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

NCT ID: NCT01496781

Last Updated: 2012-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endoscopic Hemostasis Colonic Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EndoClot

This arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip.

Group Type EXPERIMENTAL

EndoClot

Intervention Type PROCEDURE

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Hemoclip

This arm is used as a control treatment group to compare with Endoclot treatment.

Group Type ACTIVE_COMPARATOR

Hemoclip

Intervention Type PROCEDURE

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

Interventions

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Hemoclip

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

Intervention Type PROCEDURE

EndoClot

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Intervention Type PROCEDURE

Other Intervention Names

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metallic hemoclip (Cat# HX-610-090L, Olympus) EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

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Zhiguo Liu

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Parra-Blanco A, Kaminaga N, Kojima T, Endo Y, Uragami N, Okawa N, Hattori T, Takahashi H, Fujita R. Hemoclipping for postpolypectomy and postbiopsy colonic bleeding. Gastrointest Endosc. 2000 Jan;51(1):37-41. doi: 10.1016/s0016-5107(00)70384-1.

Reference Type BACKGROUND
PMID: 10625793 (View on PubMed)

Lin LF, Siauw CP, Ho KS, Tung JC. Endoscopic hemoclip treatment of gastrointestinal bleeding. Chang Gung Med J. 2001 May;24(5):307-12.

Reference Type BACKGROUND
PMID: 11480327 (View on PubMed)

Binmoeller KF, Thonke F, Soehendra N. Endoscopic hemoclip treatment for gastrointestinal bleeding. Endoscopy. 1993 Feb;25(2):167-70. doi: 10.1055/s-2007-1010277.

Reference Type BACKGROUND
PMID: 8491134 (View on PubMed)

Katsinelos P, Paroutoglou G, Beltsis A, Papaziogas B, Gouvalas A, Chatzimavroudis G, Vlachakis I, Mimidis K, Vradelis S, Pilpilidis I. Endoscopic hemoclip application in the treatment of nonvariceal gastrointestinal bleeding: short-term and long-term benefits. Surg Laparosc Endosc Percutan Tech. 2005 Aug;15(4):187-90. doi: 10.1097/01.sle.0000174575.52840.23.

Reference Type BACKGROUND
PMID: 16082303 (View on PubMed)

Kouklakis G, Mpoumponaris A, Gatopoulou A, Efraimidou E, Manolas K, Lirantzopoulos N. Endoscopic resection of large pedunculated colonic polyps and risk of postpolypectomy bleeding with adrenaline injection versus endoloop and hemoclip: a prospective, randomized study. Surg Endosc. 2009 Dec;23(12):2732-7. doi: 10.1007/s00464-009-0478-3. Epub 2009 May 9.

Reference Type BACKGROUND
PMID: 19430833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21782216 (View on PubMed)

Other Identifiers

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20111219

Identifier Type: -

Identifier Source: org_study_id

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