MedDataX Logo

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

NCT ID: NCT04890171

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2029-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Cancer Undifferentiated Type Expanded Indication of Endoscopic Resection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Early gastric cancer Endoscopic submucosal dissection Surgery Undifferentiated type Expanded indication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endoscopic treatment arm

Endoscopic submucosal dissection

Group Type ACTIVE_COMPARATOR

Endoscopic submucosal dissection

Intervention Type PROCEDURE

Endoscopic submucosal dissection by a endoscopist using endoscopic devices

Surgical treatment group

Gastrectomy with lymph node dissection

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Gastrectomy with lymph node dissection by a surgeon

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic submucosal dissection

Endoscopic submucosal dissection by a endoscopist using endoscopic devices

Intervention Type PROCEDURE

Surgery

Gastrectomy with lymph node dissection by a surgeon

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul St. Mary's Hospital, The Catholic University

UNKNOWN

Sponsor Role collaborator

Chilgok Kyungpook National University Hospital

UNKNOWN

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center, Sungkyunkwan University School of Medicine

UNKNOWN

Sponsor Role collaborator

Severance Hospital, Yonsei University College of Medicine

UNKNOWN

Sponsor Role collaborator

Gangnam Severance Hospital, Yonsei University College of Medicine

UNKNOWN

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Il Ju Choi

Principal Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Il Ju Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Il Ju Choi, MD, PhD

Role: CONTACT

Phone: +82-31-920-2282

Email: [email protected]

Young-Il Kim, MD, PhD

Role: CONTACT

Phone: +82-31-920-1712

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Il Ju Choi, M.D., Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCC2021-0117

Identifier Type: -

Identifier Source: org_study_id