Surgicel® Fibrillar for Delayed Bleeding After ESD

NCT01758965 — Not applicable, Completed, 146 participants, Soonchunhyang University Hospital

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Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study

Registry	NCT01758965
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	146 (Actual)
Sponsor	Soonchunhyang University Hospital (Other)
Conditions	Benign Neoplasm of Stomach, Malignant Neoplasm of Stomach
Interventions	PPI, H2RA and surgicel (Other)
Dates	start 2012-12-01, primary completion 2013-12-01, completion 2013-12-01, first posted 2013-01-01, last updated 2014-05-13
Locations	1 site in South Korea

-Summary

The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors

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+Detailed description

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 : 157 4. Result

1. Primary endpoint: rate of delayed bleeding after ESD
2. Secondary endpoint: follow-up hemoglobin after ESD

+Arms and interventions

Arm	Type	Interventions	Description
combination therapy of H2RA and surgicel	Experimental	Other: H2RA and surgicel	H2RA and surgicel
Monotherapy of PPI	Experimental	Other: PPI	PPI

PPI (Other): monotherapy of PPI
H2RA and surgicel (Other): combination therapy of H2RA and surgicel

+Outcome measures

Primary outcomes

Delayed bleeding rate after ESD [1 year]

+Eligibility

Sex: All, ages: 20 Years to any

Inclusion Criteria:

* ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

* Coagulopathy: liver cirrhosis, thrombocytopenia
* Anti-platelet agents

+Locations (1)

Facility	City	Country	Status
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine	Bucheon-si, Gyeonggi-do	South Korea