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

NCT01496781 | Completed DMC

• 1 other identifier: 20111219
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Hemostasis; Colonic Polyps

Keywords

Endoscopic Hemostasis; metallic hemoclip; EndoClot Absorbable Polysaccharide Hemostat; Colonic Polyps

Outcome Measures

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

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

Secondary Outcomes (4)

• Mucosal healing after EMR

  up to 1 month

• Time taken to achieve hemostasis

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

• Rebleeding rate after EMR procedure

  up to 1 week

• gastrointestinal tract obstruction

  up to 1 month

Study Arms (2)

EndoClot

EXPERIMENTAL

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

Procedure: EndoClot

Hemoclip

ACTIVE COMPARATOR

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

Procedure: Hemoclip

Interventions

Hemoclip PROCEDURE

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)

Hemoclip

EndoClot PROCEDURE

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

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

EndoClot

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (6)

• 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.

  PMID: 10625793 BACKGROUND

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

  PMID: 11480327 BACKGROUND

• 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.

  PMID: 8491134 BACKGROUND

• 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.

  PMID: 16082303 BACKGROUND

• 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.

  PMID: 19430833 BACKGROUND

• 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.

  PMID: 21782216 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 21, 2011
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

CN (1)