Clinical Trials Directory

Trials / Unknown

UnknownNCT01132469

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

Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
1,158 (estimated)
Sponsor
National Evidence-Based Healthcare Collaborating Agency · Other Government
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic Submucosal Dissection5-years follow-up after Endoscopic Submucosal Dissection

Timeline

Start date
2010-05-01
Primary completion
2016-12-01
Completion
2017-06-01
First posted
2010-05-28
Last updated
2010-05-28

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01132469. Inclusion in this directory is not an endorsement.