EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection (EMR)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Hemostasis rate after EMR [ Time Frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.
|Study Start Date:||April 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496781
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|