A phase II study of endoscopic submucosal dissection for superficial esophageal neoplasms (KDOG 0901).
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.).
['Higuchi|Katsuhiko|K|', 'Tanabe|Satoshi|S|', 'Azuma|Mizutomo|M|', 'Katada|Chikatoshi|C|', 'Sasaki|Tohru|T|', 'Ishido|Kenji|K|', 'Naruke|Akira|A|', 'Katada|Natsuya|N|', 'Koizumi|Wasaburo|W|']
D000230:Adenocarcinoma D000368:Aged D000369:Aged, 80 and over D002278:Carcinoma in Situ D002294:Carcinoma, Squamous Cell D015331:Cohort Studies D004210:Dissection D004938:Esophageal Neoplasms D004945:Esophagoscopy D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D009092:Mucous Membrane D060787:Neoplasm Grading D011446:Prospective Studies D016896:Treatment Outcome
endoscopic submucosal dissection superficial esophageal neoplasm ESD high-grade intraepithelial neoplasia HGIN CO(2) IT NBI SEN SM1 SM2 carbon dioxide deeper submucosal invasion (≥200 μm below the muscularis mucosae) insulated-tip minute submucosal invasion (<200 μm below the muscularis mucosae) narrow-band imaging