Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Not Applicable

• Conditions: Digestive System Diseases
• Interventions: Behavioral: endoscopic submucosal dissection

• Registration Number: NCT01378507
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2011-05
• Primary Completion: 2011-06
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-21
• Last Update Submitted: 2011-06-21
• Study First Posted: 2011-06-22
• Last Update Posted: 2011-06-22
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Submucosal Dissection	endoscopic submucosal dissection	Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection

Primary Outcome Measures

Name	Time	Method
The lesion result before ESD	within 7 days before ESD	Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Short-term result after ESD	whithin 7 days after ESD	Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.

Secondary Outcome Measures

Name	Time	Method
The safety of ESD procedure	3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD	including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China