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Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Digestive System Diseases Behavioral: endoscopic submucosal dissection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01378507

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Contact: Zhong-Sheng Lu, M.D. 86-10-66937467

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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jin Huang, M.D.   
Principal Investigator: Zhong-Sheng Lu, M.D.         
Sub-Investigator: Jin Huang, M.D.         
Sponsors and Collaborators
Chinese PLA General Hospital
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lu Zhong-Sheng, Department of Gastroenterology and Hepatology Identifier: NCT01378507     History of Changes
Other Study ID Numbers: 20110526004
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: May 2011

Keywords provided by Chinese PLA General Hospital:
endoscopic submucosal dissection
gastrointestinal neoplasm

Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site