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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02189226
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Duration (Months): 14.6
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Early Gastric Cancer	Device: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Jan 20, 2015
• Actual Study Completion Date: Jan 20, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: probe-based confocal laser endomicroscopy (pCLE) group	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.
Active Comparator: chromoendoscopy (CE) group	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.

Outcome Measures

Primary Outcome Measures

1. Complete resection rate [One week after ESD]

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

Secondary Outcome Measures

1. Horizontal cut end-positive [Within the first 30 days after ESD]

2. vertical cut end-positive [Within the first 30 days after ESD]

3. procedure time [1 day]

4. adverse event [Within the first 30 days after ESD]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02189226
• Other Study ID Numbers: 1-2013-0009
• First Posted: Jul 14, 2014
• Last Update Posted: Apr 1, 2019
• Last Verified: Dec 1, 2015

• Keywords provided by Yonsei University: probe-based confocal laser endomicroscopy (pCLE), early gastric cancer (EGC), endoscopic submucosal dissection (ESD), margin
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Apr 1, 2019