Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type

Summary

This multi-center, randomized controlled trial is designed to evaluate clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication compared with surgery.

Conditions

• Stomach Cancer
• Undifferentiated Type
• Expanded Indication of Endoscopic Resection

Interventions

PROCEDURE

Endoscopic submucosal dissection

Endoscopic submucosal dissection by a endoscopist using endoscopic devices

PROCEDURE

Surgery

Gastrectomy with lymph node dissection by a surgeon

Sponsors & Collaborators

• Seoul St. Mary's Hospital, The Catholic University

  collaborator UNKNOWN

• Chilgok Kyungpook National University Hospital

  collaborator UNKNOWN

• Pusan National University Hospital

  collaborator OTHER

• Samsung Medical Center, Sungkyunkwan University School of Medicine

  collaborator UNKNOWN

• Severance Hospital, Yonsei University College of Medicine

  collaborator UNKNOWN

• Gangnam Severance Hospital, Yonsei University College of Medicine

  collaborator UNKNOWN

• Asan Medical Center

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• National Cancer Center, Korea

  lead OTHER_GOV

Principal Investigators

• Il Ju Choi, MD, PhD · National Cancer Center, Korea

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-11

Primary Completion

2028-02-28

Completion

2029-02-28

Countries

• South Korea

Study Locations