GASTROINTESTINAL ENDOSCOPY Volume 78, No. 5 : 2013 F1 김태영 Katsuhiko Higuchi, MD, PhD, Satoshi Tanabe, MD, PhD, Mizutomo Azuma, MD, PhD, Chikatoshi Katada, MD, PhD, Tohru Sasaki, MD, PhD,Kenji Ishido, MD, PhD, Akira Naruke, MD, Natsuya Katada, MD, PhD, Wasaburo Koizumi, MD, PhD Sagamihara, Japan

INTRODUCTION EMR of superficial esophageal cancer - complete resection 23% to 51.8% - local recurrence rate 6% to 20% ESD of superficial esophageal neoplasms (SENs) - complete resection 78% to 95% - local recurrence rate expected to be lower Problems of ESD - technical difficulty, a prolonged treatment time, the risk of adverse events

PATIENTS AND METHODS -Objectives, efficacy, and safety criteria Primary objective - complete resection Resection time - time of marking to the collecting the specimen Secondary objectives : - incidence of adverse events - the rate of accurately diagnosing tumor depth

PATIENTS AND METHODS -Objectives, efficacy, and safety criteria Adverse events - classified to during or after ESD - National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

PATIENTS AND METHODS -Patients ~ , 52 patients with SENs Inclusion criteria (1) age: 20 to 80 yrs, ECOG 0 to 2 (2) SqCC or adeno Ca. or HGIN, 2 synchronous lesions (3) an estimated depth of invasion : to SM1 (<200µm) (4) no evidence of LN or distant metastasis on CT (5) no history of surgery or radiotherapy (6) WBC 3000 to 12,000/mm 3, Hgb ≥ 8.0 mg/dL, PLT ≥ 10 만 /mm 3, AST, ALT ≤ 100 IU/L, Cr ≤ 2.0 mg/dL Bilirubin ≤ 2.0 mg/dL, normal electrocardiogram result (7) written informed consent

PATIENTS AND METHODS -Patients Exclusion criteria (1) impossible interruption of antithrombotic therapy (2) active malignancy at another site (3) pregnant, breast feeding (4) the patient had a mental disorder (5) continuous systemic treatment with steroids (6) active bacterial or fungal infections (7) a history of MI or unstable angina (< 3month) (8) poorly controlled DM,HTN (9) respiratory disease requiring sustained oxygen inhalation was present (10) other conditions considered by the attending

PATIENTS AND METHODS -ESD procedure 4 endoscopists ( ≥ 100 ESD with gastric tumors) sedation: MDZ 4mg, pethidine 35mg, propofol video endoscope GIF-H260Z, GIF-Q260J a needle-knife (KD-1L-1; Olympus) hook-knife (KD-620LR; Olympus) IT knife-2 (KD-611L; Olympus) coagrasper (FD-410LR; Olympus) electrical surgical unit (VIO 300D,Erbe) submucosal injection: 200 mL of 10% glycerin + indigocarmine + 1 mg epinephrine ± hyaluronic acid (1:1 ratio )

IT-2 51/56 Hook 5/56

PATIENTS AND METHODS -ESD procedure estimate the depth of invasion (white-light endoscopy, magnifying endoscopy with NBI) Iodine staining (1.5% iodine solution) Marking, injection Hemostasis by hemostatic forcep Muscle exposure, perforation - hemoclip, Insufflation with CO2

PATIENTS AND METHODS -Histopathologic evaluation fixed in formalin, cut into 2-mm–wide strips embedded in paraffin diagnosis according to the Japanese Classification of Esophageal Carcinoma The depth of tumor invasion - intraepithelial ; lamina propria mucosae muscularis mucosae; SM1 (<200 mm) SM2(≥200 mm) Complete resection : en bloc + R0 resection Incomplete resection : tumor-positive margins damaged margin

PATIENTS AND METHODS -Additional treatment after ESD the depth of invasion : from intraepithelial to SM1 negative resection margin negative vascular invasion - IF NOT, additional chemoradiotherapy recommened

PATIENTS AND METHODS -Follow-up EGD was performed at 2, 6, Then, every 6months Iodine-staining endoscopy was used CT every 6 months (MM invasion or SM cancer)

PATIENTS AND METHODS -Statistical analysis Known EMR complete resection rate 51.8% Expected ESD complete resection rate 80 % Assuming an alpha error of 0.05 a beta error of 0.10 The target number of patients was set at 50 All quantitative data presented as medians.

RESULTS -Clinicopathologic features

RESULTS -Clinical outcomes-1 Incomplete resection 3 : 1-vertical(+), 2-horizontal (+)

RESULTS -Clinical outcomes-2 Accuracy : 76.8% (43/56)

RESULTS -Adverse events Musle exposure 11

RESULTS -Adverse events ≥3/4 circumference dissected 4/5 (80%)

RESULTS -Additional treatment 3 patients (2 : SM2 cancer and 1 : vertical margin +) All 3 patients received chemoradiotherapy ( 5-FU and cisplatin with concomitant radiotherapy)

CONCLUSIONS ESD was an effective and relatively safe treatment for superficial esophageal neoplasms (SENs) ESD may be a useful treatment option for SENs in hospitals with endoscopists who are experts in performing ESD for gastric tumors