Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Endoscopic Submucosal Dissection
    • Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Lu Zhong-Sheng, Department of Gastroenterology and Hepatology
  • Overall Official(s)
    • Zhong-Sheng Lu, M.D., Study Chair, Chinese PLA General Hospital
    • Yun-Sheng Yang, M.D., Study Director, Chinese PLA General Hospital
    • Jin Huang, M.D., Principal Investigator, Chinese PLA General Hospital
  • Overall Contact(s)
    • Zhong-Sheng Lu, M.D., 86-10-66937467, lzs936150@sohu.com

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