title: A novel endoscopic prototype device for gastric full-thickness biopsy for the histopathologic diagnosis of GI neuromuscular pathology: in vivo porcine long-term survival study (with videos).
abstract: BACKGROUND
  Many GI motility disorders are associated with underlying GI neuromuscular pathology, which requires full-thickness biopsies (FTB) for histopathologic diagnosis. Currently, none of the endoscopy-based attempts to obtain FTB specimens have proven suitable for routine use. This study evaluated a novel endoscopic prototype device (ED) for this purpose.
  
  
  OBJECTIVE
  To determine (1) the ability of the ED to obtain suitable FTB specimens, (2) associated complications, (3) feasibility of reliable defect closure, and (4) ability to evaluate intramural neuromuscular components.
  
  
  METHODS
  Preclinical proof-of-concept study in 30 pigs.
  
  
  METHODS
  Animal laboratory.
  
  
  METHODS
  Gastric FTB specimens were obtained with a circular cutter and anchor. The defect was closed by over-the-scope clips/T-tags. The resection site was inspected via laparoscopy. After 2 to 4 weeks, necropsy was carried out to evaluate late complications.
  
  
  METHODS
  Feasibility, safety, and closure rate of the procedure. FTB specimens were assessed by histology/immunohistochemistry to visualize enteric neuromusculature.
  
  
  RESULTS
  A total of 29 of 30 procedures were successfully performed; one hemorrhage required endoscopic treatment. A total of 29 of 30 FTB specimens (mean diameter 9.1 mm) were retrieved in 7.1 ± 0.4 minutes (range 3.0-12.5 minutes), displaying optimal tissue quality. Defect closure took 10.8 ± 0.9 minutes (range 7.2-32 minutes). Laparoscopy did not reveal damage to adjacent organs. Necropsy showed well-healed scars at the resection site and no complications, peritonitis, or abscess formation. Histology showed smooth muscle layers and submucosal and myenteric ganglia.
  
  
  CONCLUSIONS
  Survival animal pilot study, no patients.
  
  
  CONCLUSIONS
  The novel ED enabled safe harvesting of well-preserved FTB specimens. Defect closure proved to be reliable. All neuromuscular structures relevant for histopathologic evaluation of GI neuromuscular pathology were demonstrated. Further studies are needed to verify the efficacy of this prototype device in the entire gut and in humans.
authors.affiliation: Experimental Endoscopy, Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Germany. fri.rav@btopenworld.com
authors.forename: Annette
authors.initials: A
authors.lastname: Fritscher-Ravens
authors.forename: Peter
authors.initials: P
authors.lastname: Milla
authors.forename: Mark
authors.initials: M
authors.lastname: Ellrichmann
authors.forename: Ines
authors.initials: I
authors.lastname: Hellwig
authors.forename: Martina
authors.initials: M
authors.lastname: Böttner
authors.forename: Klaus-Gerd
authors.initials: KG
authors.lastname: Hadeler
authors.forename: Thilo
authors.initials: T
authors.lastname: Wedel
mesh_terms: D000818:Animals; D001706:Biopsy / Q000295:instrumentation* / Q000379:methods; D005240:Feasibility Studies; D005773:Gastroscopy; D009130:Muscle, Smooth / Q000473:pathology; D009468:Neuromuscular Diseases / Q000473:pathology*; D010865:Pilot Projects; D013270:Stomach / Q000294:innervation / Q000473:pathology*; D013552:Swine; D058106:Wound Closure Techniques / Q000295:instrumentation