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

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. 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.

Official Title
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EndoClotTM Absorbable Polysaccharide Hemostat in Comparison With Metallic Hemoclip for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection: a Prospective, Randomized Trial

Conditions
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Endoscopic Hemostasis, Colonic Polyps

Intervention / Treatment
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* Procedure: Hemoclip
* Procedure: EndoClot


Participation Criteria
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Eligibility Criteria
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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.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoClot<br>This arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip. | Procedure: EndoClot<br>* EndoClot hemostat is applied immediately after EMR to achieve hemostasis.<br>* Other names: EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc);|
| Active Comparator: Hemoclip<br>This arm is used as a control treatment group to compare with Endoclot treatment. | Procedure: Hemoclip<br>* Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.<br>* Other names: metallic hemoclip (Cat# HX-610-090L, Olympus);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis rate after EMR | Initial hemostatsis was observed endoscopically immediately after application of hemoclip or Endoclot. Complete hemostatsis is ensured. Endoscopic combined hemostasis or emergency surgery would be applied if severe bleeding occurred and endoscopic management fails | Up to half an hour immediately after EMR procedure to ensure successful management is achieved. | 

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 | 
| Time taken to achieve hemostasis | The time taken to achieve hemostasis is recorded immediately after EMR procedure to reflect the technical difficulty of hemostasis measure. | Up to half an hour immediately after EMR procedure to ensure successful management is achieved. | 
| 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 | 
| 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, metallic hemoclip, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps