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

NCT ID: NCT02189226

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-01-20

Brief Summary

The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).

Conditions

Early Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

probe-based confocal laser endomicroscopy (pCLE) group

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

chromoendoscopy (CE) group

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Consecutive patients diagnosed as EGC and treated by ESD with following criteria:1) Differentiated mucosal cancer without ulcer 2) Differentiated mucosal cancer with ulcer, ≤ 3 cm 3) Differentiated minute (<500 μm) submucosal invasive cancer, ≤ 3 cm 4) Undifferentiated mucosal cancer without ulcer, ≤ 2 cm
• Consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of EGC and treated by ESD

Exclusion Criteria

• Coagulopathy : International normalized ratio [INR] > 1.5 or platelet count <50,000 cell/cubic millimeter)
• Impaired renal function : Cr > 1.2 mg/dL
• Pregnancy or breast-feeding
• Age < 20 years
• Allergy to fluorescein dye
• Inability to provide informed consent

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2013-0009

Identifier Type: -

Identifier Source: org_study_id