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

National Evidence-Based Healthcare Collaborating Agency

Status: Unknown

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

Treatments: Procedure: Endoscopic Submucosal Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT01132469

NA09-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,158 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,158 participants in 1 patient group

Endoscopic Submucosal Dissection

Experimental group

Description:

Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection

Treatment:

Procedure: Endoscopic Submucosal Dissection