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Completed

NCT Number: NCT01735786

EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

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.

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Key information

Conditions

Endoscopic Hemostasis Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EndoClot

Device

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2012
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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