Aims:
Globally, 80% of all esophageal cancers are squamous cell cancer (ESCC), arising from
squamous cell neoplasia (ESCN). Although patients with ESCC have poor prognosis, curative
endoscopic treatment can be performed for ESCN. ESCN mainly occurs in developing countries,
with limited endoscopic expertise and resources. Hence, an easy-to-use, low-cost treatment
would be of great value. The cryoballoon focal ablation system (CbFAS) is a novel
endoscopic ablation therapy that comprises a portable handle with a through-the-scope
catheter containing a conformable balloon. The balloon is simultaneously inflated
and cooled, resulting in ice patches of ± 2 cm2. CbFAS is easy to use and requires no capital equipment. We aimed to assess the safety,
tolerability and efficacy of CbFAS for eradicating ESCN.
Methods:
In this prospective trial, patients with one flat-type unstained lesion (USL) on Lugol's
chromoscopy, < 6 cm and < 50% of the circumference with moderate/high-grade intraepithelial
neoplasia (MGIN/HGIN) were enrolled. At baseline, the lesion was treated with side-by-side
ablations of 10 seconds. Safety phone calls were performed at days 2, 7 and 30. Follow-up
endoscopies with biopsies and retreatment for persisting lesions were performed at
3 month intervals. All patients underwent a 12-months endoscopy.
Results:
We enrolled 80 patients (59 MGIN, 21 HGIN) with a USL of median 3 (IQR 3 – 4)cm. Median
5 (4 – 7) side-by-side ablations were performed per patient, over a median ablation
time of 8 (5 – 10) minutes. After a single treatment, 70/78 patients (90%) exhibited
CR and 8/78 (10%) had residual USL and were retreated; all had CR 3 months later.
At 12 months, 76/78 patients (97%) exhibited CR whereas 2 patients had a recurrent
MGIN. No strictures or serious adverse events occurred. Post-procedure median VAS
was 1/0/0 at days2/7/30.
Conclusions:
Results of our prospective cohort study in China suggest that CbFAS of ESCN is safe,
well-tolerated, and highly effective in inducing endoscopic and histological remission.