Endoscopic treatment serves as the first-line approach in managing upper gastrointestinal
bleeding (UGIB), demonstrating effectiveness in reducing re-bleeding rates, the need for
surgical intervention, and mortality. In non-variceal UGIB, endoscopic management
includes various techniques such as injection therapy, thermal therapy, mechanical
therapy, or a combination, depending on the lesion type. However, certain factors,
including the anatomical location of the lesion, underlying fibrosis, or diffuse
bleeding, can present challenges to successful treatment.
Haemostatic powders have been increasingly utilized as both primary and salvage therapy
for bleeding control in various clinical scenarios, including post-polypectomy bleeding,
bleeding associated with colonic tumors, diverticula, arteriovenous malformations,
radiation proctitis, ischemic colitis, and surgical intestinal anastomoses. Their use in
UGIB management has also expanded. Compared to other modalities, these topical agents
offer advantages such as ease of application, the ability to reach lesions in challenging
locations, and coverage of larger surface areas without requiring precise targeting.
Among the most extensively studied topical hemostatic agents are TC-325 (Hemospray®, Cook
Medical), the Polysaccharide Hemostatic System (Endoclot® PHS), and Inha
University-Endoscopic Wound Dressing (UI-EWD) (NextBiomedical Co., Incheon, South Korea).
These agents have demonstrated high rates of immediate haemostasis (86%-100%) when used
alone or in combination with other haemostatic methods, exhibiting excellent feasibility
and a favorable safety profile.
The primary limitation of these agents is their adherence exclusively to actively
bleeding sites, leading to rapid washout within 12-24 hours, thereby making them a
temporary measure. Additionally, their opacity obscures the underlying mucosa after
application, preventing further visualization of the lesion during the procedure. Further
studies are required to better define the role of hemostatic powders, establish optimal
use settings, and evaluate long-term efficacy and safety in bleeding control.
PuraStat® is a novel gel that provides several advantages over traditional hemostatic
powders. Its transparency allows for continuous visualization of the bleeding site, and
it can be applied in narrow spaces or in combination with other treatments. The
pre-filled syringe design facilitates ease of handling and precise delivery.
To date, most published data on PuraStat® as a haemostatic agent originates from surgical
settings. In endoscopy, its primary applications have been in polypectomy-related
haemostasis and the promotion of wound healing. Reports indicate a haemostasis success
rate of 90.4%, with a recurrence rate of 10.4%. However, data on its efficacy in UGIB
lesions remain limited.
This study hypothesizes that PuraStat®, when combined with Adrenaline, represents a
feasible and effective first-line treatment for gastrointestinal bleeding, potentially
matching or surpassing the current standard of care. A prospective, randomized,
parallel-group, open-label clinical trial is proposed. During endoscopy, patients
requiring treatment will be randomly assigned to one of two groups: standard care or
Adrenaline injection combined with PuraStat®. If haemostasis is not achieved with the
initial treatment, the alternative approach will be applied. Patients will be monitored
for 30 days to assess bleeding recurrence. The study aims to enroll 126 patients (63 per
group).