Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps

Polyp of Large Intestine Clinical Trial

— HSPvsHSPASI  

Official title:

Hot Snare Polypectomy Vs. Hot Snare Polypectomy After Saline Injection for the Complete Resection of Neoplastic Colorectal Polyps: Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239536
• Other study ID #: XC14TIMI0039K
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: February 2018

Study information

• Verified date: April 2020
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients over the age of 30

• 5~10mm sized colorectal polyps

• Informed consent

Exclusion Criteria:

• Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)

• Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy

• ASA class III or more

• Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Related Conditions & MeSH terms

• Polyp of Large Intestine
• Polyps

Intervention

Procedure:
• hot snare polypectomy
hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
• hot snare polypectomy after saline injection
hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps

Locations

Country	Name	City	State
Korea, Republic of	Division of Gastroenterology; Seoul St. Mary's hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Bo-In Lee	Incheon St.Mary's Hospital, St. Vincent's Hospital-Manhattan

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Dwyer JP, Tan JYC, Urquhart P, Secomb R, Bunn C, Reynolds J, La Nauze R, Kemp W, Roberts S, Brown G. A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps. Endosc Int Open. 2017 Nov;5(11):E1062-E1068. doi: 10.1055/s-0043-113564. Epub 2017 Oct 27. — View Citation

Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28. — View Citation

Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Resection Rate	Complete resection was defined as the absence of residual polyp in the resection margin	2 weeks after
Secondary	Lateral Margin	Observation of maring on a recsected specimen	2 weeks after