PuraStat®is a novel self-assembling peptide(SAP)used as a haemostatic agent in endoscopy,with widespread application in surgical settings.While the current evidence,though deserving further expansion,demonstrates...PuraStat®is a novel self-assembling peptide(SAP)used as a haemostatic agent in endoscopy,with widespread application in surgical settings.While the current evidence,though deserving further expansion,demonstrates a good haemostatic performance profile for this substance,there remains significant heterogeneity among studies,and an analysis of this SAP as monotherapy is not always available.The recent study by Bellester et al in the World Journal of Gastrointestinal Endoscopy provided an optimal effectiveness profile of this SAP in 45 patients treated for gastrointestinal(GI)bleeding,particularly highlighting data on its use as monotherapy in upper GI bleeding.This invited article outlines the current evidence on PuraStat®and offers a commentary on the recently published study.展开更多
BACKGROUND Hemostatic powders have been used as primary or salvage therapy to control gastrointestinal bleeding in a number of scenarios.PuraStat®is a novel,selfassembling peptide gel that has properties that dif...BACKGROUND Hemostatic powders have been used as primary or salvage therapy to control gastrointestinal bleeding in a number of scenarios.PuraStat®is a novel,selfassembling peptide gel that has properties that differ from hemostatic powders.It is transparent,can be used in narrow spaces and combined with other modalities.Also,it is pre-filled in a syringe ready to use and easy to handle and deliver.PuraStat®has been shown to be effective and safe in treating gastrointestinal bleeding lesions.But,its role as a hemostatic agent in all bleeding indications remains to be clarified.AIM To evaluate PuraStat®efficacy and its applications,feasibility and safety in treating gastrointestinal bleeding lesions.METHODS We performed a retrospective single-centre analysis of all consecutive patients with gastrointestinal bleeding,that required endoscopic treatment and where PuraStat®was applied,from June 2020 to October 2022.Demographics,biochemical,endoscopic,endoscopist assessment and outcome data were collected.We analysed the whole cohort and the subgroup with upper gastrointestinal bleeding.The primary outcome was to evaluate the efficacy of PuraStat®at achieving initial hemostasis.The patients were followed-up for 30 days after the episode of bleeding.RESULTS In total 45 patients were included,and 17/45(37.8%)females.The mean age was 65.8 years.Charlson score was>2 in 27/45(60%)and 26/45(57.8%)required transfusion.The procedures were gastroscopy(77.8%),colonoscopy(15.5%),endoscopic retrograde cholangiopancreatography(4.4%)and enteroscopy(2.2%).The most common bleeding lesion was peptic ulcer(33.3%).PuraStat®was used alone in 36%of the cases.One hundred percent achieved initial hemostasis and no complications were documented.There were no significant differences between the use of PuraStat®alone or in combination in terms of re-bleeding(P=0.64)or mortality(P=0.69).In 46.6%of cases,the reason for applying PuraStat®was as addition to standard of care,in 35.5%as an alternative because standard of care was not possible and in 17.8%as a rescue therapy.CONCLUSION PuraStat®is an effective therapy for multiple etiologies and is considered very easy to use in the majority.Its role as front line agent should be considered in the future.展开更多
BACKGROUND Endoscopic mucosal dissection has become the standard treatment for early gastric cancer.However,post-endoscopic submucosal dissection(ESD)ulcer occurs in 4.4%of patients.This study hypothesized whether app...BACKGROUND Endoscopic mucosal dissection has become the standard treatment for early gastric cancer.However,post-endoscopic submucosal dissection(ESD)ulcer occurs in 4.4%of patients.This study hypothesized whether applying PuraStat,a novel hemostatic peptide solution,prevents post-ESD bleeding.AIM To investigate the preventive potential of PuraStat,a hemostatic formulation,against bleeding in post-ESD gastric ulcers.METHODS Between May 2022 and March 2023,101 patients(Group P)underwent ESD for gastric diseases at our hospital and received PuraStat(2 mL)for post-ESD ulcers.We retrospectively compared this group with a control group(Group C)com-prising 297 patients who underwent ESD for gastric diseases at our hospital between April 2017 and March 2021.P values<0.05 on two-sided tests indicated significance.RESULTS Post-ESD bleeding occurred in 6(5.9%)(95%CI:2.8-12.4)and 20(6.7%)(95%CI:4.4-10.2)patients in Groups P and C,respectively,with no significant between-group difference.The relative risk was 1.01(95%CI:0.95-1.07).The lesser curvature or anterior wall was the bleeding site in all 6 patients who experienced postoperative bleeding in Group P.In multivariate analysis,the odds ratios for resection diameter≥50 mm and oral anticoagulant use were 6.63(95%CI:2.52-14.47;P=0.0001)and 4.04(1.26-0.69;P=0.0164),respectively.The adjusted odds ratio of post-ESD bleeding and PuraStat was 1.28(95%CI:0.28-2.15).CONCLUSION PuraStat application is not associated with post-ESD bleeding.However,the study suggests that gravitational forces may affect the effectiveness of applied PuraStat.展开更多
文摘PuraStat®is a novel self-assembling peptide(SAP)used as a haemostatic agent in endoscopy,with widespread application in surgical settings.While the current evidence,though deserving further expansion,demonstrates a good haemostatic performance profile for this substance,there remains significant heterogeneity among studies,and an analysis of this SAP as monotherapy is not always available.The recent study by Bellester et al in the World Journal of Gastrointestinal Endoscopy provided an optimal effectiveness profile of this SAP in 45 patients treated for gastrointestinal(GI)bleeding,particularly highlighting data on its use as monotherapy in upper GI bleeding.This invited article outlines the current evidence on PuraStat®and offers a commentary on the recently published study.
文摘BACKGROUND Hemostatic powders have been used as primary or salvage therapy to control gastrointestinal bleeding in a number of scenarios.PuraStat®is a novel,selfassembling peptide gel that has properties that differ from hemostatic powders.It is transparent,can be used in narrow spaces and combined with other modalities.Also,it is pre-filled in a syringe ready to use and easy to handle and deliver.PuraStat®has been shown to be effective and safe in treating gastrointestinal bleeding lesions.But,its role as a hemostatic agent in all bleeding indications remains to be clarified.AIM To evaluate PuraStat®efficacy and its applications,feasibility and safety in treating gastrointestinal bleeding lesions.METHODS We performed a retrospective single-centre analysis of all consecutive patients with gastrointestinal bleeding,that required endoscopic treatment and where PuraStat®was applied,from June 2020 to October 2022.Demographics,biochemical,endoscopic,endoscopist assessment and outcome data were collected.We analysed the whole cohort and the subgroup with upper gastrointestinal bleeding.The primary outcome was to evaluate the efficacy of PuraStat®at achieving initial hemostasis.The patients were followed-up for 30 days after the episode of bleeding.RESULTS In total 45 patients were included,and 17/45(37.8%)females.The mean age was 65.8 years.Charlson score was>2 in 27/45(60%)and 26/45(57.8%)required transfusion.The procedures were gastroscopy(77.8%),colonoscopy(15.5%),endoscopic retrograde cholangiopancreatography(4.4%)and enteroscopy(2.2%).The most common bleeding lesion was peptic ulcer(33.3%).PuraStat®was used alone in 36%of the cases.One hundred percent achieved initial hemostasis and no complications were documented.There were no significant differences between the use of PuraStat®alone or in combination in terms of re-bleeding(P=0.64)or mortality(P=0.69).In 46.6%of cases,the reason for applying PuraStat®was as addition to standard of care,in 35.5%as an alternative because standard of care was not possible and in 17.8%as a rescue therapy.CONCLUSION PuraStat®is an effective therapy for multiple etiologies and is considered very easy to use in the majority.Its role as front line agent should be considered in the future.
基金This study was reviewed and approved by the Showa University Institutional Review Board(2023-052-A).
文摘BACKGROUND Endoscopic mucosal dissection has become the standard treatment for early gastric cancer.However,post-endoscopic submucosal dissection(ESD)ulcer occurs in 4.4%of patients.This study hypothesized whether applying PuraStat,a novel hemostatic peptide solution,prevents post-ESD bleeding.AIM To investigate the preventive potential of PuraStat,a hemostatic formulation,against bleeding in post-ESD gastric ulcers.METHODS Between May 2022 and March 2023,101 patients(Group P)underwent ESD for gastric diseases at our hospital and received PuraStat(2 mL)for post-ESD ulcers.We retrospectively compared this group with a control group(Group C)com-prising 297 patients who underwent ESD for gastric diseases at our hospital between April 2017 and March 2021.P values<0.05 on two-sided tests indicated significance.RESULTS Post-ESD bleeding occurred in 6(5.9%)(95%CI:2.8-12.4)and 20(6.7%)(95%CI:4.4-10.2)patients in Groups P and C,respectively,with no significant between-group difference.The relative risk was 1.01(95%CI:0.95-1.07).The lesser curvature or anterior wall was the bleeding site in all 6 patients who experienced postoperative bleeding in Group P.In multivariate analysis,the odds ratios for resection diameter≥50 mm and oral anticoagulant use were 6.63(95%CI:2.52-14.47;P=0.0001)and 4.04(1.26-0.69;P=0.0164),respectively.The adjusted odds ratio of post-ESD bleeding and PuraStat was 1.28(95%CI:0.28-2.15).CONCLUSION PuraStat application is not associated with post-ESD bleeding.However,the study suggests that gravitational forces may affect the effectiveness of applied PuraStat.