Efficacy of innovative polyglycolic acid sheet device delivery station system: a randomized prospective study.

BACKGROUND

Although there have been several reports of treating large post-endoscopic submucosal dissection (ESD) ulcers by covering them with a polyglycolic acid sheet (PGAs), this approach presents problems regarding PGAs delivery. This study assessed the usefulness of a device delivery station system (DDSS) to evaluate the appropriate and rapid PGAs coating method with DDSS.

METHODS

Thirty-nine of 41 patients who were diagnosed with early gastric cancer over 20 mm in diameter and pathologically diagnosed with well-differentiated adenocarcinoma were randomly allocated to the following two groups according to delivery method: the conventional PGAs delivery group (C group) (n = 19) and the new DDSS group (DDSS group) (n = 20). The primary outcome was the coating area per minute in the C group and DDSS group (cm/min).

RESULTS

There were significant differences in the coating time (min), with values of 34.1 (15.0-60.7) vs. 16.85 (11.5-27.2) min for the C group and DDSS group, respectively (p = 0.001). There was also a significant difference in coating area per minute, with values of 0.261 (0.02-1.00) and 0.96 (0.173-2.06) cm/min for the C group and DDSS group, respectively (p = 0.001). There were four cases of post-ESD bleeding (1-7 days after ESD) in the C group compared with 0 in the DDSS group, which represented a significant difference (p = 0.030).

CONCLUSIONS

The DDSS was very useful for rapidly delivering and tightly attaching a PGAs to control post-ESD bleeding.

TRIAL REGISTRATION

University Hospital Medical Network (UMIN) 000026377.