title: A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach.
abstract: OBJECTIVE
  Endoscopic submucosal dissection (ESD) can remove early stage GI tumors of various sizes en bloc; however, success requires reducing the relatively high postprocedure bleeding rate. The aim of this study was to assess the safety and efficacy of a novel, fully synthetic, and self-assembled peptide solution that functions as an extracellular matrix scaffold material to facilitate reconstruction of normal tissues in ESD-induced ulcers.
  
  
  METHODS
  Consecutive patients who underwent gastric ESD were prospectively enrolled. Immediately after the resection, the solution was applied to the site with a catheter. Gastric ulcers were evaluated by endoscopy and classified as active, healing, or scarring stages at weeks 1, 4, and 8 after ESD.
  
  
  RESULTS
  Forty-seven patients with 53 lesions, including 14 (29.8%) previously on antithrombotic therapy and 2 (4.3%) requiring heparin bridge therapy, were analyzed; 2 patients were excluded, 1 with perforations and 1 with persistent coagulopathy. The mean size of the en bloc resected specimens was 36.5 ± 11.3 mm. The rate of post-ESD bleeding was 2.0% (1/51; 95% CI, 0.03-10.3). Transitional rate to the healing stage of ESD-induced ulcers at week 1 was 96% (49/51). Subsequent endoscopies demonstrated the scarring stage in 19% (9/48) and 98% (41/42) at weeks 4 and 8, respectively. No adverse effects related to this solution occurred.
  
  
  CONCLUSIONS
  The use of this novel peptide solution may potentially aid in reducing the delayed bleeding rate by promoting mucosal regeneration and speed of ulcer healing after large endoscopic resections in the stomach. Further studies, particularly randomized controlled studies, are needed to fully evaluate its efficacy. (
  
  
  BACKGROUND
  000011548.).
authors.affiliation: Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan; Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Uraoka
authors.affiliation: Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Yasutoshi
authors.initials: Y
authors.lastname: Ochiai
authors.affiliation: Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Ai
authors.initials: A
authors.lastname: Fujimoto
authors.affiliation: Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Goto
authors.affiliation: Department of Endoscopy, Okayama University Hospital, Okayama, Japan.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Kawahara
authors.affiliation: Okayama Saidaiji Hospital, Okayama, Japan.
authors.forename: Naoya
authors.initials: N
authors.lastname: Kobayashi
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Kanai
authors.affiliation: Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Sachiko
authors.initials: S
authors.lastname: Matsuda
authors.affiliation: Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
authors.affiliation: Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Naohisa
authors.initials: N
authors.lastname: Yahagi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D000069916:Endoscopic Mucosal Resection / Q000009:adverse effects*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology; D005773:Gastroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000453:epidemiology; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000209:etiology; D047368:Tumor Burden
chemical_list: D000925:Anticoagulants; D010455:Peptides; C546681:RADA16-I