EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

Colonic Polyps Clinical Trial

Official title:

EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735786
• Other study ID #: 20121125
• Status: Completed
• Phase: N/A
• First received: November 25, 2012
• Last updated: November 27, 2012
• Start date: April 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Xijing Hospital of Digestive Diseases
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colonic Polyps
• Endoscopic Hemostasis

Intervention

Device:
• EndoClot
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No