Double Thermal Ablation for Colon Polyps

(ABLATION Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Inflammatory bowel disease, Poor health, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

892 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to reduce the recurrence of colorectal polyps after removal, focusing on large polyps that can lead to colorectal cancer if not fully removed. Researchers compare two techniques: hybrid argon plasma coagulation (h-APC), which uses a gas to treat tissue, and snare tip soft coagulation (STSC), which uses heat. Participants should be adults undergoing removal of large polyps during a planned colonoscopy. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance future colorectal cancer prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these techniques are safe for removing large colorectal polyps?

Research has shown that hybrid argon plasma coagulation (h-APC) is generally safe for removing large colon polyps. One study found no cases of polyps returning after 6 months, and the procedure was well-tolerated with no major safety concerns. Another study confirmed these results, noting few side effects with this method.

For snare tip soft coagulation (STSC), research also suggests safety. In one study, 10.3% of patients experienced bleeding during the procedure, 6.5% had delayed bleeding, and 2% faced the risk of perforation (a hole or tear in the colon). While these issues can occur, they are relatively uncommon.

Overall, both treatments are considered well-tolerated with manageable risks, making them promising options for polyp removal in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Double Thermal Ablation approach for colon polyps because it combines advanced techniques to potentially improve treatment outcomes. Hybrid Argon Plasma Coagulation (h-APC) offers a unique method of ablating tissue margins and bases with precision, which could enhance the thoroughness of polyp removal compared to traditional methods. Meanwhile, Snare tip soft coagulation (STSC) utilizes the snare tip for targeted coagulation, which might reduce the risk of damaging surrounding tissues. Both techniques aim to minimize recurrence and improve safety, which is why they are generating interest as potential enhancements to the standard Endoscopic Mucosal Resection (EMR) procedure.

What evidence suggests that this trial's treatments could be effective for reducing lesion recurrence in large colorectal polyps?

This trial will compare two treatment approaches for colon polyps. Research has shown that hybrid argon plasma coagulation (h-APC), which participants in one arm of this trial may receive, is promising in reducing the recurrence of large colorectal polyps. Early studies found a 0% local recurrence rate at 6 months after using h-APC, suggesting it might safely and effectively remove deeper tissue. In contrast, snare tip soft coagulation (STSC), which participants in another arm of this trial may receive, is known to be safe and effective, reducing the chance of polyp recurrence. One study showed that 4.6% of polyps treated with STSC had some remaining at follow-up, compared to 21.4% without any treatment at the edges. Both treatments have proven effective, but h-APC may better prevent polyps from returning. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having a specific type of colonoscopy to remove large colorectal polyps. They must be in good health, not have inflammatory bowel disease or blood clotting problems, and can't have cancerous or pedunculated polyps.

Inclusion Criteria

Patients providing written and informed consent for study participation

I am having a procedure to remove a large growth in my colon.

Exclusion Criteria

Coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 10^9/L)

I am scheduled for an urgent colonoscopy.

My biopsy shows cancer in a polyp.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endoscopic Mucosal Resection (EMR) with either h-APC or STSC margin ablation

1 day

1 visit (in-person)

Initial Follow-up

Telephone calls to assess possible adverse events within the first 14 days after EMR

2 weeks

1 call (virtual)

Follow-up 1

Surveillance colonoscopy for assessment of recurrence 6 months after EMR

6 months

1 visit (in-person)

Follow-up 2

Surveillance colonoscopy for assessment of recurrence 18 months after EMR

18 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hybrid Argon Plasma Coagulation (h-APC)
• Snare tip soft coagulation (STSC)

Trial Overview The study compares two techniques after removing large colorectal polyps: h-APC (a kind of electric coagulation) versus STSC (another coagulation method). It also looks at whether sealing the removal site affects recovery.

How Is the Trial Designed?

Group I: Endoscopic Mucosal Resection (EMR)+Hybrid Argon Plasma Coagulation (h-APC) Experimental Treatment 1 Intervention

Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin and base of the polypectomy site will be performed using Hybrid Argon Plasma Coagulation (h-APC, Erbe Hybrid APC).

Group II: Endoscopic Mucosal Resection (EMR) + Snare tip soft coagulation (STSC) Active Control 1 Intervention

Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin of the polypectomy site will be performed using Snare tip soft coagulation (STSC).

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Argon plasma coagulation (APC) is an effective and safe method for destroying polyp remnants after endoscopic polypectomy, achieving effective destruction in 90.9% of gastric polyps and 96.4% of colonic polyps in a study of 47 patients.

The study found that higher electric power and multiple APC sessions are crucial for effectively removing remnants, especially for larger gastric polyps in specific locations and those with adenomatous content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of argon plasma coagulation (APC) in the management of polyp remnants in stomach and colon. Neneman, B., Gasiorowska, A., Małecka-Panas, E.[2013]

In a study involving 3 explanted porcine esophagi and 8 pigs, precise argon plasma coagulation (APC) caused significantly less thermal damage to the tunica muscularis compared to pulsed APC, suggesting it may be safer for delicate tissues.

The research identified two types of tissue damage from APC: a common superficial injury (type A) and a new deeper injury pattern (type B), highlighting the need for careful application to minimize harm, especially in sensitive areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the thermal tissue effects of the argon plasma coagulation modes "pulsed" and "precise" on the porcine esophagus, ex vivo and in vivo. Kähler, GF., Szyrach, MN., Hieronymus, A., et al.[2014]

Snare-tip spray coagulation (SC) at 60W and 80W demonstrated comparable coagulation depths and area effects to argon plasma coagulation (APC) at 40W, suggesting SC could be a safe and effective alternative for gastrointestinal procedures.

The study found that SC60 and SC80 reached deeper tissue layers (muscularis mucosa) more frequently than APC20, indicating that SC may provide effective hemostasis and ablation similar to APC while potentially being more cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spray coagulation with snare-tip versus argon plasma coagulation: An ex vivo study evaluating tissue effects. Fetz, A., Farnell, D., Irani, S., et al.[2021]

Argon plasma coagulation is an effective and safe technique for the endoscopic management of hyperplastic polyps in the gastrointestinal tract, as demonstrated in a case involving a 3-year-old girl with rectal bleeding.

In this case, the technique successfully ablated sessile polyps after previous endoscopic removal of pedunculated polyps, indicating its potential for treating similar conditions, though further clinical trials are needed for comprehensive evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperplastic polyps after surgical management of Hirschsprung's disease in children treated with argon plasma coagulation: Case report. Ibrahim, R., Mahmoud, J., Sandouk, F.[2022]

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]

In a randomized trial involving 384 patients, snare tip soft coagulation (STSC) and argon plasma coagulation (APC) both significantly reduced the recurrence of residual lesions after endoscopic mucosal resection (EMR) compared to no treatment, with STSC showing a lower rate of residual polyps (4.6%) compared to APC (9.3%) and control (21.4%).

STSC was not only effective but also quicker to apply than APC (3.35 minutes vs 4.08 minutes), making it a more efficient and cost-effective option for thermal margin treatment after colorectal EMR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial. Rex, DK., Haber, GB., Khashab, M., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34905795/

Hybrid argon plasma coagulation-assisted ... - PubMed These preliminary results showed 0 % local recurrence rate at 6 months and demonstrated the safety profile of hAPC-EMR. A large, randomized, controlled ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510722017692

EMR combined with hybrid argon plasma coagulation to ... The primary study outcome was recurrence rates found during the first follow-up colonoscopy. Secondary outcomes were technical success and adverse event rates.

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. 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.

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

Hybrid argon plasma coagulation-assisted endoscopic ... This was a prospective, single-center, pilot study assessing the recurrence rate and safety of hAPC-EMR for the removal of large sessile colonic polyps. The ...

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. giejournal.org giejournal.org/article/S0016-5107(22)01769-2/abstract

EMR combined with hybrid argon plasma coagulation to ... The primary study outcome was recurrence rates found during the first follow-up colonoscopy. Secondary outcomes were technical success and ...