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Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer (ESD)

Primary Purpose

Endoscopic Submucosal Dissection, Early Gastric Cancer, Multi-center, Single-arm Clinical Trial

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopic Submucosal Dissection
Sponsored by
National Evidence-Based Healthcare Collaborating Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endoscopic Submucosal Dissection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  1. ESD GROUP

    Inclusion Criteria:

    • Korean people aged >=20 years
    • Endoscopic Grossly the lesion diameter ≤ 3cm
    • Endoscopic biopsy results: Well-differentiated and moderately differentiated adenocarcinoma
    • No ulcers in lesions
    • Endoscopic biopsy results: In case of gastric cancer, no metastasis in CT test performed before ESD procedure

    Exclusion Criteria:

    • Subject with history of malignant disease in other organs
    • Subject with history of stomach surgery due to peptic ulceration etc.
    • As the cases of an absolute contraindication of general anesthesia; Subject with chronic liver disease over Child score B, Subject with chronic Renal Disease requiring hemodialysis or peritoneal dialysis, Subject with heart failure more than Ⅲ score according to New York Heart Association Classification, Subject with severe systemic diseases such as respiratory disease
    • Subject with Bleeding tendency
    • Pregnant woman or woman with possibility of pregnancy
    • Subject who cann't be obtained informed consent
    • Subject who is unable to follow up for any other reason
  2. Surgery Group(Retrospective data collection)

Inclusion Criteria:

  • Subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 ~2004. 12. 31
  • Korean people aged >=20 years
  • Early gastric cancer confirmed by pathology during gastric surgery; Gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis
  • No history of malignant disease in other organs
  • No history of stomach surgery due to peptic ulceration etc.

Sites / Locations

  • Inje University Busan Baik Hospital and 10 other institutesRecruiting

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

5-year disease(gastric cancer)-free survival rate after ESD procedure

Secondary Outcome Measures

Short-term result(Histological complete resection,complication)
The incidence of reoccurrence and Ectopic foci
The quality of life after ESD
The costs of ESD
The safety of ESD procedure

Full Information

First Posted
May 24, 2010
Last Updated
May 26, 2010
Sponsor
National Evidence-Based Healthcare Collaborating Agency
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1. Study Identification

Unique Protocol Identification Number
NCT01132469
Brief Title
Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer
Acronym
ESD
Official Title
Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Evidence-Based Healthcare Collaborating Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and clinical effectiveness of ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment.
Detailed Description
Traditionally open-gastrectomy is the standard treatment for gastric cancer without distant metastasis, but high mortality and morbidity, the intense weight loss, food intake difficulties after surgery are fraught, including problems with the drawback of significantly degrading the quality of life. Therefore, a lot of effort to seek the more simple treatment than open gastrectomy has been made, recently the endoscopic treatment for early gastric cancer is the most widely used treatment. This single-arm, multi-center study enroll early gastric cancer patients after ESD compared with the retrospective control(surgical treatment) group considering the unreality of the randomized clinical trials. In addition, the quality of life assessment by the EORTC C30/STO22 tools before and after ESD procedure in enrolled patients will be performed and the direct cost analysis also will be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Submucosal Dissection, Early Gastric Cancer, Multi-center, Single-arm Clinical Trial, Historical Control Group, Quality of Life and Cost Analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1158 (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
Procedure
Intervention Name(s)
Endoscopic Submucosal Dissection
Intervention Description
5-years follow-up after Endoscopic Submucosal Dissection
Primary Outcome Measure Information:
Title
5-year disease(gastric cancer)-free survival rate after ESD procedure
Time Frame
5 years after ESD
Secondary Outcome Measure Information:
Title
Short-term result(Histological complete resection,complication)
Time Frame
within the first 7 days after ESD
Title
The incidence of reoccurrence and Ectopic foci
Time Frame
within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Title
The quality of life after ESD
Time Frame
before and 7 days, 3months, 6months after ESD
Title
The costs of ESD
Time Frame
From the admission to discharge
Title
The safety of ESD procedure
Time Frame
within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
ESD GROUP Inclusion Criteria: Korean people aged >=20 years Endoscopic Grossly the lesion diameter ≤ 3cm Endoscopic biopsy results: Well-differentiated and moderately differentiated adenocarcinoma No ulcers in lesions Endoscopic biopsy results: In case of gastric cancer, no metastasis in CT test performed before ESD procedure Exclusion Criteria: Subject with history of malignant disease in other organs Subject with history of stomach surgery due to peptic ulceration etc. As the cases of an absolute contraindication of general anesthesia; Subject with chronic liver disease over Child score B, Subject with chronic Renal Disease requiring hemodialysis or peritoneal dialysis, Subject with heart failure more than Ⅲ score according to New York Heart Association Classification, Subject with severe systemic diseases such as respiratory disease Subject with Bleeding tendency Pregnant woman or woman with possibility of pregnancy Subject who cann't be obtained informed consent Subject who is unable to follow up for any other reason Surgery Group(Retrospective data collection) Inclusion Criteria: Subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 ~2004. 12. 31 Korean people aged >=20 years Early gastric cancer confirmed by pathology during gastric surgery; Gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis No history of malignant disease in other organs No history of stomach surgery due to peptic ulceration etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eunhee Shin, Ph.D.
Phone
82-2-2174-2740
Email
hshin@neca.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jonghee Kim, MS
Phone
82-2-2174-2742
Email
goldpaper2@neca.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Yong Seol, M.D.
Organizational Affiliation
Inje University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busan Baik Hospital and 10 other institutes
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Yong Seol, M.D.
Phone
82-51-890-6158
Email
seolsymd@hanmail.net
First Name & Middle Initial & Last Name & Degree
Sang-Yong Seol, M.D.

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer

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