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Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus

Authors

  • Bruce D. Greenwald,

    Corresponding author
    1. Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine and Greenebaum Cancer Center, Baltimore, Maryland;
      Bruce D. Greenwald, MD, Division of Gastroenterology and Hepatology, 22 South Greene Street, Rm N3W62, Baltimore, MD 21201-1595, USA. Email: bgreenwa@medicine.umaryland.edu
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  • John A. Dumot,

    1. Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio;
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  • J. David Horwhat,

    1. Gastroenterology Service, Department of Medicine, Walter Reed Army Medical Center, Washington, DC;
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  • Charles J. Lightdale,

    1. Division of Digestive and Liver Diseases, Columbia University Medical Center, New York, USA
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  • Julian A. Abrams

    1. Division of Digestive and Liver Diseases, Columbia University Medical Center, New York, USA
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  • Author contributions:

     GreenwaldHorwhatAbramsLightdaleDumot
    Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of dataXXXXX
    Drafting the article or revising it critically for important intellectual contentXXXXX
    Final approval of the version to be publishedXXXXX

Bruce D. Greenwald, MD, Division of Gastroenterology and Hepatology, 22 South Greene Street, Rm N3W62, Baltimore, MD 21201-1595, USA. Email: bgreenwa@medicine.umaryland.edu

SUMMARY

Endoscopic cryotherapy is a new technique for ablation of esophageal dysplasia and neoplasia. Preliminary studies have shown it to be safe and effective for this indication. The objective of this study is to characterize safety, tolerability, and efficacy of low-pressure liquid nitrogen endoscopic spray cryotherapy ablation in a large cohort across multiple study sites. Parallel prospective treatment studies at four tertiary care academic medical centers in the U.S. assessed spray cryotherapy in patients with Barrett's esophagus with or without dysplasia, early stage esophageal cancer, and severe squamous dysplasia who underwent cryotherapy ablation of the esophagus. All patients were contacted between 1 and 10 days after treatment to assess for side effects and complications of treatment. The main outcome measurement was the incidence of serious adverse events and side effects from treatment. Complete response for high-grade dysplasia (HGD) (CR-HGD), all dysplasia (CR-D), intestinal metaplasia (CR-IM) and cancer (CR-C) were assessed in patients completing therapy during the study period. A total of 77 patients were treated for Barrett's high-grade dysplasia (58.4%), intramucosal carcinoma (16.9%), invasive carcinoma (13%), Barrett's esophagus without dysplasia (9.1%), and severe squamous dysplasia (2.6%). Twenty-two patients (28.6%) reported no side effects throughout treatment. In 323 procedures, the most common complaint was chest pain (17.6%) followed by dysphagia (13.3%), odynophagia (12.1%), and sore throat (9.6%). The mean duration of any symptoms was 3.6 days. No side effects were reported in 48% of the procedures (155/323). Symptoms did not correlate with age, gender, diagnosis, or to treatment early versus late in the patient's or site's experience. Logit analysis showed that symptoms were greater in those with a Barrett's segment of 6 cm or longer. Gastric perforation occurred in one patient with Marfan's syndrome. Esophageal stricture developed in three, all successfully treated with dilation. In 17 HGD patients, cryotherapy produced CR-HGD, CR-D, and CR-IM of 94%, 88%, and 53%, respectively. Complete regression of cancer and HGD was seen in all seven patients with intramucosal carcinoma or stage I esophageal cancer. Endoscopic spray cryotherapy ablation using low-pressure liquid nitrogen in the esophagus is safe, well-tolerated, and efficacious.

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