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CompletedNCT01496781EMRUpdated Apr 17, 2012

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

An interventional study of Hemoclip and EndoClot in Endoscopic Hemostasis and Colonic Polyps, sponsored by Xijing Hospital of Digestive Diseases. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-17.

Sponsored by Xijing Hospital of Digestive Diseases · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Endoscopic Hemostasis
  • Colonic Polyps

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Keywords

  • Endoscopic Hemostasis
  • metallic hemoclip
  • EndoClot Absorbable Polysaccharide Hemostat
  • Colonic Polyps
03

In context

Colonic Polyps

318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.

This study's enrollment of 164 is below the median of 270 across 215 interventional studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

Xijing Hospital of Digestive Diseases is the lead sponsor of 80 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • consecutive cases of colorectal polyps and submucosal tumors with anticipated complete removal endoscopically by EMR.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    EndoClot

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

    Procedure: EndoClot

  • Active comparator
    Hemoclip

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

    Procedure: Hemoclip

Interventions

  • ProcedureHemoclip

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

    Also known as: metallic hemoclip (Cat# HX-610-090L, Olympus)

  • ProcedureEndoClot

    EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

    Also known as: EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)

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What researchers measure

Primary outcomes

  1. Hemostasis rate after EMR

    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

    Time frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.

Secondary outcomes

  1. Mucosal healing after EMR

    Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.

    Time frame: up to 1 month

  2. Time taken to achieve hemostasis

    The time taken to achieve hemostasis is recorded immediately after EMR procedure to reflect the technical difficulty of hemostasis measure.

    Time frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.

  3. Rebleeding rate after EMR procedure

    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.

    Time frame: up to 1 week

  4. gastrointestinal tract obstruction

    Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.

    Time frame: up to 1 month

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Study locations

1 site
  • Xijing Hospital of Digestive Diseases
    Xi'an, Shaanxi 710032, China
08

References and documents

Publications

  • 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. PubMed 10625793 ↗
  • Lin LF, Siauw CP, Ho KS, Tung JC. Endoscopic hemoclip treatment of gastrointestinal bleeding. Chang Gung Med J. 2001 May;24(5):307-12. PubMed 11480327 ↗
  • 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. PubMed 8491134 ↗
  • 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. PubMed 16082303 ↗
  • 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. PubMed 19430833 ↗
  • 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. PubMed 21782216 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01496781
Lead sponsor
Xijing Hospital of Digestive Diseases
Responsible party
Zhiguo Liu (Associated Professor, Xijing Hospital of Digestive Diseases) — Principal investigator
First posted
Dec 21, 2011
Start date
Apr 2010
Primary completion
Feb 2012
Completion
Mar 2012
Last update
Apr 17, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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