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Completed

NCT Number: NCT01496781

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

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.

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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

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 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 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.

Treatment and study plan

Hemoclip

Procedure

Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.

Other names: metallic hemoclip (Cat# HX-610-090L, Olympus)

EndoClot

Procedure

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Other names: EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)

Primary outcomes

  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 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. 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study 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

Acronym: EMR

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2011
Registry last updated
Apr 17, 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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