Colorectal Sessile Serrated LesionNCT06609031
EMR Versus CSP in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size
A study testing endoscopic mucosal resection and Cold snare polypectomy in people with Colorectal Sessile Serrated Lesion, run by Fudan University at 1 site in China.
Trial summary
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Colorectal Sessile Serrated Lesion
- What is being tested?
- endoscopic mucosal resection and Cold snare polypectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2026
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 35 and 75 years
- Suspected sessile serrated lesions less than 10mm in size in screening, surveillance or therapeutic colonoscopy
- 0-Is or 0-IIa according to Paris classification
- Type 1 according to NICE and JNET classification
- Type II according to pit pattern
- Patients must sign an informed consent form prior to registration in study
Who cannot join
- Unsuitable for removal by EMR or CSP
- Suspected dysplasia or malignancy
- Recurrent sessile serrated lesions after endoscopic resection
- Familial adenomatous polyposis, Lynch syndrome or serrated polyposis syndrome
- History of inflammatory bowel disease
- Patients taking anticoagulant and antiplatelet agents before the examination
- Severe illness or other high-risk conditions that prevent the patient from cooperating with or tolerating endoscopic therapy
- Refusal to sign the informed consent form or any other factors that are not suitable for enrollment or affect the ability to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Huadong hospital affiliated to Fudan university
Shanghai, 200040
Danian Ji, M.D., +86-18019094606, arctg4@163.com
About this study
Official title: Endoscopic Mucosal Resection Versus Cold Snare Polypectomy in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size: a Single-center, Open-label, Randomized Controlled Trial
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size.
Read the detailed description
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients with suspicious sessile serrated lesions (SSLs) less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Endoscopic mucosal resection (EMR) and (2) Group 2: Cold snare polypectomy (CSP).
- Collecting variables which consist of primary and secodary outcomes.
- Conditions
- Colorectal Sessile Serrated Lesion
- Being tested
- endoscopic mucosal resection, Cold snare polypectomy
- Keywords
- Sessile Serrated Lesion, cold snare polypectomy, endoscopic mucosal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic mucosal resectionProcedure or surgery
The SSLs less than 10mm in size in this group will be treated by EMR
Cold snare polypectomyProcedure or surgery
The SSLs less than 10mm in size in this group will be treated by CSP
| Study group | Role | What they receive |
|---|---|---|
| EMR in treating SSLs less than 10mm in size | Experimental | The EMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery Receives: Procedure: endoscopic mucosal resection |
| CSP in treating SSLs less than 10mm in size | Active comparator | The CSP procedure included the following: (1) entrapment and resection of the polyp with a snare without electrocautery. Receives: Procedure: Cold snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection
Rate of R0 resection in treating SSLs less than 10mm in size
Measured: 2 weeks after the procedure
Secondary outcomes (8)
en bloc resection
Rate of en bloc resection rate in treating SSLs less than 10mm in size
Measured: immediately after the procedure
Vertical margins
Rate of negative vertical margins in resected specimen
Measured: 2 weeks after the procedure
Lateral margin
Rate of negative lateral margin in resected specimen
Measured: 2 weeks after the procedure
Presence of muscularis mucosae
Rate of presence of muscularis mucosae in resected specimen
Measured: 2 weeks after the procedure
Presence of submucosa
Rate of presence of submucosa in resected specimen
Measured: 2 weeks after the procedure
Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）
CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis
Measured: immediately after the procedure
Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）
CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
Measured: 2 weeks after the procedure
Delayed perforation
Rate of delayed perforation in treating SSLs less than 10mm in size
Measured: 2 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Sessile Serrated LesionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Danian Ji, M.D., Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609031
- Sponsor's protocol ID
- 2024K225
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Mucosal Resection Versus Cold Snare Polypectomy in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size: a Single-center, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06609031
- Acronym / sponsor ID
- 2024K225
- Conditions
- Colorectal Sessile Serrated Lesion
- Keywords
- Sessile Serrated Lesion, cold snare polypectomy, endoscopic mucosal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size.
Detailed description
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients with suspicious sessile serrated lesions (SSLs) less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Endoscopic mucosal resection (EMR) and (2) Group 2: Cold snare polypectomy (CSP).
- Collecting variables which consist of primary and secodary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR in treating SSLs less than 10mm in size | Experimental | Procedure: endoscopic mucosal resectionThe EMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery |
| CSP in treating SSLs less than 10mm in size | Active comparator | Procedure: Cold snare polypectomyThe CSP procedure included the following: (1) entrapment and resection of the polyp with a snare without electrocautery. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 35 and 75 years
- Suspected sessile serrated lesions less than 10mm in size in screening, surveillance or therapeutic colonoscopy
- 0-Is or 0-IIa according to Paris classification
- Type 1 according to NICE and JNET classification
- Type II according to pit pattern
Key exclusion criteria (8 listed)
- Unsuitable for removal by EMR or CSP
- Suspected dysplasia or malignancy
- Recurrent sessile serrated lesions after endoscopic resection
- Familial adenomatous polyposis, Lynch syndrome or serrated polyposis syndrome
- History of inflammatory bowel disease
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 |
|---|---|---|
| endoscopic mucosal resectionThe SSLs less than 10mm in size in this group will be treated by EMR | Procedure or surgery | EMR in treating SSLs less than 10mm in size |
| Cold snare polypectomyThe SSLs less than 10mm in size in this group will be treated by CSP | Procedure or surgery | CSP in treating SSLs less than 10mm in size |
Primary outcome
R0 resection
Time frame: 2 weeks after the procedure
Rate of R0 resection in treating SSLs less than 10mm in size
8 secondary outcomes
en bloc resection
Time frame: immediately after the procedure
Vertical margins
Time frame: 2 weeks after the procedure
Lateral margin
Time frame: 2 weeks after the procedure
Presence of muscularis mucosae
Time frame: 2 weeks after the procedure
Presence of submucosa
Time frame: 2 weeks after the procedure
Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）
Time frame: immediately after the procedure
Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）
Time frame: 2 weeks after the procedure
Delayed perforation
Time frame: 2 weeks after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Danian Ji, M.D. study director
Huadong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic mucosal resection and Cold snare polypectomy in people with Colorectal Sessile Serrated Lesion, run by Fudan University 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 6 inclusion and 8 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 25 Sep 2024. 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 Danian Ji, M.D. (+86-18019094606, arctg4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection (time frame: 2 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2024.