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

2014-07-24 14:01:11 | BioPortfolio

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.

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 Design

Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Endoscopic Submucosal Dissection

Intervention

Endoscopic Submucosal Dissection

Location

Inje University Busan Baik Hospital and 10 other institutes
Busan
Korea, Republic of
614-735

Status

Recruiting

Source

National Evidence-Based Healthcare Collaborating Agency

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:11-0400

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