Clin Endosc.  2021 Jan;54(1):64-72. 10.5946/ce.2020.014.

Efficacy of the Envelope Method in Applying Polyglycolic Acid Sheets to Post-Endoscopic Submucosal Dissection Ulcers in Living Pigs

Affiliations
  • 1Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
  • 2KM Biologics Co., Ltd., Kumamoto, Japan

Abstract

Background/Aims
Application of polyglycolic acid (PGA) sheets using fibrin glue in post-endoscopic submucosal dissection (ESD) ulcers to prevent bleeding has been reported to be difficult with the conventional delivery method because of gravity. This study assessed the usefulness of the envelope-based delivery system with and against gravity in living pigs.
Methods
PGA sheets were applied on post-ESD ulcers with and against gravity six times each using the conventional and envelope methods, respectively. The PGA sheet delivery time and the endoscopic and histological findings of the treated ulcer floors were compared.
Results
With gravity, the median PGA sheet application time was 1.00 (0.68–1.30) min/cm2 and 0.32 (0.18–0.52) min/cm2 with the conventional and envelope techniques (p=0.002), respectively, and against gravity, it was 1.20 (1.13–1.63) min/cm2 and 0.50 (0.39–0.58) min/cm2 (p=0.002), respectively. Against gravity, the endoscopic and histological findings revealed that the conventional group had insufficient fixation of the PGA sheets, but the envelope groups had sufficient fixation. The results with gravity were similar between the groups.
Conclusions
The envelope method makes it possible to deliver PGA sheets to the stomach quickly and cover ulcers appropriately both with and against gravity in living pigs.

Keyword

Endoscopic submucosal dissection; Fibrin tissue adhesive; Gastrointestinal hemorrhage; Polyglycolic acid; Stomach

Figure

  • Fig. 1. (A) Bolheal® GI envelope (Nipro Co., Osaka, Japan). The radio-opaque string attached to the envelope (white arrow) was held using forceps during the insertion of the envelope. (B) Polyglycolic acid sheets. Three types of sheets, large, medium, and small, were used.

  • Fig. 2. (A) The method used to apply the polyglycolic acid (PGA) sheets to the ulcers. (B) The method used to fix the PGA sheets to the ulcers using fibrin glue.

  • Fig. 3. (A) Dot charts depicting the polyglycolic acid (PGA) sheet application time per square centimeter for gravitational ulcers in the conventional and envelope groups. (B) Dot charts depicting the PGA sheet application time per square centimeter for anti-gravitational ulcers in the conventional and envelope groups.

  • Fig. 4. (A) Endoscopic findings in anti-gravitational ulcers that were covered with polyglycolic acid (PGA) sheets using the conventional method. (B) Endoscopic findings in anti-gravitational ulcers that were covered with PGA sheets using the envelope method.

  • Fig. 5. (A) Hematoxylin and eosin staining (×20) of a histopathological specimen in which gaps were seen between the polyglycolic acid (PGA) sheets (yellow oval dotted line) that were fixed to an anti-gravitational ulcer site using the conventional method. (B) Hematoxylin and eosin staining (×20) of a histopathological specimen in which there were no gaps between the PGA sheets that were fixed to an anti-gravitational ulcer site using the envelope method.


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