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

NCT02189226 | Completed

• 1 other identifier: 1-2013-0009
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Keywords

probe-based confocal laser endomicroscopy (pCLE), early gastric cancer (EGC), endoscopic submucosal dissection (ESD), margin

Outcome Measures

Primary Outcomes (1)

• Complete resection rate

  Complete resection is defined as en bloc resection with negative horizontal, vertical margin and distance from marking dot to histologic margin will be measured.

  One week after ESD

Secondary Outcomes (4)

• Horizontal cut end-positive

  Within the first 30 days after ESD

• vertical cut end-positive

  Within the first 30 days after ESD

• procedure time

  1 day

• adverse event

  Within the first 30 days after ESD

Study Arms (2)

probe-based confocal laser endomicroscopy (pCLE) group

EXPERIMENTAL

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

chromoendoscopy (CE) group

ACTIVE COMPARATOR

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

Interventions

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Margins of Excision

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: November 1, 2013
• Primary Completion: January 20, 2015
• Study Completion: January 20, 2015
• Last Updated: April 1, 2019

Record last verified: 2015-12

Locations

KR (1)