Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
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|ClinicalTrials.gov Identifier: NCT01378507|
Recruitment Status : Unknown
Verified May 2011 by Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : June 22, 2011
Last Update Posted : June 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Digestive System Diseases||Behavioral: endoscopic submucosal dissection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||April 2013|
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)
- The lesion result before ESD [ Time Frame: within 7 days before ESD ]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 ]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 ]including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378507
|Contact: Zhong-Sheng Lu, M.D.||email@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Jin Huang, M.D. firstname.lastname@example.org|
|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|