Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms|
- The lesion result before ESD [ Time Frame: within 7 days before ESD ] [ Designated as safety issue: Yes ]Including the location, morphology and size under endoscopy and narrow banding image of lesion.
- Short-term result after ESD [ Time Frame: whithin 7 days after ESD ] [ Designated as safety issue: Yes ]Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.
- The safety of ESD procedure [ Time Frame: 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD ] [ Designated as safety issue: Yes ]including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Endoscopic Submucosal Dissection
Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection
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.
Other Name: Endoscopic Submucosal Dissection(ESD)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378507
|Contact: Zhong-Sheng Lu, M.D.||firstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Jin Huang, M.D. email@example.com|
|Principal Investigator: Zhong-Sheng Lu, M.D.|
|Sub-Investigator: Jin Huang, M.D.|
|Study Chair:||Zhong-Sheng Lu, M.D.||Chinese PLA General Hospital|
|Study Director:||Yun-Sheng Yang, M.D.||Chinese PLA General Hospital|
|Principal Investigator:||Jin Huang, M.D.||Chinese PLA General Hospital|