Expanded Indication of Endoscopic Resection, Stomach Cancer, Undifferentiated Type
Conditions
Keywords
Early gastric cancer, Endoscopic submucosal dissection, Surgery, Undifferentiated type, Expanded indication
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, 2.36; 95% confidence interval \[CI\] 0.91-6.10; p=0.078) during a median follow-up of 75.6 months. However, gastric cancer recurrence occurred only in the ESD group, and the HR for gastric cancer recurrence in the ESD group was 25.49 (95% CI 1.32-491.27; p=0.032). The 3-year disease-free survival (DFS) rate including gastric cancer recurrence or death was 94.9% in the ESD group and 98.1% in the surgery group. Thus, surgery group had a better DFS than ESD group (p=0.002 by log-rank test), and the HR for gastric cancer recurrence or death in the surgery group compared with the ESD group was 0.26 (95% CI, 0.10-0.64; p=0.003). 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.
Interventions
PROCEDUREEndoscopic submucosal dissection
Endoscopic submucosal dissection by a endoscopist using endoscopic devices
PROCEDURESurgery
Gastrectomy with lymph node dissection by a surgeon
Sponsors
Seoul St. Mary's Hospital, The Catholic University
Chilgok Kyungpook National University Hospital
Pusan National University Hospital
Samsung Medical Center, Sungkyunkwan University School of Medicine
Severance Hospital, Yonsei University College of Medicine
Gangnam Severance Hospital, Yonsei University College of Medicine
Asan Medical Center
Chonnam National University Hospital
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are diagnosed with undifferentiated type EGC (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) that meets the expanded indication of ESD 1) Tumor confined to the mucosa without ulcer, and size ≤2 cm on endoscopic evaluations 2) No evidence of lymph node metastasis and distant metastasis on abdominal CT scan 2. Adult patients aged 19-75 years 3. Patients who had willingness to sign an informed consent form
Exclusion criteria
1. Patient age: \< 19 years or age \> 75 years 2. Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years 3. Previous gastrectomy or esophagectomy history 4. Multiple gastric cancers 5. Current treatment for serious medical condition which could hinder study participation including severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection 6. Inability to provide an informed consent 7. Inadequate conditions for study enrollment according to the evaluation of study physicians
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival in the ITT population | 3 years after the last participant enrollment | Disease-free survival (gastric cancer recurrence or death from any causes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years after the last participant enrollment | Overall survival (death from any causes) |
| Curative resection rate of ESD | 2 year after the participant enrollment | Curative resection on the final pathological evaluation |
| 3-year disease-free survival in the PP population | 3 years after the last participant enrollment | Disease-free survival (gastric cancer recurrence or death from any causes) |
| Treatment related complications (adverse events) | 3 years after the last participant enrollment | Early (within 30 postoperative days) and late complications (after 30 postoperative days) |
| Cost-effectiveness measured with Incremental cost effective ratio (ICER) | 3 years after the last participant enrollment | — |
| Quality of life changes during follow-up periods | 3 years after the last participant enrollment | QoL changes using questionnaire |
Countries
South Korea
Contacts
Primary ContactIl Ju Choi, MD, PhD
Backup ContactYoung-Il Kim, MD, PhD
Outcome results
None listed