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

Not Applicable

• Conditions: Endoscopic Submucosal Dissection; Early Gastric Cancer; Multi-center, Single-arm Clinical Trial; Historical Control Group; Quality of Life and Cost Analysis
• Interventions: Procedure: Endoscopic Submucosal Dissection

• Registration Number: NCT01132469
• Lead Sponsor: National Evidence-Based Healthcare Collaborating Agency

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-26
• Last Update Submitted: 2010-05-26
• Study First Posted: 2010-05-28
• Last Update Posted: 2010-05-28
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Submucosal Dissection	Endoscopic Submucosal Dissection	Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection

Primary Outcome Measures

Name	Time	Method
5-year disease(gastric cancer)-free survival rate after ESD procedure	5 years after ESD

Secondary Outcome Measures

Name	Time	Method
Short-term result(Histological complete resection,complication)	within the first 7 days after ESD
The incidence of reoccurrence and Ectopic foci	within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
The quality of life after ESD	before and 7 days, 3months, 6months after ESD
The costs of ESD	From the admission to discharge
The safety of ESD procedure	within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Trial Locations

Locations (1)

Inje University Busan Baik Hospital and 10 other institutes; 🇰🇷 Busan, Korea, Republic of