Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer

National Evidence-Based Healthcare Collaborating Agency1,158 enrolled

Overview

The purpose of this study is to evaluate the safety and clinical effectiveness of ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment.

Traditionally open-gastrectomy is the standard treatment for gastric cancer without distant metastasis, but high mortality and morbidity, the intense weight loss, food intake difficulties after surgery are fraught, including problems with the drawback of significantly degrading the quality of life. Therefore, a lot of effort to seek the more simple treatment than open gastrectomy has been made, recently the endoscopic treatment for early gastric cancer is the most widely used treatment. This single-arm, multi-center study enroll early gastric cancer patients after ESD compared with the retrospective control(surgical treatment) group considering the unreality of the randomized clinical trials. In addition, the quality of life assessment by the EORTC C30/STO22 tools before and after ESD procedure in enrolled patients will be performed and the direct cost analysis also will be conducted.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,158

Conditions

Endoscopic Submucosal Dissection Early Gastric Cancer Multi-center, Single-arm Clinical Trial Historical Control Group Quality of Life and Cost Analysis

Interventions

Endoscopic Submucosal DissectionPROCEDURE

5-years follow-up after Endoscopic Submucosal Dissection

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

1. ESD GROUP Inclusion Criteria: * Korean people aged \>=20 years * Endoscopic Grossly the lesion diameter ≤ 3cm * Endoscopic biopsy results: Well-differentiated and moderately differentiated adenocarcinoma * No ulcers in lesions * Endoscopic biopsy results: In case of gastric cancer, no metastasis in CT test performed before ESD procedure Exclusion Criteria: * Subject with history of malignant disease in other organs * Subject with history of stomach surgery due to peptic ulceration etc. * As the cases of an absolute contraindication of general anesthesia; Subject with chronic liver disease over Child score B, Subject with chronic Renal Disease requiring hemodialysis or peritoneal dialysis, Subject with heart failure more than Ⅲ score according to New York Heart Association Classification, Subject with severe systemic diseases such as respiratory disease * Subject with Bleeding tendency * Pregnant woman or woman with possibility of pregnancy * Subject who cann't be obtained informed consent * Subject who is unable to follow up for any other reason 2. Surgery Group(Retrospective data collection) Inclusion Criteria: * Subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 \~2004. 12. 31 * Korean people aged \>=20 years * Early gastric cancer confirmed by pathology during gastric surgery; Gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis * No history of malignant disease in other organs * No history of stomach surgery due to peptic ulceration etc.

Locations (1)

Inje University Busan Baik Hospital and 10 other institutes

Busan, South Korea

RECRUITING

Outcomes

Primary Outcomes

5-year disease(gastric cancer)-free survival rate after ESD procedure

Time frame: 5 years after ESD

Secondary Outcomes

Short-term result(Histological complete resection,complication)

Time frame: within the first 7 days after ESD

The incidence of reoccurrence and Ectopic foci

Time frame: within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

The quality of life after ESD

Time frame: before and 7 days, 3months, 6months after ESD

The costs of ESD

Time frame: From the admission to discharge

The safety of ESD procedure

Time frame: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Central Contacts

Eunhee Shin, Ph.D.

CONTACT

82-2-2174-2740 hshin@neca.re.kr

Jonghee Kim, MS

CONTACT

82-2-2174-2742 goldpaper2@neca.re.kr

Data from ClinicalTrials.gov

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