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Phase 4
20 Years
75 Years
Open (Enrolling)
Both
Gastric Epithelial Tumors

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Trial Information


1. Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer

- Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia

- Anti-platelet agents

2. Method

(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group:
monotherapy with PPI 3. Sample size : 172 4. Result

1. Primary endpoint: rate of delayed bleeding after ESD

2. Secondary endpoint: follow-up hemoglobin after ESD


Inclusion Criteria:



- ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

- Coagulopathy: liver cirrhosis, thrombocytopenia

- Anti-platelet agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Delayed bleeding rate after ESD

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MD_SCHBC_IRB_2012-06

NCT ID:

NCT01758965

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Gastric Epithelial Tumors
  • Neoplasms, Glandular and Epithelial

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