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

May 26, 2010 updated by: National Evidence-Based Healthcare Collaborating Agency

Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

1158

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 Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Recruiting
        • Inje University Busan Baik Hospital and 10 other institutes
        • Contact:
        • Principal Investigator:
          • Sang-Yong Seol, 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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.

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: N/A
  • 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
Procedure: Endoscopic Submucosal Dissection
5-years follow-up after Endoscopic Submucosal Dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
5-year disease(gastric cancer)-free survival rate after ESD procedure
Time Frame: 5 years after ESD
5 years after ESD

Secondary Outcome Measures

Outcome Measure
Time Frame
Short-term result(Histological complete resection,complication)
Time Frame: within the first 7 days after ESD
within the first 7 days after ESD
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
within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
The quality of life after ESD
Time Frame: before and 7 days, 3months, 6months after ESD
before and 7 days, 3months, 6months after ESD
The costs of ESD
Time Frame: From the admission to discharge
From the admission to discharge
The safety of ESD procedure
Time Frame: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
within the 7 days, 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

National Evidence-Based Healthcare Collaborating Agency

Investigators

  • Principal Investigator: Sang-Yong Seol, M.D., Inje University College of Medicine

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

May 1, 2010

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA09-003

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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