a prospective, multicentre, randomised controlled trial involving patients with acute NVUGIB from high-risk lesions who achieved initial endoscopic haemostasis. Participants were randomised 1:1 to receive either the haemostatic powder or no further therapy (control group). The primary outcome was the rebleeding rate within 72 hours post-treatment. Secondary outcomes included the 30-day rebleeding rate and the safety profile.

Results: A total of 341 patients (72.1% male; mean age 64.8 years) were included, with 173 in the powder group and 168 in the control group. Baseline characteristics were similar between groups. Ulcer bleeding was the predominant aetiology (n=317), with Forrest type I bleeding observed in two-thirds of cases. The 72-hour rebleeding rate was significantly lower in the powder group (2.9%, 95% CI 0.9 to 6.6%) compared with the control group (11.3%, 95% CI 6.9 to 17.1%; p =0.005). A significant reduction was also observed in the 30-day cumulative rebleeding rate (7.0% vs 18.8%), with similar findings in the ulcer subgroup for the 3-day rebleeding rate (3.0% vs 12.0%; p =0.004). No adverse events related to the powder application were reported.

Conclusion: The application of Nexpowder following endoscopic haemostasis significantly reduced both early (3 days) and late (30 days) rebleeding rates in patients with NVUGIB, particularly in cases of ulcer-related bleeding.

Trial registration number: NCT04124588.

Keywords: BLEEDING PEPTIC ULCER; ENDOSCOPIC PROCEDURES; GASTROINTESTINAL BLEEDING.