Clinical trial NCT01132469: Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer
Official title: Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Submucosal Dissection
Early Gastric Cancer
Multi-center, Single-arm Clinical Trial
Historical Control Group
Quality of Life and Cost Analysis
Lead sponsor: National Evidence-Based Healthcare Collaborating Agency
Sponsor class: OTHER_GOV
First posted: 2010-05-28
Enrollment: 1158
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 5-year disease(gastric cancer)-free survival rate after ESD procedure
timeFrame: 5 years after ESD
Secondary outcomes:
measure: Short-term result(Histological complete resection,complication)
timeFrame: within the first 7 days after ESD
measure: The incidence of reoccurrence and Ectopic foci
timeFrame: within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
measure: The quality of life after ESD
timeFrame: before and 7 days, 3months, 6months after ESD
measure: The costs of ESD
timeFrame: From the admission to discharge
measure: The safety of ESD procedure
timeFrame: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Baik Hospital and 10 other institutes
Study officials:
affiliation: Inje University College of Medicine
name: Sang-Yong Seol, M.D.
role: PRINCIPAL_INVESTIGATOR
References: