Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status

NCT03449966 | Unknown DMC

• 1 other identifier: 4-2017-0770
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

\* single center, prospective study First, evaluate the lesion under the white light endoscopy (WLE) → IV fluorescein sodium 0.1mL/kg → evaluate the lesion under probe-based confocal laser microendoscopy → target biopsy under the pCLE → random biopsy under WLE

Conditions

Advanced Gastric Cancer; Neoadjuvant Chemotherapy; Palliative Chemotherapy

Keywords

pCLE; confocal; Advanced gastric cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• The percentage of remnant cancer cells in biopsy samples

  The percentage of remnant cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy

  within the first day after pCLE

Secondary Outcomes (1)

• pCLE findings of residual cancer cells after chemotherapy

  within the first day after pCLE

Study Arms (2)

Target biopsy under pCLE

EXPERIMENTAL

(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)

Device: Confocal group

Random biopsy at cancer lesion under WLE

ACTIVE COMPARATOR

WLE (GIF-HQ290, Olympus, Japan) group

Device: Control group

Interventions

Confocal group DEVICE

Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.

Also known as: pCLE group

Target biopsy under pCLE

Control group DEVICE

Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.

Random biopsy at cancer lesion under WLE

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Older than 20 years old and younger than 80 years old B. Patients who completed neoadjuvant chemotherapy with AGC C. Patients who underwent palliative chemotherapy with AGC

You may not qualify if:

• A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university of medical center

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Sang Kil Lee, MD

CONTACT

82-2-2228-1996; sklee@yuhs.ac

Study Design

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

Model Details: All procedures were performed with both WLE and pCLE. One patient underwent both WLE and pCLE. Target biopsy under pCLE and random biopsy at cancer lesion under WLE will be done for one patient. The proportion of remnant cancer cells in biopsy samples will be compared.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: February 20, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)