Colonic Polyps, Endoscopic Hemostasis
Conditions
Keywords
Endoscopic Hemostasis, metallic hemoclip, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps
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.
Interventions
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis rate after EMR | Up to half an hour immediately after EMR procedure to ensure successful management is achieved. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal healing after EMR | up to 1 month | 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 | Up to half an hour immediately after EMR procedure to ensure successful management is achieved. | 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 | up to 1 week | 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 | up to 1 month | Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study. |
Countries
China
Outcome results
None listed