Colorectal Cancerh-APC_EMRNCT04015765
Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
A study testing Hybrid Argon Plasma Coagulation and EMR procedure in people with Colorectal Cancer and Polyp of Colon, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Endoscopic Mucosal Resection (EMR) is the current standard for effective endoscopic resection of such colon adenomas. If resection is possible in one piece (so-called "en bloc" resection) then recurrence rates are low. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Colorectal Cancer, Polyp of Colon
- What is being tested?
- Hybrid Argon Plasma Coagulation and EMR procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2019to 8 Jan 2025
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Ethnicity and race
- Patient referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm
- Written informed consent
Who cannot join
- Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- Previous partial EMR
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- Patients with inflammatory bowel disease
- Patients who are receiving an emergency colonoscopy
Show all 12Show fewer
- Poor general health (ASA class>3)
- Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
- Poor bowel preparation (Boston bowel prep score ≤2)
- Target sign or perforation during initial EMR
- Need for ESD for complete resection prior to APC
- Pregnancy and breast-feeding.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Montréal (CHUM)
Montreal, Quebec
About this study
Endoscopic Mucosal Resection (EMR) is the current standard for effective endoscopic resection of such colon adenomas. If resection is possible in one piece (so-called "en bloc" resection) then recurrence rates are low. However, most non-pedunculated polyps >2 cm are removed in pieces ("piece-meal" resection) which leads to disease recurrence rates between 12-30%. In the March 2019 issue of Gastroenterology Bourke et al. presented that post-EMR ablation of the resection margins using soft coagulation with the tip of a resection snare reduces adenoma recurrence to 5% compared to 21% recurrence found in the control group. Hybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift of dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications.
The study hypothesis is that routine use of hybrid Argon Plasma Coagulation (h-APC) for ablation of the post-EMR resection margins and resection surface area will reduce post-EMR adenoma recurrence to 5% or lower.
Read the detailed description
This is a prospective, multi-center study enrolling patients with non-pedunculated colorectal polyps ≥ 20mm for endoscopic mucosal resection (EMR). All primary EMR procedures will combine EMR with h-APC ablation of the base and margins after complete EMR resection to prevent adenoma recurrence.
Schedule of activities
- Enrollment visit before the endoscopy (ALL PATIENTS), in the outpatient clinic, or before the EMR. Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation before their scheduled procedure.
- EMR intervention (ALL PATIENTS meeting eligibility criteria). Only if a polyp meets inclusion criteria, the study subject will be enrolled. The standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is used as per the current standard of care using a contrast agent and a lifting agent (e.g., NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique is facilitated using standard microprocessor-controlled electrocautery. If residual polyp tissue cannot remove by a snare, other means such as cold snare (i.e., for small residual polyp tissue that cannot be engaged into standard snares), hot avulsion technique or Argon plasma coagulation or soft coagulation by the tip of snare can be used. The polyp site will be marked with submucosal injection of approximately 1-2cc of India ink (standard of care to mark lesions in the colon safely) to allow recognition at follow-up endoscopy. Polyps are sent to the pathology lab and evaluated according to standard practice by institutional pathologists.19 To determine the homogeneity and depth of h-APC margin ablation in the pathology lab, some ablated margins might be resected using the standard cold snare technique. Telephone calls or visits 14-30 days following the EMR will be conducted to assess possible adverse events.
- Follow-up 1 (FU1, ALL PATIENTS): colonoscopy 4 months (± 2 months) after the EMR intervention with the assessment of the primary outcome (biopsy/pathology-confirmed recurrence at post-EMR site). Patients with visible recurrence at the EMR site will undergo additional h-APC treatment for complete eradication at the first follow-up.
- Follow-up 2 (ONLY FOR PATIENTS with visible recurrence and biopsy confirmed recurrence at FU1 will undergo FU2 scheduled 4 months (± 2 months) after FU1 (within 1 year after EMR procedure) with the assessment of recurrence/complete eradication rates (biopsy/pathology confirmed complete eradication post-EMR and h-APC at FU1).
- Patients with not visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with h-APC treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of complete/incomplete eradication within 1 year after the initial EMR.
- Conditions
- Colorectal Cancer, Polyp of Colon
- Being tested
- Hybrid Argon Plasma Coagulation and EMR procedure
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Argon Plasma Coagulation and EMR procedureProcedure or surgery
Hybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications
| Study group | Role | What they receive |
|---|---|---|
| Group treatment h-APC and EMR | Experimental | Standard endoscopic mucosal resection (EMR) technique will be used for primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is used as per the current standard of care using a contrast agent and a lifting agent (e.g. NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique is facilitated using standard microprocessor controlled electrocautery (e.g. ERBE VIO Endocut 3-1-6). Ablation of the margin after visibly complete removal of the polyp is routinely applied. For thermal ablation hybrid APC (Erbe Hybrid APC) will be applied using standard settings on the margin and resection base. Once resection and thermal ablation is considered complete the mucosal defect can be closed with clips or another preventative measure applied to reduce the risk for post-polypectomy bleeding. Receives: Procedure: Hybrid Argon Plasma Coagulation and EMR procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-EMR recurrence at FU1
The post-EMR recurrence at FU1 is defined as the rate of first follow-up colonoscopies with found adenomas.
Measured: 4 months (+- 2 months) after the index h-APC and EMR procedure
Secondary outcomes (8)
Complete adenoma eradication rates
The complete adenoma eradication rate is defined as the rate of follow-up colonoscopies without any adenoma detected within 1 year after the index EMR, with potential re-ablation at FU1 for patients with visible or non-visible, but pathology confirmed adenoma recurrence.
Measured: Within 1 year after the index EMR
Incidence of complications
The rate of complications including bleeding, perforation, post polypectomy syndrome, and clinical events that require admission to the hospital.
Measured: 14 days after the index EMR
Severe bleeding complication rate
Rate of severe bleeding cases at the time of EMR resection, or during 14 days of follow-up. Immediate severe bleeding is defined as the inability to stop bleeding during the EMR procedure and the need for a non-endoscopic intervention (e.g., surgery or interventional radiology). Delayed severe bleeding is defined as the need for hospitalization, transfusion, a repeat colonoscopy or sigmoidoscopy, surgery, or interventional radiology.
Measured: 14 days after the index EMR
Perforation rate
Rate of colonoscopies with perforation, defined as a complete hole or full-thickness resection of the muscularis propria (Sidney Classification of Deep Mural Injury Type IV).
Measured: 14 days after the index EMR
Post-polypectomy syndrome incidence
Incidence rate of post-polypectomy syndrome, defined as abdominal pain severe enough to warrant an ED visit or hospital admission and presence of leukocytosis and/or required treatment with antibiotics.
Measured: 14 days after the index EMR
Completeness of polyp resection
Number of cases with completeness of thermal ablation of polyp resection margin, defined as the proportion of margins with at least one region of unablated margin as determined by histopathological evaluation of resected ablated margins.
Measured: 14 days after the index EMR
Intraprocedural bleeding rate
Rate of colonoscopies with immediate bleeding that requires endoscopic intervention to stop the bleeding (e.g., clip placement or soft snare coagulation).
Measured: During the procedures
Need for colon resection rate
Rate of patients who require surgery for polyp removal or as a result of complications related to the EMR or follow-up procedures.
Measured: Within 1 year after the index EMR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start26 Aug 2019
- Primary completion13 Dec 2024
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, University of Milan, Erbe Elektromedizin GmbH, Unity Health Toronto, University of British Columbia, Dartmouth-Hitchcock Medical Center, Froedtert Hospital, John Hopkins Hospital, Indiana University Health
- Responsible party
- Sponsor
- Investigators
- Daniel von Renteln, MD, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015765
- Sponsor's protocol ID
- CE.19.119
- Acronym
- h-APC_EMR
- Status last verified
- Mar 2025
- First submitted
- 4 Jul 2019
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Publications
Motchum L, Levenick JM, Djinbachian R, Moyer MT, Bouchard S, Taghiakbari M, Repici A, Deslandres E, von Renteln D. EMR combined with hybrid argon plasma coagulation to prevent recurrence of large nonpedunculated colorectal polyps (with videos). Gastrointest Endosc. 2022 Nov;96(5):840-848.e2. doi: 10.1016/j.gie.2022.06.018. Epub 2022 Jun 18.
PubMed 35724695
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
- ClinicalTrials.gov ID
- NCT04015765
- Acronym / sponsor ID
- h-APC_EMR / CE.19.119
- Conditions
- Colorectal Cancer, Polyp of Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Penn State University, University of Milan, Erbe Elektromedizin GmbH, Unity Health Toronto, University of British Columbia, Dartmouth-Hitchcock Medical Center, Froedtert Hospital, John Hopkins Hospital, Indiana University Health
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 11 Jul 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.
Endoscopic Mucosal Resection (EMR) is the current standard for effective endoscopic resection of such colon adenomas. If resection is possible in one piece (so-called "en bloc" resection) then recurrence rates are low. However, most non-pedunculated polyps >2 cm are removed in pieces ("piece-meal" resection) which leads to disease recurrence rates between 12-30%. In the March 2019 issue of Gastroenterology Bourke et al. presented that post-EMR ablation of the resection margins using soft coagulation with the tip of a resection snare reduces adenoma recurrence to 5% compared to 21% recurrence found in the control group. Hybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift of dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications.
The study hypothesis is that routine use of hybrid Argon Plasma Coagulation (h-APC) for ablation of the post-EMR resection margins and resection surface area will reduce post-EMR adenoma recurrence to 5% or lower.
Detailed description
This is a prospective, multi-center study enrolling patients with non-pedunculated colorectal polyps ≥ 20mm for endoscopic mucosal resection (EMR). All primary EMR procedures will combine EMR with h-APC ablation of the base and margins after complete EMR resection to prevent adenoma recurrence.
Schedule of activities
- Enrollment visit before the endoscopy (ALL PATIENTS), in the outpatient clinic, or before the EMR. Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation before their scheduled procedure.
- EMR intervention (ALL PATIENTS meeting eligibility criteria). Only if a polyp meets inclusion criteria, the study subject will be enrolled. The standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is used as per the current standard of care using a contrast agent and a lifting agent (e.g., NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique is facilitated using standard microprocessor-controlled electrocautery. If residual polyp tissue cannot remove by a snare, other means such as cold snare (i.e., for small residual polyp tissue that cannot be engaged into standard snares), hot avulsion technique or Argon plasma coagulation or soft coagulation by the tip of snare can be used. The polyp site will be marked with submucosal injection of approximately 1-2cc of India ink (standard of care to mark lesions in the colon safely) to allow recognition at follow-up endoscopy. Polyps are sent to the pathology lab and evaluated according to standard practice by institutional pathologists.19 To determine the homogeneity and depth of h-APC margin ablation in the pathology lab, some ablated margins might be resected using the standard cold snare technique. Telephone calls or visits 14-30 days following the EMR will be conducted to assess possible adverse events.
- Follow-up 1 (FU1, ALL PATIENTS): colonoscopy 4 months (± 2 months) after the EMR intervention with the assessment of the primary outcome (biopsy/pathology-confirmed recurrence at post-EMR site). Patients with visible recurrence at the EMR site will undergo additional h-APC treatment for complete eradication at the first follow-up.
- Follow-up 2 (ONLY FOR PATIENTS with visible recurrence and biopsy confirmed recurrence at FU1 will undergo FU2 scheduled 4 months (± 2 months) after FU1 (within 1 year after EMR procedure) with the assessment of recurrence/complete eradication rates (biopsy/pathology confirmed complete eradication post-EMR and h-APC at FU1).
- Patients with not visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with h-APC treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of complete/incomplete eradication within 1 year after the initial EMR.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group treatment h-APC and EMR | Experimental | Procedure: Hybrid Argon Plasma Coagulation and EMR procedureStandard endoscopic mucosal resection (EMR) technique will be used for primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is used as per the current standard of care using a contrast agent and a lifting agent (e.g. NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique is facilitated using standard microprocessor controlled electrocautery (e.g. ERBE VIO Endocut 3-1-6). Ablation of the margin after visibly complete removal of the polyp is routinely applied. For thermal ablation hybrid APC (Erbe Hybrid APC) will be applied using standard settings on the margin and resection base. Once resection and thermal ablation is considered complete the mucosal defect can be closed with clips or another preventative measure applied to reduce the risk for post-polypectomy bleeding. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All Ethnicity and race
- Patient referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm
- Written informed consent
Key exclusion criteria (12 listed)
- Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- Previous partial EMR
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- Patients with 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 |
|---|---|---|
| Hybrid Argon Plasma Coagulation and EMR procedureHybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications | Procedure or surgery | Group treatment h-APC and EMR |
Primary outcome
Post-EMR recurrence at FU1
Time frame: 4 months (+- 2 months) after the index h-APC and EMR procedure
The post-EMR recurrence at FU1 is defined as the rate of first follow-up colonoscopies with found adenomas.
8 secondary outcomes
Complete adenoma eradication rates
Time frame: Within 1 year after the index EMR
Incidence of complications
Time frame: 14 days after the index EMR
Severe bleeding complication rate
Time frame: 14 days after the index EMR
Perforation rate
Time frame: 14 days after the index EMR
Post-polypectomy syndrome incidence
Time frame: 14 days after the index EMR
Completeness of polyp resection
Time frame: 14 days after the index EMR
Intraprocedural bleeding rate
Time frame: During the procedures
Need for colon resection rate
Time frame: Within 1 year after the index EMR
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 Sep 2026.
- Derived from this study: PubMed 35724695Motchum L, Levenick JM, Djinbachian R, Moyer MT, Bouchard S, Taghiakbari M, Repici A, Deslandres E, von Renteln D. EMR combined with hybrid argon plasma coagulation to prevent recurrence of large nonpedunculated colorectal polyps (with videos). Gastrointest Endosc. 2022 Nov;96(5):840-848.e2. doi: 10.1016/j.gie.2022.06.018. Epub 2022 Jun 18.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
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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, PhD 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 Hybrid Argon Plasma Coagulation and EMR procedure in people with Colorectal Cancer and Polyp of Colon, 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 3 inclusion and 12 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 Sep 2026. 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?
Post-EMR recurrence at FU1 (time frame: 4 months (+- 2 months) after the index h-APC and EMR procedure). 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 NCT04015765, which also lists 1 linked publication.
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 Sep 2026.