EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)|
- 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.
- Mucosal healing after EMR [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
- gastrointestinal tract obstruction [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]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)|
Subjects in this group will received Endoclot treatment immediately after EMR.
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
Subjects in this group will not received any hemostasis treatment after EMR.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735786
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shanxi, China, 710032|
|Principal Investigator:||Zhiguo Liu, M.D.||Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032|