A Comparison of the Resection Rate for Cold and Hot Snare Polypectomy for 5-15 mm Colorectal Polyps
7th Medical Center of PLA General Hospital
1 other identifier
interventional
750
1 country
1
Brief Summary
In 2015, there were approximately 1.7 million new cases of colorectal cancer（CRC）, and the deaths was close to 832,000. CRC has become the third most common malignant tumor in the world and the second leading cause of cancer death. This is mainly because adenomatous polyps can be transformed into cancer through adenoma-cancer sequences. Screening for CRC has been shown to prevent CRC and related deaths, especially colonoscopy and endoscopic resection of adenomatous polyps. Currently, the main methods of resection for polyps below 20 mm include hot snare polypectomy (HSP) and cold snare polypectomy (CSP). Due to the use of electrocautery, HSP has been shown to cause damage to the deep submucosa, the muscularis propria and submucosal arteries, resulting in postoperative bleeding, perforation and other adverse events. Compared with HSP, the mechanical cutting method is called CSP without electrocautery. Due to the short operation time and low incidence of adverse events, especially after polypectomy, it has caused more and more attention of endoscopists. The removal of 5 mm polyps from CSP has been recommended as the preferred technique by the European Society of Gastrointestinal Endoscopy(ESGE) Guidelines. A recent multicenter, prospective study in Japan recommended CSP as the standard treatment for excision of 4-9mm polyps. However, the average diameter of polyps in this study was 5.4 mm, which was not sufficient for the safety of CSP in polyps above 5 mm. In addition, there are few prospective studies of CSP complete removal of colorectal polyps 10-15 mm. More importantly, the report pointed out that 10% of 5 to 20 mm polyps were not completely removed, and some studies have shown that the cut polyp specimens are not sufficient for adequate pathological evaluation, which the researchers do not fully recognize. In this study, the investigators were interested in comparing the complete resection rates of large (10 -15 mm) and small (4-9 mm) colorectal polyps with CSP and HSP and improved methods for evaluating complete resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2018
CompletedFirst Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedAugust 17, 2021
February 1, 2021
4.2 years
July 29, 2019
August 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete resection rate
The primary endpoint was the complete resection rate, defined as no evidence of adenomatous tissue in the biopsied specimens, among all pathologically confirmed adenomatous polyps. The complete resection rates in the HSP and CSP groups of 5-15mm polyps were compared. The complete resection rates in the HSP and CSP groups of 5-9 mm polyps group were compared. and the complete resection rates in the HSP and CSP groups of 10-15 mm polyps group were also compared.
six months
Secondary Outcomes (6)
Methodological evaluation of Endoscopic margin observation method
six months
Polyp retrieval rate
six months
Number of additional resections (snaring and/or biopsy)
six months
Rate of difficult/impossible resection by CSP
six months
Time required for resection
six months
- +1 more secondary outcomes
Study Arms (2)
Hot snare polypectomy (HSP)
ACTIVE COMPARATORThe polyp size was measured using the tip of the snare catheter (2.5 mm). According to the randomized group, patients with HSP group were treated with HSP to excise 5-15 mm colorectal polyps. After resection, the jet stream will be used to thoroughly clean the mucosal defect. After the endoscopist carefully observed the edge of the resection to complete the polypectomy, a 2- or 4-quad biopsy was performed from the symmetrical margin of the mucosal defect to confirm the presence or absence of residual lesions.
Cold snare polypectomy (CSP)
EXPERIMENTALThe polyp size was measured using the tip of the snare catheter (2.5 mm). After randomization, patients in the CSP group will be treated with CSP to remove colorectal polyps of 10-15 mm size. After resection, the jet stream will be used to thoroughly clean the mucosal defect. After the endoscopic surgeon carefully observed the resection margin to complete the polypectomy, a 2- or 4-quad biopsy was performed from the symmetrical margin of the mucosal defect to confirm the presence or absence of residual lesions.
Interventions
CSP, which does not include electrocautery to do a polypectomy with a snare.
HSP, which uses the electrocautery to do a polypectomy with a snare.
Endoscopic margin observation method, After rinsing the polyp specimen with physiological saline, fully natural extension, fixing it to the foam board with a needle, and observing the margin with a colonoscope or a magnifying colonoscope near-focus mode to determine whether there is residual polyp tissue.
Eligibility Criteria
You may qualify if:
- Patient ≥40 and \<70 years old
- Provide written informed consent
- Patients are found to have colorectal polyps between 5 and 15mm in size
You may not qualify if:
- History of inflammatory bowel disease
- Polyposis of the alimentary tract
- Antiplatelet or anticoagulant therapy 5 days before the procedure
- Pregnancy
- Haemodialysis
- An American Society of Anaesthesiologists class III or higher
- Depressed lesions and lesions highly suspected to be cancerous based on endoscopic appearance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuqi Helead
Study Sites (1)
Department of Gastroenterology, 7th medical center of PLA general hospital
Beijing, Dongcheng District, 100700, China
Related Publications (2)
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.
PMID: 28970290RESULTMatsuura N, Takeuchi Y, Yamashina T, Ito T, Aoi K, Nagai K, Kanesaka T, Matsui F, Fujii M, Akasaka T, Hanaoka N, Higashino K, Tomita Y, Ito Y, Ishihara R, Iishi H, Uedo N. Incomplete resection rate of cold snare polypectomy: a prospective single-arm observational study. Endoscopy. 2017 Mar;49(3):251-257. doi: 10.1055/s-0043-100215. Epub 2017 Feb 13.
PMID: 28192823RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
tianyang zhang
Medical department
Central Study Contacts
tianyang zhang
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- RCT-HSP-CSP
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
July 29, 2019
First Posted
August 19, 2019
Study Start
August 20, 2018
Primary Completion
October 20, 2022
Study Completion
October 20, 2022
Last Updated
August 17, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share