Bipolar haemostatic forceps versus standard therapy by haemoclip+/ – epinephrine injection as initial endoscopic treatment in active non-variceal upper GI bleeding: preliminary results of a prospective, randomized multicentre trial (BeBop-Trial)

Aims Patients with active non-variceal upper gastrointestinal bleeding (NVUGIB) usually require urgent endoscopic treatment. Standard therapy (ST) with a hemoclip+/ epinephrine injection is not always successful. The bipolar haemostatic forceps (HemoStat/Pentax) is an approved medical device for the treatment of gastrointestinal bleeding. However, its use as a primary endoscopic treatment for active NVUGIB has not been proven in a randomised prospective trial. Therefore, this study aims to demonstrate that the use of bipolar haemostatic forceps in NVUGIB is superior to primary haemostasis achieved by standard therapy with epinephrine injection and clip application [1] [2].

Methods This is a prospective, randomised, multicentre (n=5) study in which patients with active NVUGIB (Forrest 1a+b) will be randomised (1:1) to ST or experimental therapy (ET). A combined endpoint of primary successful hemostasis and absence of recurrent bleeding within 30 days will be used. If the initial treatment fails within 15 minutes, a crossover treatment will be attempted first. Rescue treatment (e.g. over-the-scope clip) will then be allowed after a further 15 minutes. All patients will also receive standard proton pump inhibitor therapy. Forty-five patients per treatment arm are required to detect an absolute difference of 25.4% with 80% power and a significance level of 0.05. Trial registration number: NCT05353062.

Results In this ongoing study, 31 of 90 patients (17males) with active NVUGIB have been recruited, including 5 dropouts. 13 underwent ST and 13 underwent ET. The median age was 79 years. Overall patient characteristics were comparable. The aetiology of bleeding included patients with peptic ulcer (n=1), duodenal ulcer (n=9), erosive gastritis or duodenitis (n=3), refluxesophagitis (n=1), angiodysplasia (n=3), bleeding after endoscopic intervention (n=4), various other reasons (n=5). Primary haemostasis was achieved in 84,6% (n=11) of patients receiving ST and 76,9% (n=10) of patients receiving ET (p=1). 2 patients of the remaining 5 with failed primary haemostasis received successful crossover treatment with bipolar haemostatic forceps (n=1) or epinephrine injection and clip application (n=1). The remaining three cases received successful rescue treatment with coiling or OTS-Clip application. There were no adverse events proven or probable to be related to the procedure in either the ST or ET groups. Rebleeding within 30 days was observed in 3 patients with ST and 1 patient with ET (p=0,586).

Conclusions The preliminary results did not yet show a significant superiority of the bipolar haemostatic forceps in primary haemostasis in NVUGIB compared to the current standard of care of haemoclip+/ – epinephrine injection. Both therapies have been shown to be sufficiently safe. However, final results of the trial are not expected until after enrolment is completed in 2025.

Conflicts of Interest

Authors do not have any conflict of interest to disclose.

• References

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Publication History

Article published online:
27 March 2025