Double Thermal Ablation for Colon Polyps

(ABLATION Trial)

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

Trial Summary

What is the purpose of this trial?

Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. New techniques for LSL resection (hybrid argon plasma coagulation (h-APC) margin and base ablation) have shown a reduction in recurrence following the interventions. We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation during EMR of large (≥20mm) colorectal LSLs will lead to lower rates of lesion recurrence compared to Snare tip soft coagulation (STSC) margin ablation.

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 data supports the effectiveness of the treatment Double Thermal Ablation for Colon Polyps?

Research shows that argon plasma coagulation (APC), a component of the treatment, is effective and safe for treating various types of colon polyps, including flat colorectal adenomas and polyp remnants. Additionally, both snare tip soft coagulation (STSC) and APC have been used to reduce recurrence rates after polyp removal, indicating their effectiveness in managing colon polyps. ^{1 2 3 4 5}

Is Double Thermal Ablation for Colon Polyps safe for humans?

Argon plasma coagulation (APC), a component of Double Thermal Ablation, has been used safely in treating colon polyps and other gastrointestinal conditions. Studies have shown that both APC and snare tip soft coagulation (STSC) are generally safe for use in humans, with no significant safety concerns reported. ^{2 3 4 5 6}

How does the Double Thermal Ablation treatment for colon polyps differ from other treatments?

Double Thermal Ablation for colon polyps is unique because it likely involves a combination of thermal techniques, such as argon plasma coagulation (APC), which is a noncontact method that uses heat to treat tissue. This approach may offer a novel way to manage polyps by potentially reducing recurrence rates compared to traditional methods. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Hyperplastic polyps after surgical management of Hirschsprung's disease in children treated with argon plasma coagulation: Case report. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy and safety of argon plasma coagulation (APC) in the management of polyp remnants in stomach and colon. [2013]

3. Spain pubmed.ncbi.nlm.nih.gov

Safety and efficacy of argon plasma coagulator ablation therapy for flat colorectal adenomas. [2019]

4. United States 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. [2023]

5. United States 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. [2014]

6. Germany pubmed.ncbi.nlm.nih.gov

Spray coagulation with snare-tip versus argon plasma coagulation: An ex vivo study evaluating tissue effects. [2021]