Elsevier

Gastrointestinal Endoscopy

Volume 78, Issue 5, November 2013, Pages 704-710
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
A phase II study of endoscopic submucosal dissection for superficial esophageal neoplasms (KDOG 0901)

https://doi.org/10.1016/j.gie.2013.04.182Get rights and content

Background

Most previous studies of endoscopic submucosal dissection (ESD) for superficial esophageal neoplasms were retrospective; prospective studies are scant.

Objective

To prospectively assess the efficacy and safety of ESD for superficial esophageal neoplasms.

Design

Phase II study.

Setting

University hospital.

Patients

Fifty-two patients (median age 68 years; 48 men) who had a histologic diagnosis of superficial esophageal cancer without metastasis on CT or high-grade intraepithelial neoplasia (HGIN) were enrolled from April 2009 through November 2011.

Intervention

ESD was used to treat 56 lesions. All procedures were done by 4 endoscopists who each had previously performed ESD in more than 100 patients with gastric tumors.

Main Outcome Measurements

The primary endpoint was the R0 resection rate, and secondary endpoints were the safety and the rate of accurately diagnosing tumor depth on endoscopic examination.

Results

The median treatment time was 69 minutes (24-168 minutes). The histopathologic diagnosis was squamous cell carcinoma in 49 lesions, HGIN in 5, and tubular adenocarcinoma in 2. The en bloc resection rate and R0 resection rate were 100% and 94.6%, respectively. The rates of adverse events during ESD and after ESD were 22.2% and 53.8%, respectively, but most events were mild. One patient (1.9%) had mediastinal emphysema without perforation. The rate of accurately diagnosing tumor depth on endoscopic examination was 76.8%.

Limitations

Single-center, nonrandomized study.

Conclusion

Our study showed that ESD was an effective and relatively safe treatment for superficial esophageal neoplasms. ESD may be a useful treatment option for superficial esophageal neoplasms in hospitals with endoscopists who are experts in performing ESD for gastric tumors. (Clinical trial registration number: UMIN000002047.)

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.

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