An interventional study of Endoscopic Submucosal Dissection in Endoscopic Submucosal Dissection, Early Gastric Cancer and Multi-center, Single-arm Clinical Trial, sponsored by National Evidence-Based Healthcare Collaborating Agency. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-05-28.
Sponsored by National Evidence-Based Healthcare Collaborating Agency · Not applicable, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 1,158 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Evidence-Based Healthcare Collaborating Agency is the lead sponsor of 2 studies on the registry; none are open to participants now.
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ESD GROUP
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection
Procedure: Endoscopic Submucosal Dissection
5-years follow-up after Endoscopic Submucosal Dissection
5-year disease(gastric cancer)-free survival rate after ESD procedure
Time frame: 5 years after ESD
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
This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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National Evidence-Based Healthcare Collaborating Agency