Colorectal CancerNCT04548947
Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?
A study testing Cold snare polypectomy in conjunction with a submucosal injection in people with Colorectal Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This is a prospective, multi-endoscopist, single center, clinical study at tertiary referral center that addresses an important current challenge in the prevention of colorectal cancer (CRC), namely, how to improve the complete removal of CRC precursors. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cold snare polypectomy in conjunction with a submucosal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2021to 1 Jul 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed consent form; aged 45-80 years old, indication to undergo a colonoscopy
Who cannot join
- Known inflammatory bowel disease; active colitis; coagulopathy; familial polyposis syndrome; poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3; emergency colonoscopies, hospitalized patients or patients referred from the emergency room.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, multi-endoscopist, single center, clinical study at tertiary referral center that addresses an important current challenge in the prevention of colorectal cancer (CRC), namely, how to improve the complete removal of CRC precursors. This study will observe the potential benefit of specific polypectomy technique in conjunction with a systematic submucosal injection prior to the polyp resection. This study will evaluate the completeness and incompleteness of the resection of colorectal neoplastic polyps during the procedures.
Read the detailed description
Non-detection and incomplete resection of neoplastic colorectal polyps have been identified as the main risk factors for the development of CRC in patients after a colonoscopy. Between 7% and 9% of all newly diagnosed CRCs are estimated to be such "interval cancers," occurring after a previous colonoscopy and before the next surveillance examination. The vast majority of interval cancers are caused by incomplete detection or resection during colonoscopy examination. The contribution of incomplete resection towards interval cancer has recently been pointed out by a panel of experts as one of the cornerstones of CRC prevention that need to be addressed in future research studies. The primary aim of this study is to examine the incomplete adenoma resection rates when performing a cold snare polypectomy in conjunction with a submucosal injection for endoscopic resection of 4-20 mm non-pedunculated colorectal polyps. The subjects are patients, men and women, aged between 45-80 years old that are scheduled for a colonoscopy. The secondary aims are to identify procedure-related complication rates and patient-, polyp-, and endoscopist-related factors associated with incomplete adenoma resection.
- Conditions
- Colorectal Cancer
- Being tested
- Cold snare polypectomy in conjunction with a submucosal injection
- Keywords
- colorectal cancer, incomplete resection rate, submucosal injection, neoplastic polyps
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold snare polypectomy in conjunction with a submucosal injectionProcedure or surgery
The cold snare polypectomy in conjunction with a submucosal injection is a procedure during which the endoscopist resects the colorectal polyps during a colonoscopy, without any electrocautery.
| Study group | Role | What they receive |
|---|---|---|
| Cold snare polypectomy with a submucosal injection | Experimental | The procedure will include a cold snare polypectomy with a submucosal injection done prior to the resection. Receives: Procedure: Cold snare polypectomy in conjunction with a submucosal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incomplete resection rate (IRR)
The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.
Measured: Day 1
Secondary outcomes (5)
Immediate bleeding complications
bleeding requiring endoscopic intervention either during colonoscopy/polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission
Measured: Day 1
Delayed bleeding complications
bleeding after the end of the initial procedure 14 days later
Measured: 14 days after the initial procedure
Other severe complications
Post-polypectomy syndrome and perforation requiring endoscopic intervention and/or surgery, and/or hospital admission
Measured: 14 days after the initial procedure
Proportion of polyps considered interpretable for complete polyp removal
Proportion of polyps considered interpretable for complete polyp removal
Measured: 14 days after the initial procedure
Incomplete resection of colorectal polyps
Incomplete resection rates of colorectal polyps after widefield resection (defined as resection margins of the largest of 3mm or 25% of the resected polyp size) of 1-20mm polyps using SCALE-EYE as measurement tool vs standard non wide field polypectomy (defined by positive tissue remnants at biopsy sites [vertical and lateral margins, 4 biopsies])
Measured: 14 days after the initial procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start12 Jan 2021
- Primary completion1 Oct 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
- Masking
- None (open label)
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel von Renteln, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548947
- Sponsor's protocol ID
- 20.111
- Status last verified
- Dec 2022
- First submitted
- 8 Sep 2020
- Last updated
- 8 Dec 2022
- 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?
- ClinicalTrials.gov ID
- NCT04548947
- Acronym / sponsor ID
- 20.111
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, incomplete resection rate, submucosal injection, neoplastic polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 16 Sep 2020 (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 is a prospective, multi-endoscopist, single center, clinical study at tertiary referral center that addresses an important current challenge in the prevention of colorectal cancer (CRC), namely, how to improve the complete removal of CRC precursors. This study will observe the potential benefit of specific polypectomy technique in conjunction with a systematic submucosal injection prior to the polyp resection. This study will evaluate the completeness and incompleteness of the resection of colorectal neoplastic polyps during the procedures.
Detailed description
Non-detection and incomplete resection of neoplastic colorectal polyps have been identified as the main risk factors for the development of CRC in patients after a colonoscopy. Between 7% and 9% of all newly diagnosed CRCs are estimated to be such "interval cancers," occurring after a previous colonoscopy and before the next surveillance examination. The vast majority of interval cancers are caused by incomplete detection or resection during colonoscopy examination. The contribution of incomplete resection towards interval cancer has recently been pointed out by a panel of experts as one of the cornerstones of CRC prevention that need to be addressed in future research studies. The primary aim of this study is to examine the incomplete adenoma resection rates when performing a cold snare polypectomy in conjunction with a submucosal injection for endoscopic resection of 4-20 mm non-pedunculated colorectal polyps. The subjects are patients, men and women, aged between 45-80 years old that are scheduled for a colonoscopy. The secondary aims are to identify procedure-related complication rates and patient-, polyp-, and endoscopist-related factors associated with incomplete adenoma resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
| Arm | Type | Receives |
|---|---|---|
| Cold snare polypectomy with a submucosal injection | Experimental | Procedure: Cold snare polypectomy in conjunction with a submucosal injectionThe procedure will include a cold snare polypectomy with a submucosal injection done prior to the resection. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Signed consent form; aged 45-80 years old, indication to undergo a colonoscopy
Key exclusion criteria (1 listed)
- Known inflammatory bowel disease; active colitis; coagulopathy; familial polyposis syndrome; poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3; emergency colonoscopies, hospitalized patients or patients referred from the emergency room.
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 polypectomy in conjunction with a submucosal injectionThe cold snare polypectomy in conjunction with a submucosal injection is a procedure during which the endoscopist resects the colorectal polyps during a colonoscopy, without any electrocautery. | Procedure or surgery | Cold snare polypectomy with a submucosal injection |
Primary outcome
Incomplete resection rate (IRR)
Time frame: Day 1
The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.
5 secondary outcomes
Immediate bleeding complications
Time frame: Day 1
Delayed bleeding complications
Time frame: 14 days after the initial procedure
Other severe complications
Time frame: 14 days after the initial procedure
Proportion of polyps considered interpretable for complete polyp removal
Time frame: 14 days after the initial procedure
Incomplete resection of colorectal polyps
Time frame: 14 days after the initial procedure
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 8 Dec 2022.
- 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.
Daniel von Renteln, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 conjunction with a submucosal injection in people with Colorectal Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 inclusion and 1 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 8 Dec 2022. 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 Canada. 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 resection rate (IRR) (time frame: Day 1). 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 8 Dec 2022.