EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection (EMR)

Xijing Hospital of Digestive Diseases

Status

Completed

Conditions

Colonic Polyps

Endoscopic Hemostasis

Treatments

Procedure: Hemoclip

Procedure: EndoClot

Study type

Interventional

Funder types

Other

Identifiers

NCT01496781

20111219

Details and patient eligibility

About

Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This randomized controlled study has been designed to compare PAPH with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after EMR.

Enrollment

164 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

consecutive cases of colorectal polyps and submucosal tumors with anticipated complete removal endoscopically by EMR.

Exclusion criteria

severe cardiovascular diseases, liver and kidney dysfunction;
platelet and coagulation dysfunction (PLT < 50*109/L, INR > 2);
cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
cases unavailable for follow-up.