h-APC Margin Ablation for Colon Polyps

(h-APC_EMR Trial)

No longer recruiting at 1 trial location

Overseen By Julie Fleury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Invasive carcinoma, Inflammatory bowel disease, Poor health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to prevent the return of colon polyps after removal. It tests hybrid Argon Plasma Coagulation (h-APC), which uses heat and water pressure to treat the area where the polyp was removed. The goal is to reduce the recurrence rate of polyps to 5% or less. Suitable candidates for this trial have non-mushroom-shaped colon polyps that are 20 mm or larger and require removal. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could significantly enhance future colon polyp treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a coagulopathy (a condition affecting blood clotting) with an elevated INR (a measure of blood clotting) or low platelets, you may not be eligible to participate.

What prior data suggests that this technique is safe for colon polyp removal?

Research has shown that combining endoscopic mucosal resection (EMR) and hybrid Argon Plasma Coagulation (h-APC) offers a promising method for removing large colon polyps. EMR is already effective and safe, successfully removing polyps in most patients without major side effects.

Early results for h-APC suggest it enhances safety. This method carefully controls the depth of heat penetration into the tissue, helping to prevent complications. Studies report a low risk of side effects due to this precise control.

Overall, both treatments in this trial are well-tolerated, with few adverse effects reported. This combination presents a potentially safe option for reducing the recurrence of colon polyps after removal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the h-APC Margin Ablation technique because it enhances the standard polyp removal process by adding a step of thermal ablation to the margins after the polyp has been removed. Unlike traditional methods, which often rely solely on endoscopic mucosal resection (EMR), this technique uses hybrid argon plasma coagulation (h-APC) to target and potentially destroy any remaining polyp tissue at the resection site. This added step aims to reduce the risk of polyp recurrence and improve patient outcomes by offering a more thorough treatment option.

What evidence suggests that hybrid Argon Plasma Coagulation is effective for reducing adenoma recurrence after EMR?

In this trial, participants will receive a combination of treatments involving the standard endoscopic mucosal resection (EMR) technique followed by hybrid Argon Plasma Coagulation (h-APC). Research has shown that using h-APC after removing colon polyps can greatly lower the chance of recurrence. One study found that h-APC reduced the recurrence rate to 5%, compared to 21% in a group that did not use this method. This technique uses heat and a water spray to safely and thoroughly treat the area where the polyp was removed. It not only treats the surface but also reaches deeper tissues, potentially resulting in fewer side effects. Overall, these findings suggest that h-APC could be a promising way to prevent colon polyps from returning after removal. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel von Renteln, MD, PhD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for patients needing removal of large, non-pedunculated colorectal polyps (≥20 mm) and who can provide consent. It's open to all ethnicities and races but excludes those with invasive carcinoma in the study polyp, prior partial EMR, certain lesion types, severe health issues (ASA class>3), pregnant or breastfeeding individuals, inflammatory bowel disease sufferers, emergency cases, coagulopathy or poor bowel preparation.

Inclusion Criteria

People of all ethnicities and races are eligible to participate.

Written informed consent

I am referred for a procedure to remove large non-pedunculated polyps in my colon.

Exclusion Criteria

Pedunculated polyps (as defined by Paris Classification type Ip or Isp)

Poor bowel preparation (Boston bowel prep score ≤2)

I am undergoing an emergency colonoscopy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Endoscopic Mucosal Resection (EMR) combined with hybrid Argon Plasma Coagulation (h-APC) for ablation of the resection margins

1 day

1 visit (in-person)

Follow-up 1

Colonoscopy to assess recurrence and perform additional h-APC treatment if necessary

4 months (± 2 months)

1 visit (in-person)

Follow-up 2

Additional colonoscopy for patients with recurrence to assess eradication rates

4 months (± 2 months) after Follow-up 1

1 visit (in-person)

Long-term Follow-up

Monitoring for complete adenoma eradication and complications within 1 year after the initial EMR

1 year

What Are the Treatments Tested in This Trial?

Interventions

• EMR procedure
• Hybrid Argon Plasma Coagulation

Trial Overview The trial tests Hybrid Argon Plasma Coagulation (h-APC) after Endoscopic Mucosal Resection (EMR) for colon adenomas. h-APC aims to reduce recurrence by lifting the mucosa with saline injection before ablation. This follows evidence that margin ablation post-EMR significantly lowers adenoma recurrence rates.

How Is the Trial Designed?

Group I: Group treatment h-APC and EMR Experimental Treatment 1 Intervention

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.

EMR procedure is already approved in European Union, United States for the following indications:

Approved in European Union as EMR procedure for:

• Colorectal polyps
• Adenomas
• Sessile serrated lesions
• Adenocarcinomas

Approved in United States as EMR procedure for:

• Colorectal polyps
• Adenomas
• Sessile serrated lesions
• Adenocarcinomas

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Dr John levenick

Collaborator

Trials

1

Recruited

380+

Dr Alessandro Repici

Collaborator

Trials

1

Recruited

380+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

University of Milan

Collaborator

Trials

268

Recruited

307,000+

Erbe Elektromedizin GmbH

Industry Sponsor

Trials

14

Recruited

840+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Published Research Related to This Trial

In a pilot study involving 40 patients, the novel hybrid argon plasma coagulation-assisted EMR (hAPC-EMR) technique showed a 0% local recurrence rate of large, sessile colon polyps after 6 months, indicating high efficacy.

The safety profile of hAPC-EMR was favorable, with only 7.5% of patients experiencing post-polypectomy bleeding and no cases of post-polypectomy syndrome reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid argon plasma coagulation-assisted endoscopic mucosal resection for large sessile colon polyps to reduce local recurrence: a prospective pilot study. Motz, VL., Lester, C., Moyer, MT., et al.[2023]

Carbon ion therapy offers precise targeting of tumors through the spread out Bragg peak, which maximizes energy delivery to the tumor while minimizing damage to surrounding healthy tissues.

This therapy is particularly effective against radioresistant tumors, making it a preferred option for treating non-resectable tumors that pose a local threat, as it has a higher biological efficiency compared to traditional X-rays or protons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Particle therapy: carbon ions]. Pommier, P., Hu, Y., Baron, MH., et al.[2018]

Carbon-ion radiotherapy (C-ion RT) demonstrated long-term efficacy for treating oral mucosal malignant melanoma (OMM), with 5-year local control, overall survival, and progression-free survival rates of 89.5%, 57.4%, and 51.6%, respectively, based on a study of 19 patients followed for a median of 61 months.

While C-ion RT showed effectiveness, it also had some associated risks, including grade 2 and 3 osteoradionecrosis in a number of patients, particularly those with teeth in the treatment area, highlighting the need for careful planning in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes after carbon-ion radiotherapy for oral mucosal malignant melanoma. Naganawa, K., Koto, M., Takagi, R., et al.[2020]

Carbon ion radiotherapy (RT) demonstrated high efficacy in treating chordomas and low-grade chondrosarcomas, achieving 100% local control for chondrosarcomas and 87% for chordomas at a 3-year follow-up with a median follow-up of 15 months.

The treatment was safe, with no severe side effects observed, and indicated potential for higher biological effectiveness of carbon ions, as evidenced by partial tumor remission in 31% of chordoma patients and 17% of chondrosarcoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon ion radiotherapy for chordomas and low-grade chondrosarcomas of the skull base. Results in 67 patients. Schulz-Ertner, D., Nikoghosyan, A., Thilmann, C., et al.[2019]

In a study of 11 patients with locally advanced hepatocellular carcinoma (HCC), carbon ion radiotherapy (C-ion RT) demonstrated a 3-year overall survival rate of 64% and a local control rate of 78%, indicating its effectiveness in managing this challenging condition.

C-ion RT was well-tolerated, with no patients experiencing severe toxicities or radiation-induced liver diseases, suggesting it is a safe treatment option for patients with LAHCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of Hypofractionated carbon ion radiotherapy on locally advanced hepatocellular carcinoma. Shiba, S., Shibuya, K., Okamoto, M., et al.[2021]

Argon plasma coagulation (APC) is a safe and effective alternative treatment for superficial esophageal cancer in patients who cannot undergo endoscopic mucosal resection (EMR), with no incidents of bleeding or infection reported in a study of 10 patients.

While APC is easier to perform and has a lower risk of complications compared to EMR, it is less effective in achieving complete resection of cancerous lesions, making it suitable only for specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation for the treatment of superficial esophageal carcinoma. Nomura, T., Miyashita, M., Makino, H., et al.[2019]

In a study involving 101 colorectal polyps from 84 patients, the use of hybrid argon plasma coagulation (h-APC) after endoscopic mucosal resection (EMR) resulted in a very low recurrence rate of only 2.2% during follow-up colonoscopies.

The procedure demonstrated a high technical success rate with minimal serious adverse events, indicating that EMR with h-APC is a safe and effective method for managing large colorectal polyps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMR combined with hybrid argon plasma coagulation to prevent recurrence of large nonpedunculated colorectal polyps (with videos). Motchum, L., Levenick, JM., Djinbachian, R., et al.[2022]

In a study of 23 elderly patients (average age 77.5 years) with early gastric cancer, argon plasma coagulation (APC) was found to be a safe and effective treatment option, especially for those who could not undergo surgery or had unsuccessful EMR.

After a median follow-up of 42 months, 15 patients showed no recurrence of cancer, and APC was successfully used to manage recurrences without serious complications, highlighting its potential as a viable alternative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation for the treatment of early gastric cancer. Murakami, M., Nishino, K., Inoue, A., et al.[2013]

In a study of 246 patients with large colonic polyps (≥20 mm), the use of argon plasma coagulation (APC) on the EMR edge significantly reduced local adenoma recurrence rates after endoscopic mucosal resection (EMR).

Only 5% of patients had residual tumors at the resection site, suggesting that APC may enhance the effectiveness of EMR in preventing recurrence, although further validation in randomized controlled trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cap-fitted endoscopic mucosal resection of ≥ 20 mm colon flat lesions followed by argon plasma coagulation results in a low adenoma recurrence rate. Raju, GS., Lum, P., Abu-Sbeih, H., et al.[2020]

In a study of 22 patients, argon-plasma coagulation (APC) achieved a high complete ablation rate of 90.9% for flat colorectal adenomas, demonstrating its efficacy as a treatment method.

The procedure was found to be safe, with no major complications reported, although a recurrence rate of 20% was noted, primarily in the rectum, indicating the need for further research to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of argon plasma coagulator ablation therapy for flat colorectal adenomas. García, A., Núñez, O., González-Asanza, C., et al.[2019]

Carbon ion radiotherapy (C-ion RT) demonstrated a high 5-year local control rate of 92% in treating locally advanced adenoid cystic carcinoma (ACC) of the tongue base, indicating its efficacy for this challenging cancer type.

While C-ion RT was effective, it did have some safety concerns, with 2 patients experiencing severe mandible osteoradionecrosis and 1 patient suffering from significant hemorrhage, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and efficacy of carbon ion radiotherapy for locally advanced adenoid cystic carcinoma of the tongue base. Koto, M., Hasegawa, A., Takagi, R., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10135954/

Hybrid Argon Plasma Coagulation for Barrett's Esophagus ... Hybrid argon plasma coagulation (hAPC) is a novel technique that combines conventional argon plasma coagulation and waterjet submucosal expansion.

2. giejournal.org giejournal.org/article/S0016-5107(22)01878-8/fulltext

Hybrid argon plasma coagulation after endoscopic ... These results are excellent and allow hypothesizing that hybrid APC may be the method of choice, potentially because of the safer ablation of deeper tissue.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06271941

NCT06271941 | Reducing Neoplasia Recurrence After ... New techniques for LSL resection (hybrid argon plasma coagulation (h-APC) margin and base ablation) have shown a reduction in recurrence following the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590030721000647

Hybrid APC Colon EMR, A Novel Approach to Reduce ... We examine a novel technique, hybrid APC assisted EMR, which treats both the edge and the base with cautery to assess its effect on local recurrence.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/09150/comparing_efficacy_and_factors_of_postoperative.15.aspx

Comparing efficacy and factors of postoperative bleeding ... This study aimed to assess the effectiveness of Endoscopic Mucosal Resection (EMR) and Argon Plasma Coagulation (APC) as therapeutic approaches for intestinal ...

6. gastrojournal.org gastrojournal.org/article/S0016-5085(11)00274-5/fulltext

Endoscopic Mucosal Resection Outcomes and Prediction ... EMR was effective at completely removing the polyp in a single session in 89.2% of patients; risk factors for lack of efficacy included a prior attempt at EMR ( ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0016510725017225

Safety and efficacy of margin and base ablation after ... EMR is the mainstay of therapy for large colorectal polyps. A previous study has shown low adverse events and recurrence rates after EMR ...

8. mayoclinic.org mayoclinic.org/medical-professionals/digestive-diseases/news/endoscopic-mucosal-resection-for-management-of-large-colorectal-polyps/mac-20442005

Endoscopic mucosal resection for management of large ... Large (greater than 2 cm) colorectal lesions can now be safely and effectively treated endoscopically, most commonly with endoscopic mucosal resection (EMR).

9. gi.org gi.org/journals-publications/ebgi/lee_mar2024/

ESD vs EMR for Large Non-Pedunculated Colon Polyps EMR (either en bloc or piecemeal) is an efficient, safe, and effective approach to remove large, non-pedunculated colorectal polyps.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9132731/

Hybrid argon plasma coagulation-assisted endoscopic ... Background Endoscopic mucosal resection (EMR) of large, sessile colon polyps often results in incomplete resection with subsequent recurrence.