An open-label, prospective trial of cryospray ablation for Barrett's esophagus high-grade dysplasia and early esophageal cancer in high-risk patients

doi:10.1016/j.gie.2009.02.006

Gastrointestinal Endoscopy

Volume 70, Issue 4, October 2009, Pages 635-644

https://doi.org/10.1016/j.gie.2009.02.006 Get rights and content

Background

Endoscopic ablation of Barrett's esophagus (BE) is a treatment option for patients with high-grade dysplasia (HGD) and intramucosal carcinoma (IMCA).

Objective

To assess the safety and efficacy of a unique noncontact method of liquid nitrogen cryoablation as measured by histologic response rate and cancer-free survival.

Design

Single-center, nonrandomized cohort study.

Setting

Referral center, conducted between September 2005 and September 2008.

Patients

Patients with BE and HGD or IMCA who were deemed inoperable or who refused esophagectomy. Age, length of BE, and previous ablation were not exclusion criteria.

Intervention

Cryoablation every 6 weeks until endoscopic resolution. EMR was used for pathologic staging of nodular areas before cryoablation and focal residual areas during the follow-up period.

Main Outcome Measurements

Histologic response was defined by the worst pathology obtained at any level of the esophagus or gastric cardia in 1 of 3 categories: (1) incremental = absence of HGD and IMCA in all biopsy specimens, (2) partial = residual IMCA with absence of any dysplasia, and (3) complete = absence of any intestinal metaplasia or dysplasia.

Results

Thirty patients underwent ablation; 9 had undergone previous ablation or mucosectomy. Twenty-seven of 30 patients (90%) had downgrading of pathology stage after treatment. Elimination of cancer or downgrading of HGD at last follow-up was 68% for HGD and 80.0% for IMCA, with a median follow-up period of 12 months (25th percentile, 6; 75th percentile, 24). Minor adverse events included mild pain (n = 7), a low incidence of mild strictures (n = 3), and lip ulcer (n = 1). One major adverse event (perforation) in a patient with Marfan syndrome occurred with the prototype system. During follow-up, 3 of 6 patients with complete response had recurrence of dysplasia or cancer in the gastric cardia.

Limitations

A nonrandomized, single-center study with a heterogeneous cohort of patients.

Conclusions

Patients with BE and HGD or IMCA have a positive response to endoscopic cryotherapy at 1-year follow-up.

Section snippets

Patients and methods

This study was a single-center, open-label study of high-risk, nonsurgical patients with BE-associated HGD or IMCA. The study was approved by the Cleveland Clinic institutional review board on September 16, 2005, and patients gave written informed consent. Patients were eligible for this study if they were either deemed high-risk patients for esophagectomy based on conditions such as severe heart disease (congestive heart failure), lung disease (chronic obstructive or restrictive disease),

Results

A total of 39 patients were enrolled, and 37 patients were treated with cryoablation between September 2005 and March 2007. Two patients were excluded because of retained food and lack of BE with dysplasia after staging EMR after enrollment. Five patients with invasive disease (T1sm or higher) and 1 with squamous cell cancer were treated under the protocol, and all tolerated cryoablation without side effects. One patient was excluded from the analysis because he was lost to follow-up

Discussion

Ablation of BE with HGD or IMCA has been reported with Nd:YAG¹⁷ and KTP lasers,⁸ multipolar electrocoagulation,¹⁸ PDT with porfimer sodium,¹⁹ 5-aminolevulinic acid⁵ or hematoporphyrin derivative,²⁰ APC,10, 21 ultrasonic intraluminal ablation,²² and, more recently, RFA.11, 23 These techniques have achieved mucosal ablation with variable success but are hampered by inherent disadvantages. PDT is the first ablation method with a specific indication for BE with HGD and has the majority of long-term

Acknowledgment

We thank Erinn Downs-Kelly, DO, and Mary Bronner, MD, for expert review of pathology specimens and photomicrographs.

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Cited by (138)

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Citation Excerpt :
There has been some suggestion that APC can be used for superficial SCC in the residual esophagus following esophagectomy.57 Cryoablation has been found to help in managing dysplastic Barrett’s esophagus.58,59 Cryoablation may allow sufficient depth of treatment to treat nodular areas in Barrett’s esophagus, but endoscopic resection in these cases is generally preferable so that accurate staging can be performed to identify patients who may require additional treatment for potential lymph node metastasis.
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Barrett’s esophagus, sensation and reflux
2019, Clinical and Basic Neurogastroenterology and Motility
In this chapter, we explore the relationship between gastroesophageal reflux disease (GERD) and Barrett’s esophagus (BE), the only known premalignant condition to esophageal adenocarcinoma. We will discuss typical and atypical symptomatology of GERD and how that is affected by the presence of BE, esophageal motility findings in BE patients and how that affects its pathogenesis, the role of non-acidic reflux, various diagnostic tools that can be used by the clinician, and finally shed light on advances in management options of GERD (medical and surgical) as well as ablative therapies in BE.
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2018, Gastrointestinal Endoscopy
A small but significant proportion of patients with Barrett’s esophagus (BE) have persistent dysplasia or intestinal metaplasia (IM) after treatment with radiofrequency ablation (RFA). Cryotherapy is a cold-based ablative modality that is increasingly being used in this setting. We aimed to better understand the efficacy of second-line cryotherapy in patients with BE who have persistent dysplasia or IM after RFA by conducting a systematic review and meta-analysis.
We performed a systematic literature search of Pubmed, EMBASE, and Web of Science through September 1, 2017. Articles were included for meta-analysis based on the following inclusion criteria: ≥5 patients with BE treated with RFA had persistent dysplasia or IM; they subsequently underwent ≥1 session of cryotherapy with follow-up endoscopy; the proportions of patients achieving complete eradication of dysplasia (CE-D) and/or IM (CE-IM) were reported. The main outcomes were pooled proportions of CE-D and CE-IM by using a random effects model.
Eleven studies making up 148 patients with BE treated with cryotherapy for persistent dysplasia or IM after RFA were included. The pooled proportion of CE-D was 76.0% (95% confidence interval [CI] 57.7-88.0), with substantial heterogeneity (I² = 62%). The pooled proportion of CE-IM was 45.9% (95% CI, 32.0-60.5) with moderate heterogeneity (I² = 57%). Multiple preplanned subgroup analyses did not sufficiently explain the heterogeneity. Adverse effects were reported in 6.7% of patients.
Cryotherapy successfully achieved CE-D in three fourths and CE-IM in half of patients with BE who did not respond to initial RFA. Considering its favorable safety profile, cryotherapy may be a viable second-line option for this therapeutically challenging cohort of patients with BE, but higher-quality studies validating this remain warranted.

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: DISCLOSURE: The following author received research support for this study from CSA Medical Inc: J. A. Dumot. All other authors disclosed no financial relationships relevant to this publication.

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Original articleClinical endoscopyAn open-label, prospective trial of cryospray ablation for Barrett's esophagus high-grade dysplasia and early esophageal cancer in high-risk patients

Background

Objective

Design

Setting

Patients

Intervention

Main Outcome Measurements

Results

Limitations

Conclusions

Section snippets

Patients and methods

Results

Discussion

Acknowledgment

Gastrointest Endosc

Gastroenterology

Gastrointest Endosc

Gastroenterology

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Original article
Clinical endoscopy
An open-label, prospective trial of cryospray ablation for Barrett's esophagus high-grade dysplasia and early esophageal cancer in high-risk patients