Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Study Description

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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.

Study Design

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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

Arms and Interventions

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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)

Outcome Measures

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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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Contacts

Contact: Zhong-Sheng Lu, M.D.	86-10-66937467	lzs936150@sohu.com

Locations

China, Beijing
Chinese PLA General Hospital	Recruiting
Beijing, Beijing, China, 100853
Contact: Jin Huang, M.D. lily712@vip.sina.com
Principal Investigator: Zhong-Sheng Lu, M.D.
Sub-Investigator: Jin Huang, M.D.

Sponsors and Collaborators

Chinese PLA General Hospital

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.

Responsible Party:	Lu Zhong-Sheng, Department of Gastroenterology and Hepatology
ClinicalTrials.gov Identifier:	NCT01378507 History of Changes
Other Study ID Numbers:	20110526004
First Posted:	June 22, 2011
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:

Neoplasms; Digestive System Diseases; Gastrointestinal Diseases	Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site