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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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014