Colonic Polyps Clinical Trial
— IvUOfficial title:
Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps
NCT number | NCT01712048 |
Other study ID # | 2012.070-2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | December 2019 |
Verified date | February 2020 |
Source | California Pacific Medical Center Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare the efficacy and safety of two standard methods of polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR) and full water emersion (without submucosal injection) EMR, for large colorectal polyps.
Status | Completed |
Enrollment | 170 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients age >18 years that are scheduled for endoscopic resection of large colo-rectal lesions who consent to this study. Exclusion Criteria: - Patients unable to provide informed consent. - Patients with lesions showing adenoma invasion into the muscularis propria on EUS. - Patients without at least one colo-rectal lesions = 20mm. |
Country | Name | City | State |
---|---|---|---|
United States | California Pacific Medical Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
California Pacific Medical Center Research Institute |
United States,
Kudo S, Kashida H, Nakajima T, Tamura S, Nakajo K. Endoscopic diagnosis and treatment of early colorectal cancer. World J Surg. 1997 Sep;21(7):694-701. Review. — View Citation
Nelson DB. Techniques for difficult polypectomy. MedGenMed. 2004 Oct 25;6(4):12. Review. — View Citation
Norton ID, Wang L, Levine SA, Burgart LJ, Hofmeister EK, Rumalla A, Gostout CJ, Petersen BT. Efficacy of colonic submucosal saline solution injection for the reduction of iatrogenic thermal injury. Gastrointest Endosc. 2002 Jul;56(1):95-9. — View Citation
ROSENBERG N. Submucosal saline wheal as safety factor in fulguration or rectal and sigmoidal polypi. AMA Arch Surg. 1955 Jan;70(1):120-2. — View Citation
Zarchy T. Risk of submucosal saline injection for colonic polypectomy. Gastrointest Endosc. 1997 Jul;46(1):89-90. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma recurrence rate | 6 months | ||
Secondary | Adverse event rate | 48 hours | ||
Secondary | Procedure time | 24 hours |
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