Adenomatous PolypsNCT04061005
A Comparison of the Resection Rate for Cold and Hot Snare Polypectomy for 5-15 mm Colorectal Polyps
A study testing Cold snare polypectomy, Hot snare polypectomy and Endoscopic margin observation method in people with Adenomatous Polyps, run by Yuqi He at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- Cold snare polypectomy, Hot snare polypectomy and Endoscopic margin observation method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2018to 20 Oct 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient ≥40 and <70 years old
- 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.
tianyang zhang contact
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, 7th medical center of PLA general hospital
Beijing, Dongcheng District, 100700
yuqi he, +801066721299, endohe@163.com
About this study
Official title: 7th Medical Center of PLA General Hospital
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.
Read the detailed description
Participants who 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 (GIF-HQ290I) and polypectomy snares.
All procedures were performed by experienced endoscopists(each with over 1000 colonoscopies performed) including CSP and HSP. All patients with a colorectal 5-15 mm polyp detected will be randomized to receive HSP and CSP treatment. 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(4-9mm) biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue. 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(4-9mm) 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.
- Conditions
- Adenomatous Polyps
- Being tested
- Cold snare polypectomy, Hot snare polypectomy, Endoscopic margin observation method
- Keywords
- Cold snare polypectomy, Hot snare polypectomy, Colorectal polyps, CARE Study, Complete resection rate
- 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 polypectomyProcedure or surgery
CSP, which does not include electrocautery to do a polypectomy with a snare.
Hot snare polypectomyProcedure or surgery
HSP, which uses the electrocautery to do a polypectomy with a snare.
Endoscopic margin observation methodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hot snare polypectomy (HSP) | Active comparator | The 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. Receives: Procedure: Hot snare polypectomy; Procedure: Endoscopic margin observation method |
| Cold snare polypectomy (CSP) | Experimental | The 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. Receives: Procedure: Cold snare polypectomy; Procedure: Endoscopic margin observation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (6)
Methodological evaluation of Endoscopic margin observation method
After polypectomy, the operating assistant unfolded the retrieved polyp specimen in the natural shape and pinned flat on a cork board according to the ESD specimen fixation method. Then endoscopic view judged the margin of the unfolded polyp.If a complete normal mucosal margin is visible, it is considered a complete resection. Then, the complete resection rate of the method was compared with the complete resection rate of the traditional pathological biopsy to judge the accuracy of the method.
Measured: six months
Polyp retrieval rate
Polyp specimens retrieval rate
Measured: six months
Number of additional resections (snaring and/or biopsy)
snaring and/or biopsy
Measured: six months
Rate of difficult/impossible resection by CSP
Difficult CSP resection was defined as a resection procedure that required ≥5s after snaring.An impossible CSP resection was defined as a resection procedure that needed high-frequency electric current.
Measured: six months
Time required for resection
Time required for resection was defined as the time between the insertion of the snare into working channel to the end of polyp resection. The time was measured by endoscopists or assistant by using stopwatch that was built in the endoscopic system. When submucosal injection was conducted in the HSP group, the time required for resection was measured from the insertion of the injection needle into the working channel until 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. It should be noted that, if vascular stump is found on the wound surface after HSP, electrocoagulation treatment is required and the probability is recorded.After CSP, it is necessary to observe whether there is active bleeding.Titanium clips were not used for hemostasis in both groups.
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 posted19 Aug 2019
- Study start20 Aug 2018
- Primary completion20 Oct 2022 (estimated)
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
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
- NCT04061005
- Sponsor's protocol ID
- PLA HSP-CSP-1
- Status last verified
- Feb 2021
- First submitted
- 29 Jul 2019
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28192823
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7th Medical Center of PLA General Hospital
- ClinicalTrials.gov ID
- NCT04061005
- Acronym / sponsor ID
- PLA HSP-CSP-1
- Conditions
- Adenomatous Polyps
- Keywords
- Cold snare polypectomy, Hot snare polypectomy, Colorectal polyps, CARE Study, Complete resection rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Yuqi HeUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 19 Aug 2019 (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.
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.
Detailed description
Participants who 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 (GIF-HQ290I) and polypectomy snares.
All procedures were performed by experienced endoscopists(each with over 1000 colonoscopies performed) including CSP and HSP. All patients with a colorectal 5-15 mm polyp detected will be randomized to receive HSP and CSP treatment. 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(4-9mm) biopsies were performed from two marginal sites located symmetrically on the left and right of the mucosal defects to confirm residual polyp tissue. 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(4-9mm) 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot snare polypectomy (HSP) | Active comparator | Procedure: Hot snare polypectomy, Procedure: Endoscopic margin observation methodThe 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) | Experimental | Procedure: Cold snare polypectomy, Procedure: Endoscopic margin observation methodThe 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥40 and <70 years old
- 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 polypectomyCSP, which does not include electrocautery to do a polypectomy with a snare. | Procedure or surgery | Cold snare polypectomy (CSP) |
| Hot snare polypectomyHSP, which uses the electrocautery to do a polypectomy with a snare. | Procedure or surgery | Hot snare polypectomy (HSP) |
| Endoscopic margin observation methodEndoscopic 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. | Procedure or surgery | Cold snare polypectomy (CSP), Hot snare polypectomy (HSP) |
Primary outcome
Complete resection rate
Time frame: six months
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.
6 secondary outcomes
Methodological evaluation of Endoscopic margin observation method
Time frame: six months
Polyp retrieval rate
Time frame: six months
Number of additional resections (snaring and/or biopsy)
Time frame: six months
Rate of difficult/impossible resection by CSP
Time frame: six months
Time required for resection
Time frame: six months
The rates of procedure-related complications
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- 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.
- Individual participant dataSharing planned: No
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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 contact
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, Hot snare polypectomy and Endoscopic margin observation method 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuqi he, doctor (+801066721299, endohe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection rate (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 NCT04061005, which also lists 2 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 17 Aug 2021.