EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

Study Overview
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Brief Summary
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Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. 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 study has been designed to observe the effect of rebleeding prevention after EMR.

Official Title
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EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)

Conditions
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Endoscopic Hemostasis, Colonic Polyps

Intervention / Treatment
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* Device: EndoClot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: consecutive cases of colorectal polyps and submucosal lesions 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment group<br>Subjects in this group will received Endoclot treatment immediately after EMR. | Device: EndoClot<br>* EndoClot hemostat is applied immediately after EMR to achieve hemostasis.<br>|
| Control group<br>Subjects in this group will not received any hemostasis treatment after EMR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate after EMR procedure | Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin > 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope. | up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing after EMR | Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing. | up to 1 month | 
| gastrointestinal tract obstruction | Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study. | up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Hemostasis, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps