Prospective multicenter trial of the cryoballoon ablation system for superficial esophageal squamous cell carcinoma on post-endoscopic resection scars: a CRYO-SCAR study (EPOC1902).
Gastrointest Endosc
; 100(3): 429-437, 2024 Sep.
Article
en En
| MEDLINE
| ID: mdl-38431103
ABSTRACT
BACKGROUND AND AIMS:
Endoscopic resection is a minimally invasive treatment for superficial esophageal squamous cell carcinoma (SESCC). Post-endoscopic resection scars complicate en-bloc resection, even with advanced techniques, such as endoscopic submucosal dissection. The cryoballoon ablation system (CBAS) effectively manages Barrett's esophagus but has limited evidence in SESCC treatment, particularly on post-endoscopic resection scars. This study aimed to evaluate the efficacy and safety of the CBAS for treating SESCC on post-endoscopic resection scars.METHODS:
This prospective study was conducted at 2 tertiary referral centers in Japan in patients endoscopically diagnosed with T1a SESCC on the post-endoscopic resection scar. Focal CBAS was used for cryoablation, with specific criteria for lesion selection and treatment method. The primary endpoint was the rate of local complete response (L-CR) of the primary lesion 48 weeks after the first cryoablation as evaluated by an independent central evaluation committee.RESULTS:
From October 2020 to October 2021, 15 patients with 17 lesions underwent cryoablation, with 2 requiring repeat cryoablation. The L-CR rate for primary and all lesions evaluated by the central evaluation committee was 100%. The endoscopist's evaluation was consistent with these results. The median procedure time was 9 minutes. Eight patients experienced no pain, and the highest pain score reported on a numeric rating scale from 1 to 10 was 3. The technical success rate was 94.7% (18/19). Throughout the median follow-up period of 14.3 months, recurrences, deaths, or severe treatment-related adverse events were not reported.CONCLUSIONS:
CBAS is a potentially safe and effective approach for SESCC on post-endoscopic resection scars and represents an encouraging alternative to traditional endoscopic treatments. (Clinical trial registration numbers NCT03097666 and jRCT1080225331.).
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Neoplasias Esofágicas
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Cicatriz
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Criocirugía
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Resección Endoscópica de la Mucosa
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Carcinoma de Células Escamosas de Esófago
Límite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Gastrointest Endosc
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Gastrointest. endosc
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Gastrointestinal endoscopy
Año:
2024
Tipo del documento:
Article
País de afiliación:
Japón