Residual DiseaseNCT05117879
R0 Resection Rate Between CSP, cEMR and hEMR for 1-2 cm Colorectal SSLs
A study testing Cold snaring polypectomy/ Cold EMR/Hot EMR in people with Residual Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Colorectal cancer is the most prevalent cancer and the third cancer related death in Taiwan. Adenoma is a precancerous lesion of colorectal cancer. Using colonoscopy to detect and remove the adenoma has a chance to prevent colorectal cancer development. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Residual Disease
- What is being tested?
- Cold snaring polypectomy/ Cold EMR/Hot EMR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Dec 2020to 15 Jan 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 20 years old
- Indicated for colonoscopy and willing to receive colonoscopy examination and polyp resection。
- Any Sessile serrated adenoma size between 10-20mm was found during the examination。
Who cannot join
- Age younger than 20 years old
- Contraindication for colonoscopy or polypectomy (Such as recent acute myocardial infarction, pulmonary embolism ,coagulopathy..)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of R0 Resection Rate Between Cold Snare Polypectomy, Cold Endoscopic Mucosal Resection and Hot Endoscopic Mucosal Resection for 1-2 cm Colorectal Sessile Serrated Lesions: a Randomized Control Trial
Colorectal cancer is the most prevalent cancer and the third cancer related death in Taiwan. Adenoma is a precancerous lesion of colorectal cancer. Using colonoscopy to detect and remove the adenoma has a chance to prevent colorectal cancer development.
In the resection of colorectal polyps, for medium and large polyps that are more than one centimeter and less than two centimeters, because these polyps are at risk of cancer, they currently use hot-snaring polypectomy or more advanced endoscopic mucosal resection. Resection of such tumors ensures that a sufficient depth of resection and a high complete resection rate (R0 resection) are achieved.
Flat serrated adenoma (sessile serrated lesion) is a special adenoma that accounts for 10-12% of all colorectal polyps. Different from traditional adenomas, flat serrated adenomas within two centimeters in size have very little chance of becoming cancerous. And we know that on removal of medium and large polyps of 10-20mm, compared with the cold snaring polypectomy, the postoperative bleeding of the hot-snaring polypectomy technique is higher. Therefore, when removing low-risk polyps such as flat serrated adenomas, we may choose using a non-energized technique with low complications and we then would like to know whether the complete resection rate can be achieved by using the non-energized technique in the resection of a flat serrated adenoma of 10-20 mm, despite the large size, and compare the success rate and complications with traditional hot snaring polypectomy.
Read the detailed description
This study is a single-country, multi-center, randomized controlled study. The subjects of the case were patients who underwent colonoscopy for various indications and found flat serrated adenomas ranging in size from 10-20 mm during the procedure. Excluded criterias are patients who are younger than 20 years old and have contraindications for colonoscopy. All patients included in the study will sign the informed consent sheet at the outpatient clinic. Once a flat serrated adenoma with a size of 10-20 mm is found during colonoscopy, the subjects will be randomly assigned to Cold snaring polypectomy group, cold endoscopic mucosal resection group or hot endoscopic mucosal resection group.
The preoperative preparation for bowel cleansing and colonoscope insertion method for these three groups of patients are totally the same as those of general colonoscopy. The only difference is the resection method flat serrated glands of 10-20 mm. The tumor was resected by cold snaring polypectomy, one group was resected by cold endoscopic mucosal resection, and the other group was resected by hot endoscopic mucosal resection. The endoscopists participating in this research project have extensive experience in endoscopy and perform at least one hundred polypectomy operations every year. The excised tumor will be sent to the pathology department for pathological diagnosis, and the pathology doctor will judge the completeness of the tumor resection
- Conditions
- Residual Disease
- Being tested
- Cold snaring polypectomy/ Cold EMR/Hot EMR
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold snaring polypectomy/ Cold EMR/Hot EMRProcedure or surgery
Cold snaring polypectomy: The technique of cold snare polypectomy is used to remove [small colonic polyps] without diathermy, which implies that a polyp is transected by a snare along with a rim of surrounding normal mucosa.
Cold EMR: Cold EMR technique comprising submucosal injection of succinylated gelatin and dilute methylene blue before piecemeal cold snare resection of target polyp with a margin of normal tissue.
Hot EMR: Hot EMR technique comprising submucosal injection of succinylated gelatin and dilute methylene blue before piecemeal electrocautery snare resection of target polyp with a margin of normal tissue.
| Study group | Role | What they receive |
|---|---|---|
| Cold snaring polypectomy | Other | The sessile serrated adenoma size between 10-20mm would be resected by cold snaring polypectomy Receives: Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR |
| Non-electrocautery Endoscopic Mucosal Resection (Cold EMR) | Other | The sessile serrated adenoma size between 10-20mm would be resected by cold EMR Receives: Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR |
| Electrocautery Endoscopic Mucosal Resection( Hot EMR) | Other | The sessile serrated adenoma size between 10-20mm would be resected by Hot EMR Receives: Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
The margin of the resected specimen showed no adenoma involvement
Measured: within 14 days
Secondary outcomes (9)
Mean polypectomy time
Total time spent for polypectomy and hemostasis technique
Measured: within 1 hour
Successful tissue retrieval
The rate of successful tissue retrieval after polypectomy
Measured: 1 hour
Mean number of cuts
How many cuts to remove the lesion
Measured: 1 hour
En bloc resection
The rate of en bloc resection
Measured: 1 hour
Cut number
how many cuts to remove the lesion
Measured: 1 hour
Mean total procedure time
The total time of the colonoscopy, including polypectomy or EMR
Measured: 1 hour
Emergency service visit
Patient visit ER after polypectomy for any complication
Measured: within 14 days
Delayed bleeding rate
Bleeding occurs delayed from several hours to weeks after the polypectomy
Measured: within 14 days
Perforation rate
perforation after polypectomy or EMR
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start10 Dec 2020
- Primary completion28 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Model description
- Three groups: Cold snaring polypectomy, Cold EMR and Hot EMR
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
- Investigators
- Han-Mo Chiu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117879
- Sponsor's protocol ID
- 202008004RINC
- Status last verified
- Dec 2020
- First submitted
- 5 Nov 2020
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of R0 Resection Rate Between Cold Snare Polypectomy, Cold Endoscopic Mucosal Resection and Hot Endoscopic Mucosal Resection for 1-2 cm Colorectal Sessile Serrated Lesions: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05117879
- Acronym / sponsor ID
- 202008004RINC
- Conditions
- Residual Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 11 Nov 2021 (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 is the most prevalent cancer and the third cancer related death in Taiwan. Adenoma is a precancerous lesion of colorectal cancer. Using colonoscopy to detect and remove the adenoma has a chance to prevent colorectal cancer development.
In the resection of colorectal polyps, for medium and large polyps that are more than one centimeter and less than two centimeters, because these polyps are at risk of cancer, they currently use hot-snaring polypectomy or more advanced endoscopic mucosal resection. Resection of such tumors ensures that a sufficient depth of resection and a high complete resection rate (R0 resection) are achieved.
Flat serrated adenoma (sessile serrated lesion) is a special adenoma that accounts for 10-12% of all colorectal polyps. Different from traditional adenomas, flat serrated adenomas within two centimeters in size have very little chance of becoming cancerous. And we know that on removal of medium and large polyps of 10-20mm, compared with the cold snaring polypectomy, the postoperative bleeding of the hot-snaring polypectomy technique is higher. Therefore, when removing low-risk polyps such as flat serrated adenomas, we may choose using a non-energized technique with low complications and we then would like to know whether the complete resection rate can be achieved by using the non-energized technique in the resection of a flat serrated adenoma of 10-20 mm, despite the large size, and compare the success rate and complications with traditional hot snaring polypectomy.
Detailed description
This study is a single-country, multi-center, randomized controlled study. The subjects of the case were patients who underwent colonoscopy for various indications and found flat serrated adenomas ranging in size from 10-20 mm during the procedure. Excluded criterias are patients who are younger than 20 years old and have contraindications for colonoscopy. All patients included in the study will sign the informed consent sheet at the outpatient clinic. Once a flat serrated adenoma with a size of 10-20 mm is found during colonoscopy, the subjects will be randomly assigned to Cold snaring polypectomy group, cold endoscopic mucosal resection group or hot endoscopic mucosal resection group.
The preoperative preparation for bowel cleansing and colonoscope insertion method for these three groups of patients are totally the same as those of general colonoscopy. The only difference is the resection method flat serrated glands of 10-20 mm. The tumor was resected by cold snaring polypectomy, one group was resected by cold endoscopic mucosal resection, and the other group was resected by hot endoscopic mucosal resection. The endoscopists participating in this research project have extensive experience in endoscopy and perform at least one hundred polypectomy operations every year. The excised tumor will be sent to the pathology department for pathological diagnosis, and the pathology doctor will judge the completeness of the tumor resection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups: Cold snaring polypectomy, Cold EMR and Hot EMR
| Arm | Type | Receives |
|---|---|---|
| Cold snaring polypectomy | Other | Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMRThe sessile serrated adenoma size between 10-20mm would be resected by cold snaring polypectomy |
| Non-electrocautery Endoscopic Mucosal Resection (Cold EMR) | Other | Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMRThe sessile serrated adenoma size between 10-20mm would be resected by cold EMR |
| Electrocautery Endoscopic Mucosal Resection( Hot EMR) | Other | Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMRThe sessile serrated adenoma size between 10-20mm would be resected by Hot EMR |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 20 years old
- Indicated for colonoscopy and willing to receive colonoscopy examination and polyp resection。
- Any Sessile serrated adenoma size between 10-20mm was found during the examination。
Key exclusion criteria (2 listed)
- Age younger than 20 years old
- Contraindication for colonoscopy or polypectomy (Such as recent acute myocardial infarction, pulmonary embolism ,coagulopathy..)
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 snaring polypectomy/ Cold EMR/Hot EMRCold snaring polypectomy: The technique of cold snare polypectomy is used to remove [small colonic polyps] without diathermy, which implies that a polyp is transected by a snare along with a rim of surrounding normal mucosa. Cold EMR: Cold EMR technique comprising submucosal injection of succinylated gelatin and dilute methylene blue before piecemeal cold snare resection of target polyp with a margin of normal tissue. Hot EMR: Hot EMR technique comprising submucosal injection of succinylated gelatin and dilute methylene blue before piecemeal electrocautery snare resection of target polyp with a margin of normal tissue. | Procedure or surgery | Cold snaring polypectomy, Electrocautery Endoscopic Mucosal Resection( Hot EMR), Non-electrocautery Endoscopic Mucosal Resection (Cold EMR) |
Primary outcome
R0 resection rate
Time frame: within 14 days
The margin of the resected specimen showed no adenoma involvement
9 secondary outcomes
Mean polypectomy time
Time frame: within 1 hour
Successful tissue retrieval
Time frame: 1 hour
Mean number of cuts
Time frame: 1 hour
En bloc resection
Time frame: 1 hour
Cut number
Time frame: 1 hour
Mean total procedure time
Time frame: 1 hour
Emergency service visit
Time frame: within 14 days
Delayed bleeding rate
Time frame: within 14 days
Perforation rate
Time frame: two weeks
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 17 Oct 2024.
- 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.
Han-Mo Chiu, PhD principal investigator
National Taiwan University 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 Cold snaring polypectomy/ Cold EMR/Hot EMR in people with Residual Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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 17 Oct 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 Taiwan. 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?
R0 resection rate (time frame: within 14 days). 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 17 Oct 2024.