- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253990
Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp
Comparison Between EMR and Precut-EMR for Colorectal Polyp; Randomized Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In general, a potential risk of advanced colorectal neoplasia is proportional with size. However, recent study report that occurence rate of advanced neoplasia in small polyp is 9 ~ 10 %. And, incidence of interval cancer after screening colonoscopy was reported as 10 ~ 27%. So We can suspect that complete resection of small polyp is important. Previous study recommended that endoscopic submucosal dissection (ESD) is a safe and effective procedure for treating colon polyp larger than 20 mm because of high complete resection rate and low recurrence rate. In contrast, endoscopic mucosal resection (EMR) is more recommended for resecting colon polyp smaller than 20 mm because of technical ease and low rate of complication.
However, Complete resection rate of conventional EMR is 60 ~ 70%. In case of incomplete resection, local recurrence rate is higher than complete resection. And In case of adenocarcinoma, specimen of piecemeal resection cannot be evaluated a depth of invasion and resection margin, and physician cannot decide a therapeutic plan.
In precut-EMR, mucosal resection is performed after pre-incision around a polyp. When precut EMR of polyp > 20 mm was performed in previous study, complete resection rate and en-bloc resection rate were higher and local recurrence rate was lower than conventional EMR. But, there is no study of comparsion precut EMR and conventional EMR for resecting colon polyp < 20 mm. This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR through prospective, randomized controlled trial.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Songpa-Gu
-
Seoul, Songpa-Gu, Korea, Republic of, 05505
- Asan Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients older than 20 years old who had 10~20 mm colon polyp and agreed to participate a research
Exclusion Criteria:
- Medication history of antiplatelet agent within a week of procedure.
- Medical history of coagulopathy
- More than American Society of Anesthesiology class III
- Medical history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, severe inflammatory disease.
- pedunculated polyp and polyp with malignant potential.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Precut-EMR
For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group. In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current. |
For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group. In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current. |
Active Comparator: Conventional EMR
For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group. Conventional EMR had been widely used technique. Endoscopist submucosally inject with saline around a polyp. After that, snare is positioned around a polyp, and polyp was resected using electrical current |
EMR had been widely used technique.
Endoscopist submucosally inject with saline around a polyp.
After that, snare is positioned around a polyp, and polyp was resected using electrical current.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Histologic complete resection rate
Time Frame: baseline ( enrollment of all planned patient)
|
baseline ( enrollment of all planned patient)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procedure time
Time Frame: procedure
|
procedure
|
Complication such as perforation, bleeding
Time Frame: baseline ( enrollment of all planned patient)
|
baseline ( enrollment of all planned patient)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dong-hoon Yang, Asan Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2015-1496-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonic Polyps
-
VA Greater Los Angeles Healthcare SystemTerminatedScreening of Colonic PolypsUnited States
-
Princess Alexandra Hospital, Brisbane, AustraliaRecruiting
-
Chinese University of Hong KongRecruitingColonic PolypHong Kong
-
Sengkang General HospitalMedtronicRecruiting
-
Haraldsplass Deaconess HospitalHaukeland University Hospital; Kanalspesialistene AS; European Society of Gastrointestinal...Recruiting
-
Affiliated Hospital to Academy of Military Medical...Recruiting
-
Chinese University of Hong KongCompleted
-
London North West Healthcare NHS TrustCompletedColonic PolypUnited Kingdom
-
Nuovo Regina Margherita HospitalCompleted
-
Shaare Zedek Medical CenterGoogle LLC.CompletedColonic PolypIsrael
Clinical Trials on Precut EMR
-
Prim. Prof. Dr. Oliver Findl, MBACompleted
-
Changhai HospitalUnknownBile Duct Diseases | Endoscopic Retrograde CholangiopancreatographyChina
-
Università Vita-Salute San RaffaeleValduce Hospital; Istituti Ospitalieri di Cremona; Azienda Ospedaliera Universitaria... and other collaboratorsTerminated
-
California Pacific Medical Center Research InstituteCompletedColonic Polyps | Rectal PolypsUnited States
-
Cairo UniversityUnknownCommon Bile Duct Diseases | Endoscopic Retrograde Cholangiopancreatography | Transpancreatic Precut | Precut | Double GuidewireEgypt
-
Beth Israel Deaconess Medical CenterDonald W. Reynolds FoundationCompletedElectronic Medical Record Reminders and Panel Management to Improve Primary Care of Elderly PatientsEMR Reminders to Improve Rates of Recommended CareUnited States
-
Matthias LöhrCompletedBarrett EsophagusSweden
-
Indiana UniversityJohn D. Dingell VA Medical Center; White River Junction Veterans Affairs Medical...CompletedColon Cancer | Colon Adenoma | Colon PolypUnited States
-
Samsung Medical CenterCompletedThoracic Aortic SurgeryKorea, Republic of
-
Chinese University of Hong KongTokyo University; Gifu University Graduate School of MedicineRecruitingBile Duct DiseasesHong Kong