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EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection (EMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01496781
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Endoscopic Hemostasis Colonic Polyps Procedure: Hemoclip Procedure: EndoClot

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2010
Primary Completion Date : February 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: EndoClot
This arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip.
Procedure: EndoClot
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.
Procedure: Hemoclip
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)

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • consecutive cases of colorectal polyps and submucosal tumors 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496781

China, Shaanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
More Information

Responsible Party: Zhiguo Liu, Associated Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT01496781     History of Changes
Other Study ID Numbers: 20111219
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Zhiguo Liu, Xijing Hospital of Digestive Diseases:
Endoscopic Hemostasis
metallic hemoclip
EndoClot Absorbable Polysaccharide Hemostat
Colonic Polyps

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Pathological Conditions, Anatomical