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Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Primary Purpose

Digestive System Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic submucosal dissection
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digestive System Diseases focused on measuring endoscopic submucosal dissection, gastrointestinal neoplasm

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic Submucosal Dissection

Arm Description

Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection

Outcomes

Primary Outcome Measures

The lesion result before ESD
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Short-term result 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

The safety of ESD procedure
including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Full Information

First Posted
June 20, 2011
Last Updated
June 21, 2011
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01378507
Brief Title
Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
Official Title
Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Diseases
Keywords
endoscopic submucosal dissection, gastrointestinal neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Submucosal Dissection
Arm Type
Experimental
Arm Description
Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection
Intervention Type
Behavioral
Intervention Name(s)
endoscopic submucosal dissection
Other Intervention Name(s)
Endoscopic Submucosal Dissection(ESD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The lesion result before ESD
Description
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Time Frame
within 7 days before ESD
Title
Short-term result after ESD
Description
Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.
Time Frame
whithin 7 days after ESD
Secondary Outcome Measure Information:
Title
The safety of ESD procedure
Description
including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Time Frame
3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong-Sheng Lu, M.D.
Phone
86-10-66937467
Email
lzs936150@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-Sheng Lu, M.D.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yun-Sheng Yang, M.D.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jin Huang, M.D.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Huang, M.D.
Email
lily712@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Zhong-Sheng Lu, M.D.
First Name & Middle Initial & Last Name & Degree
Jin Huang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
26078575
Citation
Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
Results Reference
derived

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Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

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