P4333 - Comparison of a Novel Self-Assembling Peptide Gel and Conventional Techniques for Endoscopic Hemostasis in Post Sphincterotomy Bleeding: A Systematic Review and Meta-Analysis

Award: ACG Presidential Poster Award

Aamir Saeed, MD¹, Ghulam Ali Hasnan, MBBS², Marjan Haider, MD³, Absar Mukhtar, MBBS⁴, Hooria Ejaz, MBBS⁴, Saira Yousuf, MD¹, Muhammad Hassan, MBBS⁵, Umar Hayat, MD⁶, Muhammad Waqar Elahi, MD⁷, Hafsah Ijaz, MD⁸, Nilay Bhatt, MD⁹, Amman Yousaf, MD¹⁰, Muhammad Abdul Basit, MD¹¹, Sam Dabit, ¹², Faisal Kamal, MD¹³
1Vanderbilt University Medical Center, Nashville, TN; 2Dr Grays Hospital NHS Grampian, Elgin, Scotland, United Kingdom; 3Trinity Health Ann Arbor Hospital, Ypsilanti, MI; 4Services Hospital Lahore, Lahore, Punjab, Pakistan; 5Sharif medical and dental college, Lahore, Punjab, Pakistan; 6Geisinger Wyoming Valley Medical Center, Wilkes-Barre, PA; 7West Virginia University School of Medicine, Morgantown, WV; 8Capital Health New Jersey, Trenton, NJ; 9HCA Houston Clear Lake, Houston, TX; 10Hattiesburg Clinic, Hattiesburg, Hattiesburg, MS; 11United Health Services, Binghamton, NY; 12South Central Regional Medical Center, Laurel, MS; 13Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA

Introduction: Bleeding after endoscopic sphincterotomy (ES) remains a major challenge. Standard endoscopic hemostatic procedures have demonstrated good performance for bleeding control. Recently, a novel self-assembling peptide hemostatic gel (PuraStat) has been widely used in gastrointestinal bleeding. However, the safety and efficacy of this novel self-assembling peptide hemostatic gel remain unclear for bleeding after ES. We conducted a meta-analysis to compare the safety and efficacy of PuraStat and conventional techniques for endoscopic hemostasis in post sphincterotomy bleeding.

Methods: Several databases were reviewed from inception to Januray18, 2025, to identify studies comparing the outcomes of PuraStat and conventional techniques for post ES bleeding. Our outcomes of interest were initial hemostasis, rebleeding, and adverse events. We calculated risk ratios (RRs) with 95% CI for categorical variables and mean differences with 95% CI for continuous variables. Data was analyzed using the random effect model. Heterogeneity was assessed using I 2 statistics.

Results: We included 7 studies with 879 patients (PuraStat 379, control 500) in our analysis. The mean age of the patients was 69.7 (9) years. Pooled rates of (95 CI%) of initial hemostasis with PuraStat were 94.6% (88.2%, 97.6%), p=0.4, I2=1%, rebleeding, 4.5% (0.9%, 19.1%), p=0, I2=80%, and adverse events 6% (2%, 16.7%), p=0.001, I2=75%. PuraStat was associated with higher rates of initial hemostasis, RR (95 CI%), 1.02(0.89, 1.18), P=0.75, I2=53% (Figure 1), and lower adverse events, RR (95 CI%), 0.68(0.15, 3.13), P=0.62, I2=75%, however, results were not statistically significant.

Comparative analysis of PuraStat and conventional therapies showed that PuraStat was associated with lower rates of rebleeding, RR (95 CI%), 0.35(0.13, 0.97), P=0.04, I2=0% (Figure 2).

Discussion: Our meta-analysis demonstrates safety and efficacy of PuraStat in endoscopic hemostasis in post ES bleeding, PuraStat was associated with lower rates of rebleeding as compared to conventional therapies. Future multicenter studies are needed to validate these findings further.


Figure: Figure 1: Comparison of initial hemostasis between the groups


Figure: Figure 2: Comparison of rebleeding between the groups

Disclosures:
Aamir Saeed indicated no relevant financial relationships.
Ghulam Ali Hasnan indicated no relevant financial relationships.
Marjan Haider indicated no relevant financial relationships.
Absar Mukhtar indicated no relevant financial relationships.
Hooria Ejaz indicated no relevant financial relationships.
Saira Yousuf indicated no relevant financial relationships.
Muhammad Hassan indicated no relevant financial relationships.
Umar Hayat indicated no relevant financial relationships.
Muhammad Waqar Elahi indicated no relevant financial relationships.
Hafsah Ijaz indicated no relevant financial relationships.
Nilay Bhatt indicated no relevant financial relationships.
Amman Yousaf indicated no relevant financial relationships.
Muhammad Abdul Basit indicated no relevant financial relationships.
Sam Dabit indicated no relevant financial relationships.
Faisal Kamal indicated no relevant financial relationships.

Aamir Saeed, MD¹, Ghulam Ali Hasnan, MBBS², Marjan Haider, MD³, Absar Mukhtar, MBBS⁴, Hooria Ejaz, MBBS⁴, Saira Yousuf, MD¹, Muhammad Hassan, MBBS⁵, Umar Hayat, MD⁶, Muhammad Waqar Elahi, MD⁷, Hafsah Ijaz, MD⁸, Nilay Bhatt, MD⁹, Amman Yousaf, MD¹⁰, Muhammad Abdul Basit, MD¹¹, Sam Dabit, ¹², Faisal Kamal, MD¹³. P4333 - Comparison of a Novel Self-Assembling Peptide Gel and Conventional Techniques for Endoscopic Hemostasis in Post Sphincterotomy Bleeding: A Systematic Review and Meta-Analysis, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.