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

• Mucosal healing after EMR [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
  Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
• Time taken to achieve hemostasis [ Time Frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved. ] [ Designated as safety issue: No ]
  The time taken to achieve hemostasis is recorded immediately after EMR procedure to reflect the technical difficulty of hemostasis measure.
• Rebleeding rate after EMR procedure [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
  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.
• gastrointestinal tract obstruction [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
  Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.

• Mucosal healing after EMR [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
  Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Perclot will delay the musosal healing.
• Time taken to achieve hemostasis [ Time Frame: immediately after EMR procedure ] [ Designated as safety issue: No ]
  The time taken to achieve hemostasis is recorded immediately after EMR procedure to reflect the technical difficulty of hemostasis measure.
• Rebleeding rate after EMR procedure [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
  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.
• gastrointestinal tract obstruction [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
  Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.

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.

• Endoscopic Hemostasis
• Colonic Polyps

• Procedure: Hemoclip
  Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.
  Other Name: metallic hemoclip (Cat# HX-610-090L, Olympus)
• Procedure: EndoClot
  EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
  Other Name: EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)

• Experimental: EndoClot
  This arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip.
  Intervention: Procedure: EndoClot
• Active Comparator: Hemoclip
  This arm is used as a control treatment group to compare with Endoclot treatment.
  Intervention: Procedure: Hemoclip

• 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.
• Lin LF, Siauw CP, Ho KS, Tung JC. Endoscopic hemoclip treatment of gastrointestinal bleeding. Chang Gung Med J. 2001 May;24(5):307-12.
• Binmoeller KF, Thonke F, Soehendra N. Endoscopic hemoclip treatment for gastrointestinal bleeding. Endoscopy. 1993 Feb;25(2):167-70.
• 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.
• 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 May 9; [Epub ahead of print]
• 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. 2011 Jul 20; [Epub ahead of print]

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.