NCT01132469

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 28, 2010

Status Verified

May 1, 2010

Enrollment Period

6.6 years

First QC Date

May 24, 2010

Last Update Submit

May 26, 2010

Conditions

Endoscopic Submucosal DissectionEarly Gastric CancerMulti-center, Single-arm Clinical TrialHistorical Control GroupQuality of Life and Cost Analysis

Outcome Measures

Primary Outcomes (1)

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

    5 years after ESD

Secondary Outcomes (5)

  • Short-term result(Histological complete resection,complication)

    within the first 7 days after ESD

  • The incidence of reoccurrence and Ectopic foci

    within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

  • The quality of life after ESD

    before and 7 days, 3months, 6months after ESD

  • The costs of ESD

    From the admission to discharge

  • The safety of ESD procedure

    within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Study Arms (1)

Endoscopic Submucosal Dissection

EXPERIMENTAL

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

Procedure: Endoscopic Submucosal Dissection

Interventions

Endoscopic Submucosal DissectionPROCEDURE

5-years follow-up after Endoscopic Submucosal Dissection

Endoscopic Submucosal Dissection

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Busan Baik Hospital and 10 other institutes

Busan, 614-735, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Sang-Yong Seol, M.D.

    Inje University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunhee Shin, Ph.D.

CONTACT

82-2-2174-2740hshin@neca.re.kr

Jonghee Kim, MS

CONTACT

82-2-2174-2742goldpaper2@neca.re.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 28, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

May 28, 2010

Record last verified: 2010-05

Locations

KR(1)