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Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01378507
Collaborator
(none)
500
Enrollment
1
Location
1
Arm
51
Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: endoscopic submucosal dissection
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2009
Anticipated Primary Completion Date :
Jun 1, 2011
Anticipated Study Completion Date :
Apr 1, 2013

Arms and Interventions

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 Names:
  • Endoscopic Submucosal Dissection(ESD)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The lesion result before ESD [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing Beijing China 100853

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01378507
    Other Study ID Numbers:
    • 20110526004
    First Posted:
    Jun 22, 2011
    Last Update Posted:
    Jun 22, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    endoscopic submucosal dissection
    gastrointestinal neoplasm
    Additional relevant MeSH terms:
    Neoplasms
    Gastrointestinal Neoplasms
    Digestive System Neoplasms
    Digestive System Diseases
    Gastrointestinal Diseases

    Study Results

    No Results Posted as of Jun 22, 2011