Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
18 Years
90 Years
Both
Digestive System Diseases
Trial Information
Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for
GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter
must be removed in pieces, which may result in a high recurrence rate of residual tumor
tissue. In addition, in most patients, pathological assessment cannot be conducted after the
procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform
ESD for GI neoplasms because of the high rate of complications.
Inclusion Criteria:
- Submucosal tumor
- Mucosal tumor (T1) in patients unsuitable for surgery
Exclusion Criteria:
- Endoscopic ultrasound (EUS) or CT signs of metastasis
- Insufficient access to tumor
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The lesion result before ESD
Outcome Description:
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Outcome Time Frame:
within 7 days before ESD
Safety Issue:
Yes
Principal Investigator
Zhong-Sheng Lu, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Chinese PLA General Hospital
Authority:
China: Ethics Committee
Study ID:
20110526004
NCT ID:
NCT01378507
Start Date:
January 2009
Completion Date:
April 2013
Related Keywords:
- Digestive System Diseases
- endoscopic submucosal dissection
- gastrointestinal neoplasm
- Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
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