Background and Aims
Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to
cancer. Current treatment options, endoscopic mucosal resection (EMR) or submucosal
dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS)
is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability,
and efficacy of CbFAS for eradication of ESCN.
Methods
In this single-center prospective trial in China, patients with 1 flat unstained lesion
(USL) on Lugol chromoendoscopy that contained moderate- or high-grade intraepithelial
neoplasia (MGIN or HGIN, respectively) were enrolled. CbFAS was performed using side-by-side
applications of 10 seconds, treatment was repeated at 3-month intervals until a complete
response (CR) was established. The response at 12 months was the primary trial endpoint.
Safety phone calls were performed at 2, 7, and 30 days after the initial CbFAS.
Results
We enrolled 80 patients (59 MGIN, 21 HGIN) with a median USL length of 3 cm (interquartile
range [IQR], 3-4). Seventy-nine received treatment, with a median of 5 side-by-side
applications (IQR, 4-7) per patient over a median of 8 minutes (IQR, 5-10). After
a single treatment, 70 of 78 patients (90%) exhibited CR, and 1 was lost to follow-up.
The other 8 with persisting USLs were retreated, and all achieved CR after this second
treatment. At 12 months after the initial CbFAS, 76 of 78 patients (97%) exhibited
CR and 2 (3%) had recurrent MGIN. No strictures or serious adverse events occurred.
Four patients developed self-limiting mucosal lacerations on balloon inflation. The
postprocedure median pain score was 1 of 10 (IQR, 0-2) at day 2 and 0 (0-0) at days
7 and 30.
Conclusions
The results suggest that the CbFAS is safe, well tolerated, and effective in inducing
endoscopic and histologic remission in patients with ESCN of limited size. (Clinical
trial registration number: NCT02605759.)
Abbreviations:
CbFAS (cryoballoon focal ablation system), CR (complete response), ESCC (esophageal squamous cell carcinoma), ESCN (esophageal squamous cell neoplasia), ESD (endoscopic submucosal dissection), HGIN (high-grade intraepithelial neoplasia), IQR (interquartile range), LGIN (low-grade intraepithelial neoplasia), MGIN (moderate-grade intraepithelial neoplasia), RFA (radiofrequency ablation), TA (treatment area), USL (unstained lesion)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Gastrointestinal EndoscopyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012.Int J Cancer. 2015; 136: E359-E386
- Global incidence of oesophageal cancer by histological subtype in 2012.Gut. 2015; 64: 381-387
- Squamous dysplasia—the precursor lesion for esophageal squamous cell carcinoma.Cancer Epidemiol Biomarkers Prev. 2013; 22: 540-552
- Mucosal iodine staining improves endoscopic visualization of squamous dysplasia and squamous cell carcinoma of the esophagus in Linxian, China.Cancer. 1998; 83: 220-231
- Squamous esophageal histology and subsequent risk of squamous cell carcinoma of the esophagus. A prospective follow-up study from Linxian, China.Cancer. 1994; 74: 1686-1692
- Histological precursors of oesophageal squamous cell carcinoma: results from a 13 year prospective follow up study in a high risk population.Gut. 2005; 54: 187-192
- Efficacy and safety of endoscopic submucosal dissection for superficial squamous esophageal neoplasia: a meta-analysis.Dig Dis Sci. 2014; 59: 1862-1869
- Endoscopic submucosal dissection is superior to conventional endoscopic resection as a curative treatment for early squamous cell carcinoma of the esophagus (with video).Gastrointest Endosc. 2010; 72: 255-264
- Mechanisms of tissue injury in cryosurgery.Cryobiology. 1998; 37: 171-186
- Treatment of Barrett's esophagus with a novel focal cryoablation device: a safety and feasibility study.Endoscopy. 2015; 47: 1106-1112
- Nitrous oxide cryotherapy for treatment of esophageal squamous cell neoplasia: initial multicenter international experience with a novel portable cryoballoon ablation system (with video).Gastrointest Endosc. 2018; 87: 574-581
- Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China.GIE. 2019; 89: 736-748.e2
- Radiofrequency ablation of esophageal lesions and recurrent fever.Gastrointest Endosc. 2012; 75: 926-927
- Risk factors of electrocoagulation syndrome after esophageal endoscopic submucosal dissection.World J Gastroenterol. 2018; 24: 1144-1151
- Mediastinal emphysema after esophageal endoscopic submucosal dissection: its prevalence and clinical significance.Dig Endosc. 2011; 23: 221-226
- High power setting argon plasma coagulation for the eradication of Barrett's esophagus.Am J Gastroenterol. 2000; 95: 1661-1668
- Significance of involvement by squamous cell carcinoma of the ducts of esophageal submucosal glands. Analysis of 201 surgically resected superficial squamous cell carcinomas.Cancer. 2000; 89: 248-254
- Is it justified to ablate flat-type esophageal squamous cancer? An analysis of endoscopic submucosal dissection specimens of lesions meeting the selection criteria of radiofrequency studies.Gastrointest Endosc. 2014; 80: 995-1002
- Outcomes from a prospective trial of endoscopic radiofrequency ablation of early squamous cell neoplasia of the esophagus.Gastrointest Endosc. 2011; 74: 1181-1190
- Endoscopic radiofrequency ablation for early esophageal squamous cell neoplasia: report of safety and effectiveness from a large prospective trial.Endoscopy. 2015; 47: 398-408
- Radiofrequency ablation for the endoscopic eradication of esophageal squamous high grade intraepithelial neoplasia and mucosal squamous cell carcinoma.Endoscopy. 2011; 43: 282-290
- Multimodal endoscopic therapy for multifocal intraepithelial neoplasia and superficial esophageal squamous cell carcinoma—a case series.Endoscopy. 2011; 43: 360-364
Article Info
Publication History
Published online: March 25, 2019
Accepted:
March 3,
2019
Received:
November 5,
2018
Footnotes
DISCLOSURE: All authors received research support from C2 Therapeutics, Inc. This study was also supported by the National Key R&D Program of China and CAMS Innovation Fund for Medical Sciences (Dr Ke).
If you would like to chat with an author of this article, you may contact Dr Ke at [email protected] .
Identification
Copyright
© 2019 by the American Society for Gastrointestinal Endoscopy
ScienceDirect
Access this article on ScienceDirectLinked Article
- The Ice Age reborn?Gastrointestinal EndoscopyVol. 90Issue 2
- PreviewEsophageal cancer is the sixth most common cause of cancer-related death worldwide, with esophageal squamous cell cancer (ESCC) being the dominant variety, particularly in developing countries.1 In China, where up to half of all cases occur, ESCC is the fourth leading cause of cancer death.2 Given the high prevalence of this disease in North Central China, an endoscopic screening program has been initiated in this high-risk region, with resultant decreases in cumulative incidence and ESCC-related death.
- Full-Text
- Preview
