Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04890171
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2021-05-11
Brief Title:
Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type a Multicenter Randomized Controlled Trial ERASE-GC Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERASE-GC
Brief 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
Detailed Description:
Endoscopic submucosal dissection ESD is a minimally invasive treatment of early gastric cancer EGC Because of the stomach preservation ESD provides a better quality of life QoL in EGC patients than surgery In addition medical costs are lower in patients underwent ESD than in those underwent surgery In 2018 gastric cancer management guidelines by the Korean Gastric Cancer Association and Japanese Gastric Cancer Association JGCA stated that undifferentiated type of EGC clinically diagnosed as tumor confined to the mucosa without ulcer and size 2 cm is included in the expanded indication of ESD In the 2018 JGCA guideline version 5 ESD is an investigational treatment for patients with undifferentiated type of EGC meeting the expanded indication whereas surgery gastrectomy with lymph node dissection is a standard treatment Previous single center retrospective studies reported favorable long-term outcomes of ESD for undifferentiated type EGC meeting the expanded criteria on final pathological evaluations compared with that of surgery More recently a multi-center retrospective cohort study including 18 Korean university hospitals also reported no significant difference in overall mortality between ESD and surgery after propensity score matching hazard ratio HR for overall mortality in the ESD group 236 95 confidence interval CI 091-610 p0078 during a median follow-up of 756 months However gastric cancer recurrence occurred only in the ESD group and the HR for gastric cancer recurrence in the ESD group was 2549 95 CI 132-49127 p0032 The 3-year disease-free survival DFS rate including gastric cancer recurrence or death was 949 in the ESD group and 981 in the surgery group Thus surgery group had a better DFS than ESD group p0002 by log-rank test and the HR for gastric cancer recurrence or death in the surgery group compared with the ESD group was 026 95 CI 010-064 p0003 However previous studies could provide only a low level of evidence because of study limitations including the retrospective study design and incomplete data of patient survival and gastric cancer recurrence during follow-up The studies did not evaluate QoL and cost-effectiveness after ESD and surgery Therefore we designed a multi-center randomized controlled trial to provide a high level of evidence for clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None