EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection (EMR)
|ClinicalTrials.gov Identifier: NCT01496781|
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : April 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Endoscopic Hemostasis Colonic Polyps||Procedure: Hemoclip Procedure: EndoClot||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EndoClotTM Absorbable Polysaccharide Hemostat in Comparison With Metallic Hemoclip for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection: a Prospective, Randomized Trial|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
This arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip.
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
Other Name: EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)
Active Comparator: Hemoclip
This arm is used as a control treatment group to compare with Endoclot treatment.
Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.
Other Name: metallic hemoclip (Cat# HX-610-090L, Olympus)
- Hemostasis rate after EMR [ Time Frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved. ]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
- Mucosal healing after EMR [ Time Frame: up to 1 month ]Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
- Time taken to achieve hemostasis [ Time Frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved. ]The time taken to achieve hemostasis is recorded immediately after EMR procedure to reflect the technical difficulty of hemostasis measure.
- Rebleeding rate after EMR procedure [ Time Frame: up to 1 week ]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.
- gastrointestinal tract obstruction [ Time Frame: up to 1 month ]Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496781
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|