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

Colonic Polyps Clinical Trial

— EMR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496781
• Other study ID #: 20111219
• Status: Completed
• Phase: N/A
• First received: December 19, 2011
• Last updated: April 14, 2012
• Start date: April 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Xijing Hospital of Digestive Diseases
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Polyps
• Endoscopic Hemostasis

Intervention

Procedure:
• Hemoclip
Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.
• EndoClot
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

References & Publications (6)

Binmoeller KF, Thonke F, Soehendra N. Endoscopic hemoclip treatment for gastrointestinal bleeding. Endoscopy. 1993 Feb;25(2):167-70. — View Citation

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. — View Citation

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. — View Citation

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

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. — View 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® 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Mucosal healing after EMR	Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.	up to 1 month	Yes
Secondary	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.	Up to half an hour immediately after EMR procedure to ensure successful management is achieved.	No
Secondary	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.	up to 1 week	No
Secondary	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.	up to 1 month	Yes