Original article
Clinical endoscopy
Safety and efficacy of endoscopic spray cryotherapy for Barrett's esophagus with high-grade dysplasia

https://doi.org/10.1016/j.gie.2010.01.018Get rights and content

Background

Endoscopic ablation to treat Barrett's esophagus (BE) with high-grade dysplasia (HGD) is associated with a decreased incidence of esophageal adenocarcinoma. Endoscopic spray cryotherapy (CRYO) demonstrates promising preliminary data.

Objective

To assess the safety and efficacy of CRYO in BE with HGD.

Design

Multicenter, retrospective cohort study.

Setting

Nine academic and community centers; treatment period, 2007 to 2009.

Patients

Subjects with HGD confirmed by 2 pathologists. Previous EMR was allowed if residual HGD remained.

Interventions

CRYO with follow-up biopsies.

Main Outcome Measurements

Complete eradication of HGD with persistent low-grade dysplasia, complete eradication of all dysplasia with persistent nondysplastic intestinal metaplasia, and complete eradication of all intestinal metaplasia.

Results

Ninety-eight subjects (mean age 65.4 years, 83% male) with BE and HGD (mean length 5.3 cm) underwent 333 treatments (mean 3.4 treatments per subject). There were no esophageal perforations. Strictures developed in 3 subjects. Two subjects reported severe chest pain managed with oral narcotics. One subject was hospitalized for bright red blood per rectum. Sixty subjects had completed all planned CRYO treatments and were included in the efficacy analysis. Fifty-eight subjects (97%) had complete eradication of HGD, 52 (87%) had complete eradication of all dysplasia with persistent nondysplastic intestinal metaplasia, and 34 (57%) had complete eradication of all intestinal metaplasia. Subsquamous BE was found in 2 subjects (3%).

Limitations

Nonrandomized, retrospective study with no control group, short follow-up (10.5 months), lack of centralized pathology, and use of surrogate outcome for decreased cancer risk.

Conclusions

CRYO is a safe and well-tolerated therapy for BE and HGD. Short-term results suggest that CRYO is highly effective in eradicating HGD.

Section snippets

Study design and subjects

We performed a retrospective analysis of consecutive subjects with BE and HGD undergoing CRYO at 9 sites in the United States. Subjects with unifocal or multifocal HGD of any length were eligible. All pathological specimens demonstrating HGD were confirmed with a second histological analysis by an expert pathologist. Previous EMR or other previous endoscopic therapy was allowed if the results demonstrated no evidence of residual adenocarcinoma and residual HGD was present in the tubular

Results

A total of 98 subjects fulfilled criteria and were included in the study. Mean (SD) age was 65.4 (10) years, and 83% were male (Table 1). The baseline mean (SD) endoscopic length of BE was 5.3 (3.2) cm. Before enrollment in the study, 1 (1%) subject had undergone Nissen fundoplication. Two (2%) subjects were status post partial esophagectomy for HGD with recurrent HGD in the esophageal remnant. Fourteen (14%) subjects were status post some form of previous unsuccessful ablative therapy (2%

Discussion

Endoscopic ablation to eradicate HGD and induce reversion to squamous epithelium is a viable, esophagus-sparing treatment option for patients with BE and HGD. Multiple methods of endoscopic ablation have been developed. Each method differs in mechanism and effectiveness of ablation, side effects, and cost. Our retrospective analysis of subjects with HGD treated with CRYO at 9 institutions, the largest reported experience with this technique to date, suggests that CRYO is associated with a

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DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: N.J. Shaheen: Grant from, consultant for, and advisory committee member of CSA Medical; grant from BÂRRX Medical Inc. B.D. Greenwald: Consultant for and advisory committee member of CSA Medical. J.A. Dumot: Consultant for and advisory committee member of CSA Medical. N.S. Nishioka: Research support from CSA Medical. H.C. Wolfsen: Research support from CSA Medical; research support from BÂRRX Medical Inc. K.K. Wang: Research support from CSA Medical; research support from BÂRRX Medical Inc. M.H. Johnston: Research support from CSA Medical. J.S. Barthel: Research support from CSA Medical. C.J. Lightdale: Advisory committee member of CSA Medical. All other authors disclosed no financial relationships relevant to this publication. This study was funded in part with a grant from CSA Medical, makers of the spray cryotherapy device. Dr. Peery is supported by a grant from the National Institutes of Health (T32 DK 07634). Statistical analysis and data management were also supported by a grant from the National Institutes of Health (P30 DK034987). Dr. Abrams is supported in part by a K07 award from the National Cancer Institute (CA 132892).

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