10-20mm Colorectal PolypNCT05849623
Optimal Resection Technique for Medium-sized (10-20mm) Colorectal Polyps
A study testing Endoscopic Mucosal Resection (EMR), Cold Endoscopic Mucosal Resection (C-EMR) and Underwater Endoscopic Mucosal Resection (U-EMR) in people with 10-20mm Colorectal Polyp, run by Unity Health Toronto.
Trial summary
This study will investigate which resection technique (Endoscopic Mucosal Resection (EMR), cold EMR, or underwater EMR) leads to lower recurrence rates and less adverse events in patients with colorectal polyps (10-20mm). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 10-20mm Colorectal Polyp
- What is being tested?
- Endoscopic Mucosal Resection (EMR), Cold Endoscopic Mucosal Resection (C-EMR) and Underwater Endoscopic Mucosal Resection (U-EMR)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient (or a legally authorized representative) provides informed consent
- 18 years of age or older
- Completion of the endoscopist-recommended bowel preparation
- Presence of one eligible medium-sized polyp:
- 10-20 mm in size
- Paris classification of 0-IIa (flat, elevated lesion) on standard white light colonoscopy
- JNET Type 1 or 2A on magnifying Narrow Band Imaging (NBI) suspecting a sessile serrated lesion, adenoma, or adenoma with low-grade dysplasia.
Who cannot join
- Patient < 18 years old
- Inability to provide informed consent
- Inflammatory Bowel Disease,
- Familial Polyposis
- Pregnancy
- Incomplete bowel preparation
Show all 9Show fewer
- Patients with ineligible lesion:
- Paris classification of 0-Ip or 0-Is on standard white light colonoscopy,
- JNET Type 1 suspecting a hyperplastic polyp, or Type 2B or 3 suspecting a high- grade dysplasia or adenocarcinoma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optimal Resection Technique for Medium-sized (10-20mm) Colorectal Polyps: A Randomized Clinical Trial
This study will investigate which resection technique (Endoscopic Mucosal Resection (EMR), cold EMR, or underwater EMR) leads to lower recurrence rates and less adverse events in patients with colorectal polyps (10-20mm).
Read the detailed description
Endoscopic resection of colorectal polyps has previously been demonstrated to lower the incidence of colorectal cancer, a major cause of cancer-related mortality globally. By disrupting the progression of adenomas into carcinomas, polypectomy is essential in effectively lowering colorectal cancer mortality. There is currently a surplus of high-quality research on the best ways to remove large polyps (>20mm). For colorectal polyps of 10 to 20 mm, however, the best endoscopic resection method is unknown. Due to the lack of a standard polypectomy technique for the complete removal of medium-sized colorectal polyps, clinicians use a variety of methods according to their preferences and local resources. The historic gold standard of treatment for resecting polyps greater than 10 mm is hot endoscopic mucosal resection (EMR). The term "hot" refers to the use of electrocautery to cut through dense mucosal tissue, ablate remaining marginal dysplastic tissue, and prevent rapid bleeding through thermal vascular coagulation. However, adverse events such as perforation, prolonged bleeding, and post-polypectomy syndrome are all linked to electrocautery-induced damage. In contrast, cold snare polypectomy (CSP) and cold electrocautery minimal resection with injection (C-EMR-I) are alternative well-established techniques for the removal of polyps smaller than 10 mm, demonstrated to be associated with less delayed adverse effects than EMR. Underwater EMR (U-EMR), a novel technique developed in the last decade wherein water is instilled into the colon, allowing for submucosal fat to rise, elevating the lesion, and allowing mucosal resection in the absence of submucosal injectate. U-EMR may achieving higher en bloc resection rates, R0 resection rates, and lower recurrence rates. There are no specific recommendations for EMR of medium-sized polyps from gastroenterological and endoscopic societies globally.
The aim of this randomized control study is to compare the polyp recurrence rates and adverse events between cold snare EMR (C-EMR), hot EMR (H-EMR) and underwater EMR (U-EMR) for colorectal polyps in the size of 10-20mm.
- Conditions
- 10-20mm Colorectal Polyp
- Being tested
- Endoscopic Mucosal Resection (EMR), Cold Endoscopic Mucosal Resection (C-EMR), Underwater Endoscopic Mucosal Resection (U-EMR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Mucosal Resection (EMR)Procedure or surgery
EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.
Cold Endoscopic Mucosal Resection (C-EMR)Procedure or surgery
C-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.
Underwater Endoscopic Mucosal Resection (U-EMR)Procedure or surgery
U-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) | Active comparator | Patients will have an electrosurgical grounding pad attached, and an Erbe VIO electrosurgical unit will be adjusted to the endoscopist's preferred EndoCut Q and Coagulation settings. The polyp will be injected submucosally with a saline and methylene blue solution, with or without epinephrine at endoscopist's discretion. Using a 15mm snare connected to the electrosurgical unit, the resection will be performed, with the initial cut including a margin of normal mucosa and subsequent cuts to ensure no residual polyp tissue remains. In case of intraprocedural bleeding, snare tip soft coagulation (STSC) or coagulation forceps may be used. The resection site will be examined and any remaining polypoid tissue will be resected. Endoclips may be used to close the defect if there is significant intraprocedural bleeding. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet. Receives: Procedure: Endoscopic Mucosal Resection (EMR) |
| Cold Endoscopic Mucosal Resection (C-EMR) | Active comparator | The polyp will be positioned at the 6 o'clock position and injected submucosally with saline and methylene blue, with or without epinephrine. The size of the ensnared polyp will be limited to 10-15mm to make sure that the snare will cut through the tissue. If the snare encounters difficulty in cutting through, it will be loosened to release deeper tissue before being closed again. The base and margins of the resected polyp will be inspected for residual polyp, which will be resected using the same technique if found. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet. Receives: Procedure: Cold Endoscopic Mucosal Resection (C-EMR) |
| Underwater Endoscopic Mucosal Resection (U-EMR) | Active comparator | In the Underwater EMR arm, the patient will be connected to an electrosurgical grounding pad, and an Erbe VIO electrosurgical unit with EndoCut Q and Coagulation settings will be adjusted to the endoscopist's preference. Water, instead of carbon dioxide, will be used to fill the colon. Submucosal injection will not be performed.The patient will be positioned for optimal polyp exposure, and a 15mm snare will be used. The snare will be opened and positioned with a margin of normal mucosa and used to cut the polyp, en bloc if possible. Piecemeal resection should ensure no residual polyp tissue remains. Snare tip soft coagulation or coagulation forceps may be used for intraprocedural bleeding. The base and margins of the resected polyp will be inspected for residual polyp and resected if necessary. Closure of the defect with endoclips may be considered if there is significant bleeding. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet. Receives: Procedure: Underwater Endoscopic Mucosal Resection (U-EMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp Recurrence Rate
The primary outcome of this study is the polyp recurrence rate at follow-up between the three techniques. Recurrence is evaluated 6 to 12 months after initial colonoscopy with endoscopic evaluation and biopsy of the scar. If adenoma is suspected under high-definition white light and/or electronic/conventional chromoendoscopy, the operator will remove it by snare or bioptic forceps. Final histology will be used to define recurrence rate.
Measured: Polyp recurrence rate will be determined during the follow-up procedure performed 6-12 months after the initial colonoscopy.
Secondary outcomes (2)
Adverse Events
The secondary outcomes include the number of adverse events and time spent performing the resection technique. Adverse events are defined according to the ASGE lexicon for endoscopic AEs. Major adverse events, such as bleeding and perforation will be evaluated. Procedure-related bleeding is defined as hematochezia and/or melena requiring follow-up endoscopy for hemostasis or transfusion. Perforation is endoscopically diagnosed as a visible hole in the colon wall during the procedure or the presence of free air on abdominal imaging after the resection. The ASGE lexicon will be used for detailed definition and timing of AEs.
Measured: AEs will be evaluated in both the initial and follow-up procedures. The follow-up procedure will be performed 6-12 months after the initial colonoscopy. Relevant AEs that occur during the procedure and within one day post-procedure will be recorded.
Procedural time
Amount of time it takes to complete the colonoscopy (cecal intubation time and withdrawal time), and the amount of time taken to perform the resection technique. U-EMR start when the perimeter of the lesion is identified, and the device is fully inserted. C-EMR and EMR start at the time of injection. All techniques are considered finished when all lesion pieces are retrieved.
Measured: Completion times will be recorded at the time of procedure for both initial and follow-up colonoscopies (performed 6-12 months after the initial procedure). The time to complete the resection technique will be recorded during the first colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 10-20mm Colorectal PolypStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three study arms.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir Grover, Unity Health Toronto
- Investigators
- Kareem Khalaf, HBSc, MD, Study director, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849623
- Sponsor's protocol ID
- 23-041
- Status last verified
- May 2023
- First submitted
- 3 Apr 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Resection Technique for Medium-sized (10-20mm) Colorectal Polyps: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05849623
- Acronym / sponsor ID
- 23-041
- Conditions
- 10-20mm Colorectal Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 May 2023 (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.
This study will investigate which resection technique (Endoscopic Mucosal Resection (EMR), cold EMR, or underwater EMR) leads to lower recurrence rates and less adverse events in patients with colorectal polyps (10-20mm).
Detailed description
Endoscopic resection of colorectal polyps has previously been demonstrated to lower the incidence of colorectal cancer, a major cause of cancer-related mortality globally. By disrupting the progression of adenomas into carcinomas, polypectomy is essential in effectively lowering colorectal cancer mortality. There is currently a surplus of high-quality research on the best ways to remove large polyps (>20mm). For colorectal polyps of 10 to 20 mm, however, the best endoscopic resection method is unknown. Due to the lack of a standard polypectomy technique for the complete removal of medium-sized colorectal polyps, clinicians use a variety of methods according to their preferences and local resources. The historic gold standard of treatment for resecting polyps greater than 10 mm is hot endoscopic mucosal resection (EMR). The term "hot" refers to the use of electrocautery to cut through dense mucosal tissue, ablate remaining marginal dysplastic tissue, and prevent rapid bleeding through thermal vascular coagulation. However, adverse events such as perforation, prolonged bleeding, and post-polypectomy syndrome are all linked to electrocautery-induced damage. In contrast, cold snare polypectomy (CSP) and cold electrocautery minimal resection with injection (C-EMR-I) are alternative well-established techniques for the removal of polyps smaller than 10 mm, demonstrated to be associated with less delayed adverse effects than EMR. Underwater EMR (U-EMR), a novel technique developed in the last decade wherein water is instilled into the colon, allowing for submucosal fat to rise, elevating the lesion, and allowing mucosal resection in the absence of submucosal injectate. U-EMR may achieving higher en bloc resection rates, R0 resection rates, and lower recurrence rates. There are no specific recommendations for EMR of medium-sized polyps from gastroenterological and endoscopic societies globally.
The aim of this randomized control study is to compare the polyp recurrence rates and adverse events between cold snare EMR (C-EMR), hot EMR (H-EMR) and underwater EMR (U-EMR) for colorectal polyps in the size of 10-20mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three study arms.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) | Active comparator | Procedure: Endoscopic Mucosal Resection (EMR)Patients will have an electrosurgical grounding pad attached, and an Erbe VIO electrosurgical unit will be adjusted to the endoscopist's preferred EndoCut Q and Coagulation settings. The polyp will be injected submucosally with a saline and methylene blue solution, with or without epinephrine at endoscopist's discretion. Using a 15mm snare connected to the electrosurgical unit, the resection will be performed, with the initial cut including a margin of normal mucosa and subsequent cuts to ensure no residual polyp tissue remains. In case of intraprocedural bleeding, snare tip soft coagulation (STSC) or coagulation forceps may be used. The resection site will be examined and any remaining polypoid tissue will be resected. Endoclips may be used to close the defect if there is significant intraprocedural bleeding. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet. |
| Cold Endoscopic Mucosal Resection (C-EMR) | Active comparator | Procedure: Cold Endoscopic Mucosal Resection (C-EMR)The polyp will be positioned at the 6 o'clock position and injected submucosally with saline and methylene blue, with or without epinephrine. The size of the ensnared polyp will be limited to 10-15mm to make sure that the snare will cut through the tissue. If the snare encounters difficulty in cutting through, it will be loosened to release deeper tissue before being closed again. The base and margins of the resected polyp will be inspected for residual polyp, which will be resected using the same technique if found. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet. |
| Underwater Endoscopic Mucosal Resection (U-EMR) | Active comparator | Procedure: Underwater Endoscopic Mucosal Resection (U-EMR)In the Underwater EMR arm, the patient will be connected to an electrosurgical grounding pad, and an Erbe VIO electrosurgical unit with EndoCut Q and Coagulation settings will be adjusted to the endoscopist's preference. Water, instead of carbon dioxide, will be used to fill the colon. Submucosal injection will not be performed.The patient will be positioned for optimal polyp exposure, and a 15mm snare will be used. The snare will be opened and positioned with a margin of normal mucosa and used to cut the polyp, en bloc if possible. Piecemeal resection should ensure no residual polyp tissue remains. Snare tip soft coagulation or coagulation forceps may be used for intraprocedural bleeding. The base and margins of the resected polyp will be inspected for residual polyp and resected if necessary. Closure of the defect with endoclips may be considered if there is significant bleeding. The polyp will be retrieved (en bloc or piecemeal) using suction into a trap or RothNet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient (or a legally authorized representative) provides informed consent
- 18 years of age or older
- Completion of the endoscopist-recommended bowel preparation
- Presence of one eligible medium-sized polyp:
Key exclusion criteria (9 listed)
- Patient < 18 years old
- Inability to provide informed consent
- Inflammatory Bowel Disease,
- Familial Polyposis
- Pregnancy
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 Resection (EMR)EMR will be used to resect an eligible medium-sized polyp found in patients from this arm. | Procedure or surgery | Endoscopic Mucosal Resection (EMR) |
| Cold Endoscopic Mucosal Resection (C-EMR)C-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm. | Procedure or surgery | Cold Endoscopic Mucosal Resection (C-EMR) |
| Underwater Endoscopic Mucosal Resection (U-EMR)U-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm. | Procedure or surgery | Underwater Endoscopic Mucosal Resection (U-EMR) |
Primary outcome
Polyp Recurrence Rate
Time frame: Polyp recurrence rate will be determined during the follow-up procedure performed 6-12 months after the initial colonoscopy.
The primary outcome of this study is the polyp recurrence rate at follow-up between the three techniques. Recurrence is evaluated 6 to 12 months after initial colonoscopy with endoscopic evaluation and biopsy of the scar. If adenoma is suspected under high-definition white light and/or electronic/conventional chromoendoscopy, the operator will remove it by snare or bioptic forceps. Final histology will be used to define recurrence rate.
2 secondary outcomes
Adverse Events
Time frame: AEs will be evaluated in both the initial and follow-up procedures. The follow-up procedure will be performed 6-12 months after the initial colonoscopy. Relevant AEs that occur during the procedure and within one day post-procedure will be recorded.
Procedural time
Time frame: Completion times will be recorded at the time of procedure for both initial and follow-up colonoscopies (performed 6-12 months after the initial procedure). The time to complete the resection technique will be recorded during the first colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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.
Kareem Khalaf, HBSc, MD study director
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Mucosal Resection (EMR), Cold Endoscopic Mucosal Resection (C-EMR) and Underwater Endoscopic Mucosal Resection (U-EMR) in people with 10-20mm Colorectal Polyp, run by Unity Health Toronto.
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 7 inclusion and 9 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Samir Grover, MD, MEd, FRCPC (416-864-5628 ext. 3967, samir.grover@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyp Recurrence Rate (time frame: Polyp recurrence rate will be determined during the follow-up procedure performed 6-12 months after the initial colonoscopy.). 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 26 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.