Usefulness of the clip-flap method of endoscopic submucosal dissection: A randomized controlled trial.

AIM: To prospectively investigate the efficacy and safety of clip-flap assisted endoscopic submucosal dissection (ESD) for gastric tumors.

METHODS: From May 2015 to October 2016, we enrolled 104 patients with gastric cancer or adenoma scheduled for ESD at Shiga University of Medical Science Hospital. We randomized patients into two subgroups using the minimization method based on location of the tumor (upper, middle or lower third of the stomach), tumor size (< 20 mm or > 20 mm) and ulcer status: ESD using an endoclip (the clip-flap group) and ESD without an endoclip (the conventional group). Therapeutic efficacy (procedure time) and safety (complication: Gastrointestinal bleeding and perforation) were assessed.

RESULTS: En bloc resection was performed in all patients. Four patients had delayed bleeding (3.8%) and two had perforation (1.9%). No significant differences in en bloc resection rate (conventional group: 100%, clip flap group: 100%), curative endoscopic resection rate (conventional group: 90.9%, clip flap group: 89.8%, P = 0.85), procedure time (conventional group: 70.8 ± 46.2 min, clip flap group: 74.7 ± 53.3 min, P = 0.69), area of resected specimen (conventional group: 884.6 ± 792.1 mm2 , clip flap group: 1006.4 ± 1004.8 mm2 , P = 0.49), delayed bleeding rate (conventional group: 5.5%, clip flap group: 2.0%, P = 0.49), or perforation rate (conventional group: 1.8%, clip flap group: 2.0%, P = 0.93) were found between the two groups. Less-experienced endoscopists did not show any differences in procedure time between the two groups.

CONCLUSION: For patients with early-stage gastric tumors, the clip-flap method has no advantage in efficacy or safety compared with the conventional method.