Efficacy and safety of a novel submucosal lifting gel used for endoscopic submucosal dissection

a study in a porcine model

D. W. Schölvinck, L. Alvarez Herrero, O. Goto, S. L. Meijer, H. Neuhaus, B. Schumacher, J. J G H M Bergman, B. L A M Weusten

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background and study aims: Endoscopic submucosal dissection (ESD) is technically demanding. A viscous gel for submucosal lifting might induce mechanical submucosal dissection facilitating easier and safer ESD. Methods: In 12 female pigs (median 64 kg), ESDs of simulated lesions were performed at the posterior wall and greater curvature in the gastric body (one ESD per location) with randomly assigned injection fluids: gel or control fluid (0.9 % saline with hydroxypropyl methylcellulose 3 mg/ml [7:1] and indigo carmine droplets). Additionally, 10 cc gel was injected into the submucosa at the anterior wall without ESD to assess effects of inappropriate injection. Pigs were euthanized at day 0, 3 or 28. In four additional pigs (euthanized day 3 or 28) 10 cc gel was injected into the muscularis propria (MP) after four endoscopic mucosal resections in the gastric body. Results: Both fluid groups showed equal ESD-procedure times (28 [gel] vs. 26 min [control]) and complications. Gel-ESDs required less accessory interchanges (3.5 vs. 5.5; p = 0.01). Mechanical dissection after circumferential incision was achieved in 25 % of gel-ESDs; none in control-ESDs. The severity of inflammation and fibrosis was equal in both fluid groups. Normal architecture and vital mucosa were found after inappropriate submucosal injection. MP-injections resulted in one transmural hematoma (day 3), and intramuscular encapsulation in 25 % of the sites (day 28). Limitations: A pig’s stomach differs from the human stomach. Conclusions: The mechanical dissection properties of the gel may reduce the need for submucosal dissection during ESD. The gel is safe when advertently injected in the submucosa and MP. The porcine model appeared suboptimal to evaluate the true mechanical dissection properties of the gel.

Original languageEnglish
Pages (from-to)2651-2660
Number of pages10
JournalSurgical Endoscopy and Other Interventional Techniques
Volume29
Issue number9
DOIs
Publication statusPublished - 2015 Sep 21

Fingerprint

Swine
Gels
Safety
Dissection
Stomach
Injections
Endoscopic Mucosal Resection
Indigo Carmine
Hematoma
Mucous Membrane
Fibrosis
Inflammation

Keywords

  • Endoscopic submucosal dissection
  • Gastric neoplasia
  • Injection fluid
  • Swine

ASJC Scopus subject areas

  • Surgery

Cite this

Schölvinck, D. W., Alvarez Herrero, L., Goto, O., Meijer, S. L., Neuhaus, H., Schumacher, B., ... Weusten, B. L. A. M. (2015). Efficacy and safety of a novel submucosal lifting gel used for endoscopic submucosal dissection: a study in a porcine model. Surgical Endoscopy and Other Interventional Techniques, 29(9), 2651-2660. https://doi.org/10.1007/s00464-014-3985-9

Efficacy and safety of a novel submucosal lifting gel used for endoscopic submucosal dissection : a study in a porcine model. / Schölvinck, D. W.; Alvarez Herrero, L.; Goto, O.; Meijer, S. L.; Neuhaus, H.; Schumacher, B.; Bergman, J. J G H M; Weusten, B. L A M.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 29, No. 9, 21.09.2015, p. 2651-2660.

Research output: Contribution to journalArticle

Schölvinck, DW, Alvarez Herrero, L, Goto, O, Meijer, SL, Neuhaus, H, Schumacher, B, Bergman, JJGHM & Weusten, BLAM 2015, 'Efficacy and safety of a novel submucosal lifting gel used for endoscopic submucosal dissection: a study in a porcine model', Surgical Endoscopy and Other Interventional Techniques, vol. 29, no. 9, pp. 2651-2660. https://doi.org/10.1007/s00464-014-3985-9
Schölvinck, D. W. ; Alvarez Herrero, L. ; Goto, O. ; Meijer, S. L. ; Neuhaus, H. ; Schumacher, B. ; Bergman, J. J G H M ; Weusten, B. L A M. / Efficacy and safety of a novel submucosal lifting gel used for endoscopic submucosal dissection : a study in a porcine model. In: Surgical Endoscopy and Other Interventional Techniques. 2015 ; Vol. 29, No. 9. pp. 2651-2660.
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abstract = "Background and study aims: Endoscopic submucosal dissection (ESD) is technically demanding. A viscous gel for submucosal lifting might induce mechanical submucosal dissection facilitating easier and safer ESD. Methods: In 12 female pigs (median 64 kg), ESDs of simulated lesions were performed at the posterior wall and greater curvature in the gastric body (one ESD per location) with randomly assigned injection fluids: gel or control fluid (0.9 {\%} saline with hydroxypropyl methylcellulose 3 mg/ml [7:1] and indigo carmine droplets). Additionally, 10 cc gel was injected into the submucosa at the anterior wall without ESD to assess effects of inappropriate injection. Pigs were euthanized at day 0, 3 or 28. In four additional pigs (euthanized day 3 or 28) 10 cc gel was injected into the muscularis propria (MP) after four endoscopic mucosal resections in the gastric body. Results: Both fluid groups showed equal ESD-procedure times (28 [gel] vs. 26 min [control]) and complications. Gel-ESDs required less accessory interchanges (3.5 vs. 5.5; p = 0.01). Mechanical dissection after circumferential incision was achieved in 25 {\%} of gel-ESDs; none in control-ESDs. The severity of inflammation and fibrosis was equal in both fluid groups. Normal architecture and vital mucosa were found after inappropriate submucosal injection. MP-injections resulted in one transmural hematoma (day 3), and intramuscular encapsulation in 25 {\%} of the sites (day 28). Limitations: A pig’s stomach differs from the human stomach. Conclusions: The mechanical dissection properties of the gel may reduce the need for submucosal dissection during ESD. The gel is safe when advertently injected in the submucosa and MP. The porcine model appeared suboptimal to evaluate the true mechanical dissection properties of the gel.",
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