DOI QR코드

DOI QR Code

Systematic review of self-assembling peptides as topical agents for treatment and prevention of gastrointestinal bleeding

  • Andrei Voiosu (Gastroenterology Department, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy) ;
  • Monica State (Gastroenterology Department, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy) ;
  • Victor Dragan (Gastroenterology Department, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy) ;
  • Sergiu Vaduva (Gastroenterology Department, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy) ;
  • Paul Balanescu (Gastroenterology Department, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy) ;
  • Radu Bogdan Mateescu (Gastroenterology Department, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy) ;
  • Theodor Voiosu (Gastroenterology Department, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy)
  • Received : 2023.07.04
  • Accepted : 2023.09.30
  • Published : 2024.07.30

Abstract

Background/Aims: Gastrointestinal bleeding is a significant and potentially lethal event. We aimed to review the efficiency and safety of self-assembling peptides for the treatment and prevention of gastrointestinal tract bleeding. Methods: We conducted a systematic search for studies describing the endoscopic use of self-assembling peptides for treatment or prevention of bleeding in the gastrointestinal tract in a parallel, independent fashion. The primary outcomes were rates of successful initial hemostasis, delayed bleeding, and rebleeding. The secondary outcomes were adverse events and ease and volume of gel used. Results: Seventeen studies were analyzed. Overall success rate of self-assembling peptides in gastrointestinal bleeding was 87.7% (38%-100%), regardless of etiology or associated treatments. Rebleeding rate ranged from 0% to 16.2%, with a mean of 4.7%, and overall delayed bleeding rate was 5% (range, 0%-15.9%). Only three adverse events were reported in a pooled number of 815 patients. The volume of gel used varied (0.43 to 3.7 mL) according to indication and type of bleeding. Conclusions: The limited available data on the use of self-assembling peptides in gastrointestinal endoscopy suggest a high efficiency and good safety profile.

Keywords

References

  1. Laursen SB, Stanley AJ, Laine L, et al. Rebleeding in peptic ulcer bleeding: a nationwide cohort study of 19,537 patients. Scand J Gastroenterol 2022;57:1423-1429.
  2. Gralnek IM, Stanley AJ, Morris AJ, et al. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline: Update 2021. Endoscopy 2021;53:300-332.
  3. ASGE Technology Committee, Parsi MA, Schulman AR, et al. Devices for endoscopic hemostasis of nonvariceal GI bleeding (with videos). VideoGIE 2019;4:285-299.
  4. Voiosu A. Commentary. Endoscopy 2022;54:1234-1235.
  5. Nishiyama N, Kobara H, Kobayashi N, et al. Efficacy of endoscopic ligation with O-ring closure for prevention of bleeding after gastric endoscopic submucosal dissection under antithrombotic therapy: a prospective observational study. Endoscopy 2022;54:1078-1084.
  6. Gangwani MK, Ahuja P, Aziz A, et al. Role of prophylactic hemoclip placement in prevention of delayed post-polypectomy bleeding for large colon polyps: a meta-analysis of randomized controlled trials. Ann Gastroenterol 2021;34:392-398.
  7. Zhang S, Holmes T, Lockshin C, et al. Spontaneous assembly of a self-complementary oligopeptide to form a stable macroscopic membrane. Proc Natl Acad Sci U S A 1993;90:3334-3338.
  8. Ellis-Behnke RG, Liang YX, Tay DK, et al. Nano hemostat solution: immediate hemostasis at the nanoscale. Nanomedicine 2006;2:207-215.
  9. Masuhara H, Fujii T, Watanabe Y, et al. Novel infectious agent-free hemostatic material (TDM-621) in cardiovascular surgery. Ann Thorac Cardiovasc Surg 2012;18:444-451.
  10. Friedland Y, Bagot d'Arc MB, Ha J, et al. The use of self-assembling peptides (PuraStatTM) in functional endoscopic sinus surgery for haemostasis and reducing adhesion formation: a case series of 94 patients. Surg Technol Int 2022;41:sti41/1594.
  11. Gangner Y, Bagot d'Arc M, Delin C. The use of self-assembling peptides (PuraStat) for hemostasis in cervical endocrine surgery: a real-life case series of 353 patients. Int J Surg Case Rep 2022;94:107072.
  12. Nahm CB, Popescu I, Botea F, et al. A multi-center post-market clinical study to confirm safety and performance of PuraStat® in the management of bleeding during open liver resection. HPB (Oxford) 2022;24:700-707.
  13. U.S. Food and Drug Administration. K210098 [Internet]. U.S. Food and Drug Administration; 2021 [cited 2022 Nov 15]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210098.pdf
  14. Slim K, Nini E, Forestier D, et al. Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg 2003;73:712-716.
  15. Clark HD, Wells GA, Huet C, et al. Assessing the quality of randomized trials: reliability of the Jadad scale. Control Clin Trials 1999;20:448-452.
  16. Arndtz S, Subramaniam S, Hossain E, et al. Outcomes from the UK purastat® registry: multicentre observational study of purastat® use in gastrointestinal bleeding. Gut 2021;70:A45-A46.
  17. Branchi F, Klingenberg-Noftz R, Friedrich K, et al. PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study. Surg Endosc 2022;36:2954-2961.
  18. Subramaniam S, Kandiah K, Thayalasekaran S, et al. Haemostasis and prevention of bleeding related to ER: the role of a novel self-assembling peptide. United European Gastroenterol J 2019;7:155-162.
  19. Uedo N, Uraoka T, Saito Y, et al. A new hemostatic peptide solution for reduction of electrocauterization during endoscopic submucosal dissection: a multicenter randomized controlled trial. Gastrointest Endosc 2022;95(6 Supplement):AB465.
  20. de Nucci G, Reati R, Arena I, et al. Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding. Endoscopy 2020;52:773-779.
  21. Pioche M, Camus M, Rivory J, et al. A self-assembling matrix-forming gel can be easily and safely applied to prevent delayed bleeding after endoscopic resections. Endosc Int Open 2016;4:E415-E419.
  22. Subramaniam S, Kandiah K, Chedgy F, et al. A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy 2021;53:27-35.
  23. Uraoka T, Ochiai Y, Fujimoto A, et al. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointest Endosc 2016;83:1259-1264.
  24. Soons E, Turan A, van Geenen E, et al. Application of a novel self-assembling peptide to prevent hemorrhage after EMR, a feasibility and safety study. Surg Endosc 2021;35:3564-3571.
  25. Choi JH, Cho IR, Lee SH, et al. Efficacy and safety of novel hemostatic gel in endoscopic sphincterotomy or endoscopic papillectomy: a multicenter, single-blinded, prospective, randomized controlled clinical trial. Gastrointest Endosc 2022;95:AB341-AB342.
  26. Labianca O, Sica M, Zulli C, et al. Use of Purastat in management of gastro-intestinal bleeding: our experience. Endoscopy 2021;53:S97-S98.
  27. White K, Henson CC. Endoscopically delivered Purastat for the treatment of severe haemorrhagic radiation proctopathy: a service evaluation of a new endoscopic treatment for a challenging condition. Frontline Gastroenterol 2021;12:608-613.
  28. Woolley M, Subhaharan D, Bassan M, et al. Efficacy of a novel peptide haemostatic gel in prevention of bleeding post endoscopic resection of large duodenal adenomas. Endoscopy 2022;54(S 01):S282.
  29. Yoshida M, Goto N, Kawaguchi M, et al. Initial clinical trial of a novel hemostat, TDM-621, in the endoscopic treatments of the gastric tumors. J Gastroenterol Hepatol 2014;29 Suppl 4:77-79.
  30. Soriani P, Mirante VG, Barbera C, et al. Novel endoscopic tool to prevent delayed bleeding after wide endoscopic resections in high risk patients: an initial single-centre experience. Dig Liver Dis 2018;50:e146.
  31. Stammers M, Boger P, Patel P, et al. Comparison between 4% formalin instillation and purastat application for radiation proctopathy. Gut 2021;70(Suppl 1):A79.
  32. Ishida Y, Tsuchiya N, Koga T, et al. A novel self-assembling peptide hemostatic gel as an option for initial hemostasis in endoscopic sphincterotomy-related hemorrhage: a case series. Clin J Gastroenterol 2022;15:1210-1215.
  33. Chung IK, Ham JS, Kim HS, et al. Comparison of the hemostatic efficacy of the endoscopic hemoclip method with hypertonic saline-epinephrine injection and a combination of the two for the management of bleeding peptic ulcers. Gastrointest Endosc 1999;49:13-18.
  34. Chung IK, Kim EJ, Lee MS, et al. Bleeding Dieulafoy's lesions and the choice of endoscopic method: comparing the hemostatic efficacy of mechanical and injection methods. Gastrointest Endosc 2000;52:721-724.
  35. Hamada S, Teramoto A, Zukeyama R, et al. Efficacy of combination therapy with epinephrine local injection and hemostatic clips on active diverticular bleeding. J Clin Med 2022;11:5195.
  36. Sung JJ, Tsoi KK, Lai LH, et al. Endoscopic clipping versus injection and thermo-coagulation in the treatment of non-variceal upper gastrointestinal bleeding: a meta-analysis. Gut 2007;56:1364-1373.
  37. Kataoka M, Kawai T, Hayama Y, et al. Comparison of hemostasis using bipolar hemostatic forceps with hemostasis by endoscopic hemoclipping for nonvariceal upper gastrointestinal bleeding in a prospective non-randomized trial. Surg Endosc 2013;27:3035-3038.
  38. Yuan Y, Wang C, Hunt RH. Endoscopic clipping for acute nonvariceal upper-GI bleeding: a meta-analysis and critical appraisal of randomized controlled trials. Gastrointest Endosc 2008;68:339-351.
  39. Rosenstock SJ, Moller MH, Larsson H, et al. Improving quality of care in peptic ulcer bleeding: nationwide cohort study of 13,498 consecutive patients in the Danish Clinical Register of Emergency Surgery. Am J Gastroenterol 2013;108:1449-1457.
  40. McWhinney CD, Vemulapalli KC, El Rahyel A, et al. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions ≥10 mm. Gastrointest Endosc 2021;93:654-659.
  41. Ferlitsch M, Moss A, Hassan C, et al. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2017;49:270-297.
  42. Pimentel-Nunes P, Libanio D, Bastiaansen BA, et al. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy 2022;54:591-622.
  43. Jung DH, Park JC. Strategies that reduce post-endoscopic submucosal dissection bleeding. Korean J Helicobacter Up Gastrointest Res 2021;21:194-202.
  44. 3-D Matrix Medical Technology. PuraStat: the first haemostat approved to reduce delayed bleeding following ESD in the colon [Internet]. 3-D Matrix Medical Technology; 2021 [cited 2022 Nov 15]. Available from: https://www.healthcare21.eu/product/purastat/?attachment_id=11084&download_file=t9f02uom9wa1h
  45. Cryer BL, Wilcox CM, Henk HJ, et al. The economics of upper gastrointestinal bleeding in a US managed-care setting: a retrospective, claims-based analysis. J Med Econ 2010;13:70-77.
  46. Bartell N, Bittner K, Kaul V, et al. Clinical efficacy of the over-the-scope clip device: a systematic review. World J Gastroenterol 2020;26:3495-3516.
  47. Zhong C, Tan S, Ren Y, et al. Clinical outcomes of over-the-scope-clip system for the treatment of acute upper non-variceal gastrointestinal bleeding: a systematic review and meta-analysis. BMC Gastroenterol 2019;19:225.
  48. Chandrasekar VT, Desai M, Aziz M, et al. Efficacy and safety of over-the-scope clips for gastrointestinal bleeding: a systematic review and meta-analysis. Endoscopy 2019;51:941-949.
  49. Mutneja H, Bhurwal A, Go A, et al. Efficacy of hemospray in upper gastrointestinal bleeding: a systematic review and meta-analysis. J Gastrointestin Liver Dis 2020;29:69-76.
  50. Facciorusso A, Bertini M, Bertoni M, et al. Effectiveness of hemostatic powders in lower gastrointestinal bleeding: a systematic review and meta-analysis. Endosc Int Open 2021;9:E1283-E1290.
  51. Misumi Y, Nonaka K. Prevention and management of complications and education in endoscopic submucosal dissection. J Clin Med 2021;10:2511.
  52. Bishay K, Meng ZW, Frehlich L, et al. Prophylactic clipping to prevent delayed colonic post-polypectomy bleeding: meta-analysis of randomized and observational studies. Surg Endosc 2022;36:1251-1262.
  53. Lau LH, Guo CL, Lee JK, et al. Effectiveness of prophylactic clipping in preventing postpolypectomy bleeding in oral anticoagulant users: a propensity-score analysis. Gastrointest Endosc 2022;96:530-542.
  54. Ayoub F, Westerveld DR, Forde JJ, et al. Effect of prophylactic clip placement following endoscopic mucosal resection of large colorectal lesions on delayed polypectomy bleeding: a meta-analysis. World J Gastroenterol 2019;25:2251-2263.
  55. Forbes N, Gupta S, Frehlich L, et al. Clip closure to prevent adverse events after EMR of proximal large nonpedunculated colorectal polyps: meta-analysis of individual patient data from randomized controlled trials. Gastrointest Endosc 2022;96:721-731.
  56. Yang TC, Wu YH, Lee PC, et al. Prophylactic clipping after endoscopic mucosal resection of large nonpedunculated colorectal lesions: a meta-analysis. J Gastroenterol Hepatol 2021;36:1778-1787.
  57. Nishizawa T, Suzuki H, Goto O, et al. Effect of prophylactic clipping in colorectal endoscopic resection: a meta-analysis of randomized controlled studies. United European Gastroenterol J 2017;5:859-867.
  58. Chen B, Du L, Luo L, et al. Prophylactic clips to reduce delayed polypectomy bleeding after resection of large colorectal polyps: a systematic review and meta-analysis of randomized trials. Gastrointest Endosc 2021;93:807-815.
  59. Qiu J, Xu J, Zhang Y, et al. Over-the-scope clip applications as first-line therapy in the treatment of upper non-variceal gastrointestinal bleeding, perforations, and fistulas. Front Med (Lausanne) 2022;9:753956.
  60. Nakahara K, Sekine A, Tateishi K. Self-assembling peptide gel application to achieve endoscopic hemostasis for fistula bleeding after lumen apposing metal stent removal. Dig Endosc 2023;35:e48-e49.
  61. Soriani P, Biancheri P, Deiana S, et al. Off-label PuraStat use for the treatment of acute intrahepatic biliary duct bleeding. Endosc Int Open 2021;9:E1926-E1927.
  62. Kubo K. Delayed bleeding following percutaneous endoscopic gastrostomy successfully treated with PuraStat®. Intern Med 2023;62:487-488.
  63. Karna R, Deliwala S, Ramgopal B, et al. Efficacy of topical hemostatic agents in malignancy-related GI bleeding: a systematic review and meta-analysis. Gastrointest Endosc 2023;97:202-208.