Trial reportGastrointestinal endoscopy2019
Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China.
Trial report in Gastrointestinal endoscopy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Study to Evaluate the Safety, Feasibility and Efficacy of the Coldplay CryoBalloon Focal Ablation System for the Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer
Who cites it
5 citing papers in PubMed.
- Applications of cryotherapy in premalignant and malignant esophageal disease: Preventing, treating, palliating disease and enhancing immunogenicity?World journal of gastrointestinal oncology · 2025Review
- Organ and function preservation in gastrointestinal cancer: Current and future perspectives on endoscopic ablation.World journal of gastrointestinal endoscopy · 2024Article
- Effective Palliative Treatment of Obstructive Metastatic Esophageal Squamous Cell Carcinoma for Nearly 2 Years With Liquid Nitrogen Cryoablation Alone.ACG case reports journal · 2024Article
- Article
- Endoscopic resection combined with the Cryoballoon focal ablation system in the porcine normal esophagus: a preclinical study.BMC gastroenterology · 2021Article
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Authors and funding
15 authors.
Funding
Abstract
BACKGROUND AND
aimsEsophageal 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.
methodsIn 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.
resultsWe 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.
conclusionsThe 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.).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.