Colonic DiseaseEMR+APCNCT06435377
Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions
An observational study of Colonic Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Disease
- What is being tested?
- Procedure: Cold EMR + APC
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 30 Jun 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.
Who may be able to join
- All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
- Lesions of 20 mm and larger.
- All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
- Patients who were able to provide written informed consent
Who cannot join
- Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
- Lesions with a wide Paris 0-Is component (>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
- Pedunculated polyps
- Active/quiescent colitis
- Rectal lesions
- Residual or recurrent adenoma after endoscopic mucosal resection
Trial locations and contacts
1 site in 1 country.
Italy1 site
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milano, 20089
About this study
Official title: Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS
This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.
- Conditions
- Colonic Disease
- Being tested
- Procedure: Cold EMR + APC
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Cold EMR + APCProcedure or surgery
- Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare
- Biopsy of the resection bed
- Ablation of the defect using argon plasma coagulation (APC).
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual
Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.
Measured: 1 day
Recurrence
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.
Measured: 1 year
Secondary outcomes (5)
Efficacy of procedure
Complete resection of polyp
Measured: 1 day
Rate of delayed bleeding of the patient
Delayed-bleeding, defined was defined as clinical evidence of bleeding (hematemesis, hematochezia or melena or a decrease of hemoglobin concentration > 2g/dL, which required transfusion or endoscopic reintervention with hemostasis within 30 days of hospital discharge)
Measured: 1 day
Rate of post-polipectomy syndrome
The post-polipectomy syndrome is defined by the presence of fever or abdominal pain
Measured: 1 day
perforation
Rate of perforation and delayed perforation
Measured: 1 day
Time
Average time of procedure and polyp resection time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435377
- Sponsor's protocol ID
- Cold-EMR plus APC
- Acronym
- EMR+APC
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS
- ClinicalTrials.gov ID
- NCT06435377
- Acronym / sponsor ID
- EMR+APC / Cold-EMR plus APC
- Conditions
- Colonic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 May 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.
This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.
Key inclusion criteria (4 listed)
- All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
- Lesions of 20 mm and larger.
- All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
- Patients who were able to provide written informed consent
Key exclusion criteria (6 listed)
- Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
- Lesions with a wide Paris 0-Is component (>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
- Pedunculated polyps
- Active/quiescent colitis
- Rectal lesions
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 |
|---|---|---|
| Procedure: Cold EMR + APC* Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare * Biopsy of the resection bed * Ablation of the defect using argon plasma coagulation (APC). | Procedure or surgery | – |
Primary outcome
Residual
Time frame: 1 day
Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.
Recurrence
Time frame: 1 year
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.
5 secondary outcomes
Efficacy of procedure
Time frame: 1 day
Rate of delayed bleeding of the patient
Time frame: 1 day
Rate of post-polipectomy syndrome
Time frame: 1 day
perforation
Time frame: 1 day
Time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
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 4 inclusion and 6 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 30 May 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 Italy. 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?
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?
Residual (time frame: 1 day). The study lists 2 primary outcomes in all. 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 30 May 2024.