Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

June 21, 2011 updated by: Chinese PLA General Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Zhong-Sheng Lu, M.D.
        • Sub-Investigator:
          • Jin Huang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 7 days before ESD
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.
whithin 7 days after ESD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110526004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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