Original articleClinical endoscopyA phase II study of endoscopic submucosal dissection for superficial esophageal neoplasms (KDOG 0901)
Section snippets
Objectives, efficacy, and safety criteria
The primary objective of the study was the rate of complete resection (R0 resection). En bloc resection was defined as single-piece resection of the neoplastic lesion as confirmed by endoscopic examination. Complete resection was defined as en bloc resection with histologically confirmed tumor-free margins. Resection time was defined as the interval from the time of marking the lesion to the time of collecting the specimen after resection.
Secondary objectives were the incidence of adverse
Clinicopathologic features
Patient and tumor characteristics are summarized in Table 1. A total of 52 patients (median age 68 years; 48 men) were enrolled, and 56 lesions were treated by ESD. Among the 42 patients who had some underlying disease, 9 were receiving antithrombotic therapy. Most lesions were located in the thoracic esophagus, but 3 lesions were located in the cervical esophagus and 4 lesions in the abdominal esophagus. The histopathologic diagnoses were squamous cell carcinoma in 49 lesions, HGIN in 5, and
Discussion
To our knowledge, this is the first phase II study to prospectively assess the efficacy and safety of ESD for SEN. The primary endpoint was successfully achieved, with an R0 resection rate of 94.6%. Adverse events were prospectively monitored and evaluated in detail by nurses and physicians. The rate of adverse events during ESD was 22.2%, but all adverse events were grade 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, and ESD was
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DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.