Skip to main content
Log in

Single-Step Treatment with Limited Endoscopic Resection and Cryoballoon Ablation Is Feasible and Safe in an Esophageal Porcine Model

  • Original Article
  • Published:
Digestive Diseases and Sciences Aims and scope Submit manuscript

Abstract

Background

Treatment of Barrett’s neoplasia consists of two steps: endoscopic resection of visible lesions with subsequent ablation of remaining Barrett’s epithelium. However, extensive resection might hamper subsequent ablation due to stenosis. Combining both modalities in one session therefore offers potential advantages. Single-step treatment with radiofrequency ablation and resection appeared to be unsafe.

Aims

To evaluate feasibility and safety of single-step treatment with cryoballoon ablation and endoscopic resection.

Methods

Two single-step treatment regimens (15 treatment areas per regimen) were evaluated: (1) CRYO-EMR: four side-by-side focal ablations of 10 seconds followed by resection in the treated area; (2) EMR-CRYO: resection followed by 10-s ablation targeted on the resection wound. Primary outcome for both regimens was safety (perforations, clinically relevant strictures) and for CRYO-EMR also feasibility of resection and histopathological evaluation. Secondly, all CRYO-EMR and esophageal resection specimens were histopathologically evaluated.

Results

Six female pigs were treated (five treatment areas per animal). During 28 days of follow-up, no perforations or clinically relevant stenosis occurred. All resections were technically successful. For all CRYO-EMR specimens, histopathological evaluation was feasible with ablation effects present throughout all layers, while the architecture requisite for histopathological analysis remained intact. After 28 days, histopathological evaluation of the esophagi was performed. For EMR-CRYO, post-treatment fibrosis was present throughout the submucosa. The muscularis propria was the deepest layer involved for CRYO-EMR.

Conclusions

Single-step treatment with limited endoscopic resection and cryoballoon ablation is feasible and safe in a porcine model and justifies further evaluation in a clinical trial.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

Abbreviations

BE:

Barrett’s esophagus

CbFAS:

Cryoballoon focal ablation system

EMR:

Endoscopic mucosal resection

IQR:

Interquartile range

MBM:

Multi-band mucosectomy

RFA:

Radiofrequency ablation

SD:

Standard deviation

UES:

Upper esophageal sphincter

References

  1. Weusten B, Bisschops R, Coron E, et al. Endoscopic management of Barrett’s esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2017;49:191–198.

    Article  Google Scholar 

  2. van Vilsteren F, Alvarez Herrero L, Pouw R, et al. Radiofrequency ablation and endoscopic resection in a single session for Barrett’s esophagus containing early neoplasia: a feasibility study. Endoscopy. 2012;44:1096–1104.

    Article  Google Scholar 

  3. Barret M, Belghazi K, Weusten BLAM, Bergman JJGHM, Pouw RE. Single-session endoscopic resection and focal radiofrequency ablation for short-segment Barrett’s esophagus with early neoplasia. Gastrointest Endosc. 2016;84:29–36.

    Article  Google Scholar 

  4. Schölvinck D, Künzli H, Kestens C, et al. Treatment of Barrett’s esophagus with a novel focal cryoablation device: a safety and feasibility study. Endoscopy. 2015;47:1106–1112.

    Article  Google Scholar 

  5. Künzli H, Schölvinck D, Meijer S, Seldenrijk K, Bergman J, Weusten B. Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett’s esophagus islands. Endoscopy. 2016;49:169–175.

    Article  Google Scholar 

  6. Phoa KN, Pouw RE, Bisschops R, et al. Multimodality endoscopic eradication for neoplastic Barrett oesophagus: results of an European multicentre study (EURO-II). Gut. 2016;65:555–562.

    Article  CAS  Google Scholar 

  7. Li N, Pasricha S, Bulsiewicz WJ, et al. Effects of preceding endoscopic mucosal resection on the efficacy and safety of radiofrequency ablation for treatment of Barrett’s esophagus: results from the United States Radiofrequency Ablation Registry. Dis Esophagus. 2016;29:537–543.

    Article  CAS  Google Scholar 

  8. Pouw RE, Seewald S, Gondrie JJ, et al. Stepwise radical endoscopic resection for eradication of Barrett’s oesophagus with early neoplasia in a cohort of 169 patients. Gut. 2010;59:1169–1177.

    Article  Google Scholar 

  9. van Vilsteren FGI, Pouw RE, Seewald S, et al. Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett’s oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut. 2011;60:765–773.

    Article  Google Scholar 

  10. Probst A, Aust D, Märkl B, Anthuber M, Messmann H. Early esophageal cancer in Europe: endoscopic treatment by endoscopic submucosal dissection. Endoscopy. 2014;47:113–121.

    Article  Google Scholar 

  11. Chevaux J, Piessevaux H, Jouret-Mourin A, Yeung R, Danse E, Deprez P. Clinical outcome in patients treated with endoscopic submucosal dissection for superficial Barrett’s neoplasia. Endoscopy. 2014;47:103–112.

    Article  Google Scholar 

  12. Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus (with video). Gastrointest Endosc. 2018;88:438–446.e2.

    Article  Google Scholar 

  13. Schölvinck DW, Bergman JJGHM, Visser M, Weusten BLAM. Circumferential cryoablation in a strictured esophagus: a feasibility and dose-finding study in a porcine model after inducing stenosis by endoscopic mucosal resection. Dis Esophagus. 2016;29:528–536.

    Article  Google Scholar 

  14. Herrero LA, van Vilsteren FGI, Visser M, et al. Simultaneous use of endoscopic resection and radiofrequency ablation is not safe in an esophageal porcine model. Dis Esophagus Off J Int Soc Dis Esophagus. 2015;28:25–31.

    Article  Google Scholar 

  15. Shaheen NJ, Falk GW, Iyer PG, Gerson LB, American College of Gastroenterology. ACG clinical guideline: diagnosis and management of Barrett’s esophagus. Am J Gastroenterol. 2016;111:30–50.

    Article  CAS  Google Scholar 

  16. Schölvinck DW, Alvarez Herrero L, Visser M, Bergman JJGHM, Weusten BLAM. Effects of Lugol staining on stenosis formation induced by radiofrequency ablation of esophageal squamous epithelium: a study in a porcine model. Dis Esophagus Off J Int Soc Dis Esophagus. 2015;28:603–611.

    Article  Google Scholar 

  17. Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol. 2010;8:e1000412.

    Article  Google Scholar 

Download references

Acknowledgments

The authors thank Koen Vaessen, Nico Attevelt, and Hester de Bruin for their biotechnical assistance, Pentax Medical of America, for providing all materials required for CbFAS treatment free of charge and Olympus Nederland for providing endoscopy materials required for performing the endoscopic resections and placing an endoscopy trolley at the animal laboratory for the duration of the study free of charge.

Author information

Authors and Affiliations

Authors

Contributions

All authors were involved in conception and design of the study. AO and BW were involved in analyses, interpretation of the data, and drafting of the manuscript. All authors were involved in critical revision for intellectual content. All authors were involved in final approval of the manuscript.

Corresponding author

Correspondence to B. L. A. M. Weusten.

Ethics declarations

Conflict of interest

B.L.A.M. Weusten received financial support for IRB-approved studies from Pentax Medical. A. Overwater, L.A.A. Brosens, and G.J.A. Offerhaus have no conflicts of interest or financial ties to disclose.

Ethical statements

This study was approved by the Animal Welfare Body Utrecht after overall project approval by the Animal Experiment Committee. The study was conducted in accordance with the Experiments on Animals Act. All applicable international, national, and/or institutional guidelines for the care and use of animals were followed. All procedures performed were in accordance with the ethical standards of the institution at which the studies were conducted. The manuscript was written according to the ARRIVE guidelines on reporting of in vivo experiments in animals [17].

Scientific presentation

This study was presented as an ePoster Podium presentation during the ESGE Days on April 6, 2019, in Prague.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Video of both single-step treatment regimens (MP4 127491 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Overwater, A., Brosens, L.A.A., Offerhaus, G.J.A. et al. Single-Step Treatment with Limited Endoscopic Resection and Cryoballoon Ablation Is Feasible and Safe in an Esophageal Porcine Model. Dig Dis Sci 65, 3175–3183 (2020). https://doi.org/10.1007/s10620-020-06054-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10620-020-06054-3

Keywords

Navigation