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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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PubMed Articles [1601 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

A method for removing lesions from gastrointestinal MUCOUS MEMBRANES. The mucosal tissue with the lesion is elevated by injecting a solution into the submucosal layer underneath it. The elevated tissue with the lesion is then cut out.

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Incision of Oddi's sphincter or Vater's ampulla performed by inserting a sphincterotome through an endoscope (DUODENOSCOPE) often following retrograde cholangiography (CHOLANGIOPANCREATOGRAPHY, ENDOSCOPIC RETROGRADE). Endoscopic treatment by sphincterotomy is the preferred method of treatment for patients with retained or recurrent bile duct stones post-cholecystectomy, and for poor-surgical-risk patients that have the gallbladder still present.

A specialized form of transanal endoscopic surgery for microscopically controlled operations in the RECTUM.

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