Efficacy and Safety Study of Endoscopic Submucosal Dissec... | NCT01132469

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

NCT01132469

Sponsor

National Evidence-Based Healthcare Collaborating Agency

Status

Unknown status

Last Update Posted

May 28, 2010Estimated

Enrollment

1,158Estimated

Phase

Not Applicable

Conditions

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

Interventions

Endoscopic Submucosal Dissection

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2016Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

May 24, 2010

First Submission Date that Met QC Criteria

May 26, 2010

First Posted Date

May 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2010

Last Update Posted Date

May 28, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,158Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoscopic Submucosal Dissection	Experimental	Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection	Procedure: Endoscopic Submucosal Dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Submucosal Dissection	Procedure	5-years follow-up after Endoscopic Submucosal Dissection	Endoscopic Submucosal Dissection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eunhee Shin, Ph.D.	Contact	82-2-2174-2740		hshin@neca.re.kr
Jonghee Kim, MS	Contact	82-2-2174-2742		goldpaper2@neca.re.kr

Overall Officials

Name	Affiliation	Role
Sang-Yong Seol, M.D.	Inje University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University Busan Baik Hospital and 10 other institutes	Recruiting	Busan		614-735	South Korea

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures