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Efficacy and safety of a novel submucosal lifting gel used for endoscopic submucosal dissection: a study in a porcine model

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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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Abbreviations

EMR:

Endoscopic mucosal resection

ESD:

Endoscopic submucosal dissection

MBM:

Multiband mucosectomy

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Acknowledgments

The authors thank Elly van Zwol, Sanne Hackmann, Alwin Blankestijn, and Hester de Bruin for their biotechnical assistance. This study was supported by Cook Medical, Limerick, Ireland. Prof. J.J.G.H.M. Bergman is a consultant for Cook Medical and received speaker fees from Cook Medical. Prof. H. Neuhaus is a consultant for Cook Medical.

Disclosures

D.W. Scholvinck, L. Alvarez Herrero, O. Goto, S.L. Meijer, H. Neuhaus, B. Schumacher, J.J.G.H.M. Bergman, and B.L.A.M. Weusten have no conflicts of interest or financial ties to disclose.

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Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands

    D. W. Schölvinck, L. Alvarez Herrero & B. L. A. M. Weusten

  2. Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, Netherlands

    D. W. Schölvinck, L. Alvarez Herrero, J. J. G. H. M. Bergman & B. L. A. M. Weusten

  3. Division of Research and Development for Minimally Invasive Treatment, Cancer Center, School of Medicine, Keio University, Tokyo, Japan

    O. Goto

  4. Department of Pathology, Academic Medical Center, Amsterdam, Netherlands

    S. L. Meijer

  5. Department of Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany

    H. Neuhaus

  6. Department of Internal Medicine and Gastroenterology, Elisabeth-Krankenhaus, Essen, Germany

    B. Schumacher

Authors
  1. D. W. Schölvinck
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  2. L. Alvarez Herrero
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  3. O. Goto
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  4. S. L. Meijer
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  5. H. Neuhaus
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  6. B. Schumacher
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  7. J. J. G. H. M. Bergman
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  8. B. L. A. M. Weusten
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Correspondence to D. W. Schölvinck.

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Schölvinck, D.W., Alvarez Herrero, L., Goto, O. et al. Efficacy and safety of a novel submucosal lifting gel used for endoscopic submucosal dissection: a study in a porcine model. Surg Endosc 29, 2651–2660 (2015). https://doi.org/10.1007/s00464-014-3985-9

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  • DOI: https://doi.org/10.1007/s00464-014-3985-9

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