Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Digestive System Diseases

Treatments: Behavioral: endoscopic submucosal dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT01378507

20110526004

Details and patient eligibility

About

Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Endoscopic Submucosal Dissection

Experimental group

Description:

Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection

Treatment:

Behavioral: endoscopic submucosal dissection