Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Digestive System Diseases Clinical Trial

Official title:

Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01378507
• Other study ID #: 20110526004
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2011
• Last updated: June 21, 2011
• Start date: January 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2011
• Source: Chinese PLA General Hospital
• Contact: Zhong-Sheng Lu, M.D.
• Phone: 86-10-66937467
• Email: lzs936150[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Behavioral:
• endoscopic submucosal dissection
ESD was carried out by using a single-channel upper gastrointestinal endoscope with a water-jet system (Q260J; Olympus Optical Co, Tokyo, Japan) and a high-frequency generator with an automatically controlled system (ENDOCUT mode) (Erbotom ICC 200; ERBE Elektromedizin GmbH, Tübingen, Germany). The transparent attachment was fitted on the tip of the endoscope mainly to obtain a constant endoscopic view and to create tension on the connective tissue for the submucosal dissection.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The lesion result before ESD	Including the location, morphology and size under endoscopy and narrow banding image of lesion.	within 7 days before ESD	Yes
Primary	Short-term result 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.	whithin 7 days after ESD	Yes
Secondary	The safety of ESD procedure	including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD	3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD	Yes