Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Chinese PLA General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Chinese PLA General Hospital
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01378507
First received: June 20, 2011
Last updated: June 21, 2011
Last verified: May 2011
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Purpose
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 | Intervention |
|---|---|
|
Digestive System Diseases |
Behavioral: endoscopic submucosal dissection |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Chinese PLA General Hospital:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 500 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378507
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
No publications provided
| Responsible Party: | Lu Zhong-Sheng, Department of Gastroenterology and Hepatology |
| ClinicalTrials.gov Identifier: | NCT01378507 History of Changes |
| Other Study ID Numbers: | 20110526004 |
| Study First Received: | June 20, 2011 |
| Last Updated: | June 21, 2011 |
| Health Authority: | China: Ethics Committee |
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 |
ClinicalTrials.gov processed this record on May 16, 2013