Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection

NACompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

January 20, 2015

Study Completion Date

January 20, 2015

Conditions
Early Gastric Cancer
Interventions
DEVICE

Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)

Before ESD, the lesion will be observed either by pCLE or by CE to determine proximal and distal margin of the lesion. In the pCLE group, after injection of intravenous fluorescein, the lesion will be observed using a flexible confocal miniprobe. In the CE group, the lesion will be observed conventionally under white light after spraying indigocarmine directly via the forceps channel. Marking dots will be placed on both margins using needle knife. Then several dots will be marked on the surrounding normal mucosa 5 mm from the tumor with Argon plasma coagulation. After injection of saline solution with epinephrine into the submucosa, an initial cut will be made with needle knife outside the line of surrounding marks. An insulation-tipped (IT) knife will be inserted into initial cut, and electrosurgical current will be applied to complete the incision around the tumor. After the circumferential cut, the submucosa will be dissected with the IT knife.

Trial Locations (1)

120-752

Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT02189226 - Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection | Biotech Hunter | Biotech Hunter