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

This study is currently recruiting participants.
Verified May 2010 by National Evidence-Based Healthcare Collaborating Agency
Sponsor:
Information provided by:
National Evidence-Based Healthcare Collaborating Agency
ClinicalTrials.gov Identifier:
NCT01132469
First received: May 24, 2010
Last updated: May 26, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Endoscopic Submucosal Dissection
Early Gastric Cancer
Multi-center, Single-arm Clinical Trial
Historical Control Group
Quality of Life and Cost Analysis
 Procedure: Endoscopic Submucosal Dissection

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Evidence-Based Healthcare Collaborating Agency:

Primary Outcome Measures:
  • 5-year disease(gastric cancer)-free survival rate after ESD procedure [ Time Frame: 5 years after ESD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short-term result(Histological complete resection,complication) [ Time Frame: within the first 7 days after ESD ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • The quality of life after ESD [ Time Frame: before and 7 days, 3months, 6months after ESD ] [ Designated as safety issue: No ]
  • The costs of ESD [ Time Frame: From the admission to discharge ] [ Designated as safety issue: No ]
  • The safety of ESD procedure [ Time Frame: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1158
Study Start Date: May 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132469

Contacts
Contact: Eunhee Shin, Ph.D. 82-2-2174-2740 hshin@neca.re.kr
Contact: Jonghee Kim, MS 82-2-2174-2742 goldpaper2@neca.re.kr

Locations
Korea, Republic of
Inje University Busan Baik Hospital and 10 other institutes Recruiting
Busan, Korea, Republic of, 614-735
Contact: Sang-Yong Seol, M.D.     82-51-890-6158     seolsymd@hanmail.net    
Principal Investigator: Sang-Yong Seol, M.D.            
Sponsors and Collaborators
National Evidence-Based Healthcare Collaborating Agency
Investigators
Principal Investigator: Sang-Yong Seol, M.D. Inje University College of Medicine
  More Information

No publications provided

Responsible Party: Eunhee Shin/General Manager of Pragmatic Clinical Trials Team, National Evidence-based Healthcare Collaborating Agency
ClinicalTrials.gov Identifier: NCT01132469     History of Changes
Other Study ID Numbers: NA09-003
Study First Received: May 24, 2010
Last Updated: May 26, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 17, 2013