EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

Completed

• Conditions: Colonic Polyps; Endoscopic Hemostasis
• Interventions: Device: EndoClot

• Registration Number: NCT01735786
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2012-11
• Study First Submitted: 2012-11-25
• Study First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Study First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	EndoClot	Subjects in this group will received Endoclot treatment immediately after EMR.

Primary Outcome Measures

Name	Time	Method
Rebleeding rate after EMR procedure	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.

Secondary Outcome Measures

Name	Time	Method
Mucosal healing after EMR	up to 1 month	Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
gastrointestinal tract obstruction	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.

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shanxi, China