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

Xijing Hospital of Digestive Diseases164 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Endoscopic Hemostasis Colonic Polyps

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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.

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

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.