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Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

18 Years
90 Years
Open (Enrolling)
Digestive System Diseases

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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:


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:


Principal Investigator

Zhong-Sheng Lu, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Chinese PLA General Hospital


China: Ethics Committee

Study ID:




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