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Background <p>Endoscopic retrograde cholangiopancreatography (ERCP) remains a cornerstone therapeutic intervention for pancreatobiliary disease but is associated with serious adverse events. Bleeding related to endoscopic sphincterotomy or periampullary manipulation may be difficult to control because of anatomic constraints and patient-related risk factors. PuraStat™ is a transparent self-assembling peptide (SAP) hydrogel that promotes hemostasis and healing. Data specific to the efficacy of SAP in ERCP-related bleeding remains limited.</p> Methods <p>We performed a multicenter, prospective, observational study including consecutive ERCP procedures between January 2022 and December 2025 in which SAP was used to treat ERCP-related bleeding (intraprocedural bleeding (IPB) or delayed bleeding) and prophylactic application for prevention of delayed bleeding after sphincterotomy in high-risk patients. The primary outcome was immediate hemostasis, and secondary outcomes included technical success, 30-day rebleeding, and adverse events related to use of SAP.</p> Results <p>A total of 138 patients were included. The mean age was 51.3 years (SD 16.8), with 91 (65.9%) females and 20.3% on antithrombotic therapy. The main indication for ERCP was choledocholithiasis (77.5%), followed by pancreaticobiliary malignancy (18.1%). SAP was predominantly used to treat IPB (82.6%) but was also used for treating delayed bleeding (10.9%) and prophylactically (6.5%). The severity of bleeding was mild in 68.2%, while the remainder had moderate bleeding. Technical success was achieved in all patients. SAP achieved immediate hemostasis in 97.7% of patients with active bleeding. 30-day rebleeding occurred in 7 patients (5.1%), while other adverse events occurred in 5 patients (3.6%), all of whom had post-ERCP pancreatitis, with no reported procedure-related mortality. Subgroup analysis revealed equal efficacy when SAP was used as a primary or secondary (rescue) therapy but significantly improved outcomes when used for mild (oozing) bleeding compared to moderately severe bleeding.</p> Conclusions <p>In this real-world cohort, SAP appeared to be a technically feasible and safe hemostatic agent for ERCP-related bleeding, with favorable hemostatic outcomes.</p> Graphical abstract <p></p>

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Use of the self-assembling peptide (PuraStat™) for the management and prevention of ERCP-related bleeding: a multicenter prospective cohort study

  • 期刊论文

  • 发表日期：

    2026年7月27日

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  • Ali A. Alali,
  • Asma A. Alkandari,
  • Ahmad Hashim,
  • Raed Alzafiri,
  • Pradeep Bhandari

摘要

Background

Endoscopic retrograde cholangiopancreatography (ERCP) remains a cornerstone therapeutic intervention for pancreatobiliary disease but is associated with serious adverse events. Bleeding related to endoscopic sphincterotomy or periampullary manipulation may be difficult to control because of anatomic constraints and patient-related risk factors. PuraStat™ is a transparent self-assembling peptide (SAP) hydrogel that promotes hemostasis and healing. Data specific to the efficacy of SAP in ERCP-related bleeding remains limited.

Methods

We performed a multicenter, prospective, observational study including consecutive ERCP procedures between January 2022 and December 2025 in which SAP was used to treat ERCP-related bleeding (intraprocedural bleeding (IPB) or delayed bleeding) and prophylactic application for prevention of delayed bleeding after sphincterotomy in high-risk patients. The primary outcome was immediate hemostasis, and secondary outcomes included technical success, 30-day rebleeding, and adverse events related to use of SAP.

Results

A total of 138 patients were included. The mean age was 51.3 years (SD 16.8), with 91 (65.9%) females and 20.3% on antithrombotic therapy. The main indication for ERCP was choledocholithiasis (77.5%), followed by pancreaticobiliary malignancy (18.1%). SAP was predominantly used to treat IPB (82.6%) but was also used for treating delayed bleeding (10.9%) and prophylactically (6.5%). The severity of bleeding was mild in 68.2%, while the remainder had moderate bleeding. Technical success was achieved in all patients. SAP achieved immediate hemostasis in 97.7% of patients with active bleeding. 30-day rebleeding occurred in 7 patients (5.1%), while other adverse events occurred in 5 patients (3.6%), all of whom had post-ERCP pancreatitis, with no reported procedure-related mortality. Subgroup analysis revealed equal efficacy when SAP was used as a primary or secondary (rescue) therapy but significantly improved outcomes when used for mild (oozing) bleeding compared to moderately severe bleeding.

Conclusions

In this real-world cohort, SAP appeared to be a technically feasible and safe hemostatic agent for ERCP-related bleeding, with favorable hemostatic outcomes.

Graphical abstract