Abstract
BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is technically difficult for beginners. Few comparative studies of technical feasibility, efficacy, and safety using various devices have been reported. This study evaluated the feasibility, efficacy, and safety of ESD for EGC < 2 cm using grasping-type scissors forceps (GSF) or insulated-tip knife (IT2) for three resident endoscopists. PATIENTS AND METHODS: This was a randomized phase II study in a cancer referral center. A total of 108 patients with 120 EGCs were enrolled with the following characteristics: differentiated-type mucosal EGC, without ulcers or scars, < 2 cm (86 men, 22 women; median age 72 years). All lesions were stratified according to operator and tumor location (antrum or corpus), assigned randomly to two groups (GSF or IT2), and resected by ESD. Self-completion rate, complete resection rate, procedure time, and adverse events were evaluated as main outcome measures. RESULTS: There was no difference in self-completion rate between the IT2 group (77 %, 47/61, P = 0.187) and the GSF group (66 %, 37/56). Also, there were no differences in en bloc resection rate (98 %, 60/61 vs. 93 %, 52/56, P = 0.195) and adverse events (3.3 %, 2/61 vs. 7.1 %, 4/56, P = 0.424). Median (min [range]) procedure time in the IT2 group (47 [33 - 67], P = 0.003) was shorter than that in the GSF group (66 [40 - 100]). Limitations of this study were the small sample size and single center design. CONCLUSIONS: ESD with GSF did not show a statistically significant advantage in improvement of self-completion rate over IT2. ( STUDY REGISTRATION: UMIN 000005048).