ClinicalTrials.gov
ClinicalTrials.gov Menu

EndoClot for Preventing Rebleeding 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: NCT01735786
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Zhiguo Liu, 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.

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

Study Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)
Study Start Date : April 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Treatment group
Subjects in this group will received Endoclot treatment immediately after EMR.
Device: EndoClot
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
Control group
Subjects in this group will not received any hemostasis treatment after EMR.



Primary Outcome Measures :
  1. 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.


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. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive cases of colorectal mucosal and submucosal lesions with intented EMR treatment
Criteria

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.

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): NCT01735786


Locations
China, Shanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
Principal Investigator: Zhiguo Liu, M.D. Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032

Responsible Party: Zhiguo Liu, Associated Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT01735786     History of Changes
Other Study ID Numbers: 20121125
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

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

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