Adenomatous PolypsCSPNCT03647176
A Comparison of the Resection Rate of Cold Snare Polypectomy for Large (10-15 mm) and Small (5-9 mm) Colorectal Polyps
A study testing Cold snare polypectomy in people with Adenomatous Polyps, run by Yuqi He at 1 site in China.
Trial summary
Colorectal cancer remains the third most common cause of death from cancer worldwide. Colonoscopy allows removal of adenomatous polyps is the best colorectal cancer screening, according to the adenoma-carcinoma sequence. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- Cold snare polypectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient ≥40 and <85
- Provide written informed consent
- Patients are found to have colorectal polyps between 5 and 15mm in size
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, PLA Army General Hospital
Beijing, Dongcheng District, 100700
About this study
Official title: PLA Army General Hospital of Beijing
Colorectal cancer remains the third most common cause of death from cancer worldwide. Colonoscopy allows removal of adenomatous polyps is the best colorectal cancer screening, according to the adenoma-carcinoma sequence. Recent studies have reported approximately 30% of interval cancer may be incomplete polyp resection. Complete polyp resection may be particularly important when implementing new methods for surveillance colonoscopies. Cold snare polypectomy (CSP) is considered to be a safer procedure for removing subcentimeter lesions than conventional hot snare polypectomy (HSP). CSP removal of polyps sized ≤5 mm have recommended by the European Society of Gastrointestinal Endoscopy guideline as the preferred technique. Previous report said that the complete resection rate of CSP for adenomatous polyps 4-9 mm in size was comparable to that of HSP, and in the foreseeable future CSP can be one of the standard techniques for 4-9 mm colorectal polyps. However, data on complete resection of colorectal polyps 1.0-1.5 mm in size is sparse. Investigators are interested in comparison of the resection rate of cold snare polypectomy for large (10-15 mm) and small (5-9 mm) colorectal polyps using CSP.
Read the detailed description
Participantswho meet inclusion criteria will be asked to participate, investigators will include all patients with resectable polyps, but only adenomatous polyps will be included for analysis. See also inclusion and exclusion criteria.
Colonoscopy, after bowel preparation with polyethylene glycol solution was performed using standard colonoscopes (CF-HQ290I, CF-Q260AI) and polypectomy snares(13mm Captivator and 10mm Captivator II).
All procedures were performed by experienced endoscopists (each with over 1000 colonoscopies performed) including CSP. All polyps between 5 and 15mm will be removed with a polypectomy snare. Polyp size will be measured using the tip of the snare catheter (2.5mm). Difficulty of resection will be grade by polyp resection time. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, for large lesions (10-15mm) 4 biopsies will be performed from all four quadrants of resection margins, for small lesions (5-9mm) biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue.
If polyp resection is complicated by bleeding (not self-sustained), no biopsies will be taken and any additional polyps that will be found during the remaining examination will be excluded from analysis. Severe bleeding that will complicate resection margins examination will be excluded from analysis, Endoscopic haemostasis will be performed when active haemorrhage continued for ≥30s.
A single research subject may have many eligible polyps. To avoid taking many biopsies, the investigators will not include more than 5 eligible polyps (the first 5 that are detected) per patient in the study.
Laboratory Analysis:
The polyps will be evaluated by experienced pathologists according to Vienna classification. Resection margins for each polyp will be recorded as: R0= adenomatous tissue free, R1=adenomatous tissue detection. Investigators will only include adenomatous polyps in the analysis. for financial requests of the resection margin biopsies. The pathological diagnosis of the biopsies will become part of the medical record. If biopsies contain adenomatous tissue the participants will be ask to return for a follow-up colonoscopy within six month.
- Conditions
- Adenomatous Polyps
- Being tested
- Cold snare polypectomy
- Keywords
- Cold snare polypectomy, Colorectal polyps, CARE Study
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold snare polypectomyOther
cold snare polypectomy (CSP), which does not include electrocautery to do a polypectomy with a snare
| Study group | Role | What they receive |
|---|---|---|
| small polyps | Active comparator | Cold snare polypectomy ; Polyp size will be measured using the tip of the snare catheter (2.5mm).Small (5-9 mm) colorectal polyps will be removed with a polypectomy snare. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue. Receives: Other: Cold snare polypectomy |
| large polyps | Experimental | Cold snare polypectomy; Polyp size will be measured using the tip of the snare catheter (2.5mm). Large (10-15 mm) colorectal polyps will be removed with a polypectomy snare. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, 4 biopsies will be performed from all four quadrants of resection margins. Receives: Other: Cold snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incomplete CSP resection rate of neoplastic polyps and subgroup analyses of possible factors that could contribute to an incomplete resection
Incomplete resection was presence of neoplastic tissue from histopathologic examination of polyp margin biopsies. Subgroup included polyp size (5-7mm/8 -9mm/10 -15mm), location (right/left side was defined proximal/distal to the splenic flexure), location with respect to colonic folds (between/on the fold or not), flat morphology (measured by the tip of the 2.4-mm snare catheter), en bloc vs piecemeal resection, a snare exclusively designed as a cold snare versus traditional polypectomy snare, Neoplastic polyps( Adenoma, sessile serrated adenomas/polyps, high-grade dysplasia), and ease of polyp resection (easy or 30s; moderately difficult or 30-60s, difficult or 60s).
Measured: six months
Secondary outcomes (2)
polypectomy procedure times
Time required for resection was defined as the time between the insertion of the snare into working channel to the end of polyp resection
Measured: six months
the rates of procedure-related complications
Delayed bleeding was defined as haemorrhage after colonoscopy requiring endoscopic haemostasis;submucosal disruption; perforation
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start3 Sep 2018
- Primary completion15 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adenomatous PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuqi He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuqi He, General Hospital of Beijing PLA Military Region
- Investigators
- tianyang zhang, Principal investigator, Medical department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647176
- Sponsor's protocol ID
- PLA GH-CSP-1
- Acronym
- CSP
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2018
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data can be seen after article been published
Publications
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.
PubMed 28970290Matsuura 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.
PubMed 28192823Ma X, Feng X, Li Y, Du Y, Wang J, Wu Y, Jin H, Xie X, Wang X, Jin P, Yang L, Wang H, Leung J, Sheng J, He Y. A Comparison of Incomplete Resection Rate of Large and Small Colorectal Polyps by Cold Snare Polypectomy. Clin Gastroenterol Hepatol. 2022 May;20(5):1163-1170. doi: 10.1016/j.cgh.2021.11.010. Epub 2021 Nov 17.
PubMed 34798334
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLA Army General Hospital of Beijing
- ClinicalTrials.gov ID
- NCT03647176
- Acronym / sponsor ID
- CSP / PLA GH-CSP-1
- Conditions
- Adenomatous Polyps
- Keywords
- Cold snare polypectomy, Colorectal polyps, CARE Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Yuqi HeUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer remains the third most common cause of death from cancer worldwide. Colonoscopy allows removal of adenomatous polyps is the best colorectal cancer screening, according to the adenoma-carcinoma sequence. Recent studies have reported approximately 30% of interval cancer may be incomplete polyp resection. Complete polyp resection may be particularly important when implementing new methods for surveillance colonoscopies. Cold snare polypectomy (CSP) is considered to be a safer procedure for removing subcentimeter lesions than conventional hot snare polypectomy (HSP). CSP removal of polyps sized ≤5 mm have recommended by the European Society of Gastrointestinal Endoscopy guideline as the preferred technique. Previous report said that the complete resection rate of CSP for adenomatous polyps 4-9 mm in size was comparable to that of HSP, and in the foreseeable future CSP can be one of the standard techniques for 4-9 mm colorectal polyps. However, data on complete resection of colorectal polyps 1.0-1.5 mm in size is sparse. Investigators are interested in comparison of the resection rate of cold snare polypectomy for large (10-15 mm) and small (5-9 mm) colorectal polyps using CSP.
Detailed description
Participantswho meet inclusion criteria will be asked to participate, investigators will include all patients with resectable polyps, but only adenomatous polyps will be included for analysis. See also inclusion and exclusion criteria.
Colonoscopy, after bowel preparation with polyethylene glycol solution was performed using standard colonoscopes (CF-HQ290I, CF-Q260AI) and polypectomy snares(13mm Captivator and 10mm Captivator II).
All procedures were performed by experienced endoscopists (each with over 1000 colonoscopies performed) including CSP. All polyps between 5 and 15mm will be removed with a polypectomy snare. Polyp size will be measured using the tip of the snare catheter (2.5mm). Difficulty of resection will be grade by polyp resection time. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, for large lesions (10-15mm) 4 biopsies will be performed from all four quadrants of resection margins, for small lesions (5-9mm) biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue.
If polyp resection is complicated by bleeding (not self-sustained), no biopsies will be taken and any additional polyps that will be found during the remaining examination will be excluded from analysis. Severe bleeding that will complicate resection margins examination will be excluded from analysis, Endoscopic haemostasis will be performed when active haemorrhage continued for ≥30s.
A single research subject may have many eligible polyps. To avoid taking many biopsies, the investigators will not include more than 5 eligible polyps (the first 5 that are detected) per patient in the study.
Laboratory Analysis:
The polyps will be evaluated by experienced pathologists according to Vienna classification. Resection margins for each polyp will be recorded as: R0= adenomatous tissue free, R1=adenomatous tissue detection. Investigators will only include adenomatous polyps in the analysis. for financial requests of the resection margin biopsies. The pathological diagnosis of the biopsies will become part of the medical record. If biopsies contain adenomatous tissue the participants will be ask to return for a follow-up colonoscopy within six month.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| small polyps | Active comparator | Other: Cold snare polypectomyCold snare polypectomy ; Polyp size will be measured using the tip of the snare catheter (2.5mm).Small (5-9 mm) colorectal polyps will be removed with a polypectomy snare. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue. |
| large polyps | Experimental | Other: Cold snare polypectomyCold snare polypectomy; Polyp size will be measured using the tip of the snare catheter (2.5mm). Large (10-15 mm) colorectal polyps will be removed with a polypectomy snare. Following the resection, jet stream of water will be used to wash mucosal defect thoroughly. After endoscopist's attestation that polyp removal was complete by carefully observe the resection margins with near focus mode, 4 biopsies will be performed from all four quadrants of resection margins. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥40 and <85
- Provide written informed consent
- Patients are found to have colorectal polyps between 5 and 15mm in size
Key exclusion criteria (7 listed)
- History of inflammatory bowel disease
- Polyposis of the alimentary tract
- Antiplatelet or anticoagulant therapy 5 days before the procedure
- Pregnancy
- Haemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold snare polypectomycold snare polypectomy (CSP), which does not include electrocautery to do a polypectomy with a snare | Other | large polyps, small polyps |
Primary outcome
incomplete CSP resection rate of neoplastic polyps and subgroup analyses of possible factors that could contribute to an incomplete resection
Time frame: six months
Incomplete resection was presence of neoplastic tissue from histopathologic examination of polyp margin biopsies. Subgroup included polyp size (5-7mm/8 -9mm/10 -15mm), location (right/left side was defined proximal/distal to the splenic flexure), location with respect to colonic folds (between/on the fold or not), flat morphology (measured by the tip of the 2.4-mm snare catheter), en bloc vs piecemeal resection, a snare exclusively designed as a cold snare versus traditional polypectomy snare, Neoplastic polyps( Adenoma, sessile serrated adenomas/polyps, high-grade dysplasia), and ease of polyp resection (easy or 30s; moderately difficult or 30-60s, difficult or 60s).
2 secondary outcomes
polypectomy procedure times
Time frame: six months
the rates of procedure-related complications
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Results publication: PubMed 28970290Kawamura 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.
- Results publication: PubMed 28192823Matsuura 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.
- Derived from this study: PubMed 34798334Ma X, Feng X, Li Y, Du Y, Wang J, Wu Y, Jin H, Xie X, Wang X, Jin P, Yang L, Wang H, Leung J, Sheng J, He Y. A Comparison of Incomplete Resection Rate of Large and Small Colorectal Polyps by Cold Snare Polypectomy. Clin Gastroenterol Hepatol. 2022 May;20(5):1163-1170. doi: 10.1016/j.cgh.2021.11.010. Epub 2021 Nov 17.
- Individual participant dataSharing planned: No. individual participant data can be seen after article been published
Related trials for Adenomatous Polyps
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
Recruiting
White Light, TXI, NBI and Computer-Aided Detection for Recurrence at Post-EMR Scars (PRINCESS)
Colorectal Polyps
Recruiting
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Colorectal Cancer, Colorectal Polyp
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tianyang zhang principal investigator
Medical department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold snare polypectomy in people with Adenomatous Polyps, run by Yuqi He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incomplete CSP resection rate of neoplastic polyps and subgroup analyses of possible factors that could contribute to an incomplete resection (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03647176, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.