Clinical trial NCT01496781: EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Hemostasis
Colonic Polyps
Keywords: Endoscopic Hemostasis
metallic hemoclip
EndoClot Absorbable Polysaccharide Hemostat
Colonic Polyps
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hemostasis rate after EMR
timeFrame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.
Secondary outcomes:
measure: Mucosal healing after EMR
timeFrame: up to 1 month
measure: Time taken to achieve hemostasis
timeFrame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.
measure: Rebleeding rate after EMR procedure
timeFrame: up to 1 week
measure: gastrointestinal tract obstruction
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
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citation: Wang Y, Xu M, Dong H, Liu Y, Zhao P, Niu W, Xu D, Ji X, Xing C, Lu D, Li Z. Effects of PerClot(R) on the healing of full-thickness skin wounds in rats. Acta Histochem. 2012 Jul;114(4):311-7. doi: 10.1016/j.acthis.2011.06.012. Epub 2011 Jul 22.