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

Early Gastric Cancer Clinical Trial

— ESD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01132469
• Other study ID #: NA09-003
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2010
• Last updated: May 26, 2010
• Start date: May 2010
• Est. completion date: June 2017

Study information

• Verified date: May 2010
• Source: National Evidence-Based Healthcare Collaborating Agency
• Contact: Eunhee Shin, Ph.D.
• Phone: 82-2-2174-2740
• Email: hshin[@]neca.re.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1158
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 ? 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Gastric Cancer
• Endoscopic Submucosal Dissection
• Historical Control Group
• Multi-center, Single-arm Clinical Trial
• Quality of Life and Cost Analysis
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Baik Hospital and 10 other institutes	Busan

Sponsors (1)

Lead Sponsor	Collaborator
National Evidence-Based Healthcare Collaborating Agency

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year disease(gastric cancer)-free survival rate after ESD procedure		5 years after ESD	No
Secondary	Short-term result(Histological complete resection,complication)		within the first 7 days after ESD	Yes
Secondary	The incidence of reoccurrence and Ectopic foci		within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD	No
Secondary	The quality of life after ESD		before and 7 days, 3months, 6months after ESD	No
Secondary	The costs of ESD		From the admission to discharge	No
Secondary	The safety of ESD procedure		within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD	Yes