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EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhiguo Liu, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier:
NCT01735786
First received: November 25, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Endoscopic Hemostasis
Colonic Polyps
 Device: EndoClot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital of Digestive Diseases:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 164
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Zhiguo Liu, Associated Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT01735786     History of Changes
Other Study ID Numbers: 20121125
Study First Received: November 25, 2012
Last Updated: November 27, 2012
Health Authority: China:Xijing Hospital of Digestive Diseases

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

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
Hemostatics
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013