Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR
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|ClinicalTrials.gov Identifier: NCT03000868|
Recruitment Status : Not yet recruiting
First Posted : December 22, 2016
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colonic Polyps||Procedure: Cold endoscopic mucosal resection Procedure: Hot endoscopic mucosal resection||Not Applicable|
Colorectal polyps are considered as precancerous lesions and endoscopical resection is currently the treatment of choice when it is possible.
Colorectal polyps are classified into diminutive polyps (<5mm in diameter), small polyps (6-9mm in diameter), and large polyps (>1cm in diameter). There are several endoscopical treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the use of electrocautery, and hot polypectomy means removal of the polyp with the use of electocautery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: Cold EMR group
Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery.
Procedure: Cold endoscopic mucosal resection
Cold endoscopic mucosal resection (EMR) means removing small colorectal polyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
Active Comparator: Hot EMR group
Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery.
Procedure: Hot endoscopic mucosal resection
Hot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
- Complete removal of the colorectal polyp [ Time Frame: At the time of the procedure (endoscopic mucosal resection) ]The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins
- Procedure time [ Time Frame: At the time of the procedure (endoscopic mucosal resection) ]The time needed for the hot EMR vs cold EMR (minutes) will be assessed.
- Complication after endoscopic mucosal resection [ Time Frame: Within 1 month ]Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000868
|Contact: Chang-hwan Park, M.D., Ph.Demail@example.com|
|Contact: Eunae Cho, M.D>||firstname.lastname@example.org|
|Korea, Republic of|
|Chonnam National University Hospital||Not yet recruiting|
|Gwangju, Korea, Republic of, 61469|
|Contact: Chang-hwan Park, M.D., Ph.D 82-62-220-6215 email@example.com|
|Contact: Eunae Cho, M.D. 82-62-220-6215 firstname.lastname@example.org|
|Study Director:||Chang-hwan Park, M.D., Ph.D||Chonnam National University Hospital|