Argon Plasma for Helicobacter Pylori Infection

(HEAPE Trial)

Overseen By Michele B. Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christopher C. Thompson, MD, MSc

Must not be taking: Antibiotics, PPIs

Disqualifiers: Pregnancy, Cardiopulmonary disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking antibiotics or proton pump inhibitors (PPIs) two weeks before the procedure. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment HEAPE, Pre-HEAPE for Helicobacter Pylori Infection?

Research shows that argon plasma coagulation (APC), a component of the treatment, is effective in treating certain gastrointestinal conditions, such as bleeding peptic ulcers and lesions in the upper gastrointestinal tract, which suggests it may have potential benefits for Helicobacter Pylori infection as well. ^{1 2 3 4 5}

How does the Argon Plasma treatment for Helicobacter pylori infection differ from other treatments?

The Argon Plasma treatment, known as HEAPE, is unique because it likely involves a non-drug approach using argon plasma, which is a form of ionized gas, to target Helicobacter pylori infection. This differs from standard treatments that typically use a combination of antibiotics and acid-reducing medications. ^{6 7 8 9 10}

What is the purpose of this trial?

The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible. Two different PAL generation modalities will be compared in this study: 1. HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach. 2. Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope. To evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test. After the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated. This two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.

Research Team

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for individuals with H. pylori infection, which can cause stomach ulcers and other gastrointestinal issues. Participants should be suitable for endoscopic procedures. The study excludes those who may not safely undergo the procedure or have conditions that could interfere with treatment outcomes.

Inclusion Criteria

Confirmed untreated H. pylori infection

I can understand and agree to the study's consent form.

Available to return for all routine follow-up study visits

Exclusion Criteria

Pregnancy or puerperium

Lactation

I have a hernia or am at risk of aspiration.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the HEAPE procedure, where the stomach is filled with sodium chloride solution treated with APC, followed by antibiotic treatment.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for H. pylori eradication using Urea Breath Test and adverse events are recorded.

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• HEAPE
• Pre-HEAPE

Trial Overview The trial tests a new argon plasma-based therapy called HEAPE to treat H. pylori during endoscopy, comparing two methods: direct application in the stomach (HEAPE direct) and pre-treatment outside the body (Pre-HEAPE). It aims to see if this can reduce bacteria levels without thermal damage.

Participant Groups

Group I: Pre-HEAPE Active Control 1 Intervention

This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.

Group II: HEAPE direct Active Control 1 Intervention

This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.

Who Is Running the Clinical Trial?

Christopher C. Thompson, MD, MSc

Lead Sponsor

Trials

6

Recruited

5,300+

Erbe Elektromedizin GmbH

Industry Sponsor

Trials

14

Recruited

840+

Findings from Research

Argon plasma coagulation (APC) therapy has become an important and effective treatment in gastrointestinal endoscopy, with recent studies showing its efficacy in various gastrointestinal disorders.

The complication rates associated with APC are low, indicating it is a well-tolerated option; however, more clinical trials are needed to compare APC with other treatments and assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation therapy. Manner, H.[2014]

The high power argon plasma coagulation system demonstrated safety and efficacy in treating various upper gastrointestinal conditions, with only minor complications occurring in 8.7% of treatment sessions and major complications in just 1.1%.

With a mean of 1.46 treatment sessions required, this system proved to be effective for tumor debulking, suggesting it could serve as a viable alternative to Nd:YAG laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new high power argon plasma coagulation system (hp-APC) in lesions of the upper gastrointestinal tract. Manner, H., May, A., Faerber, M., et al.[2013]

In a study of 41 patients with bleeding peptic ulcers, argon plasma coagulation was found to achieve faster hemostasis compared to the heater probe, with an average time of 60 seconds versus 115 seconds.

Both treatments showed similar rates of initial hemostasis, recurrent bleeding, and 30-day mortality, indicating that argon plasma coagulation is a safe and effective option for managing bleeding peptic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective comparison of argon plasma coagulator and heater probe in the endoscopic treatment of major peptic ulcer bleeding. Cipolletta, L., Bianco, MA., Rotondano, G., et al.[2019]

In a study of 99 patients with solitary rectal ulcer syndrome (SRUS), argon plasma coagulation (APC) significantly improved bleeding control and ulcer healing compared to conventional therapy, with 75.6% response in the APC group versus 29.3% in the control group.

After 3 months, 70.7% of patients treated with APC showed continued healing of ulcers, compared to only 10.3% in the conventional therapy group, indicating that APC is an effective intervention for managing SRUS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of argon plasma coagulation in healing of a solitary rectal ulcer in comparison with conventional therapy: a randomised controlled trial. Zergani, FJ., Shaiesthe, AA., Hajiani, E., et al.[2020]

In a study involving 13 children with significant health issues, argon plasma coagulation was effective in achieving hemostasis in 8 out of 12 cases of bleeding lesions, demonstrating its efficacy in pediatric endoscopy.

The procedure had a low complication rate, with only 17% of patients experiencing minor issues, indicating that argon plasma coagulation is a safe option for managing bleeding and tissue ablation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation: Clinical experience in pediatric patients. Khan, K., Schwarzenberg, SJ., Sharp, H., et al.[2017]

Helicobacter pylori should be tested and eradicated in specific patient groups, including those with a history of ulcers, chronic dyspepsia, and high risk factors for gastric cancer, to prevent complications before starting NSAIDs treatment.

The Urea Breath Test is the most reliable method for diagnosing H. pylori infection, and in areas with high antibiotic resistance, new treatment regimens like sequential therapy or bismuth-containing quadruple therapies are recommended over standard triple therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New recommendations for the diagnosis and the treatment of Helicobacter pylori infection]. de Korwin, JD.[2020]

Helicobacter pylori is linked to various gastric diseases, including chronic gastritis and ulcers, and its eradication can lead to healing and reduced antibody levels in affected patients.

The most effective treatment for H. pylori involves a combination of bismuth salts and two antibiotics, although successful eradication is not guaranteed in all cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helicobacter pylori and associated gastroduodenal diseases. Review article. Rautelin, H., Kosunen, TU.[2006]

Helicobacter pylori (H.p.) eradication is crucial for treating conditions like peptic ulcers and certain types of gastric lymphoma, but it does not improve symptoms of non-ulcer dyspepsia, highlighting the need for targeted treatment based on specific indications.

First-line treatments for H.p. infection typically involve a proton pump inhibitor (PPI) or ranitidine bismuth citrate combined with two antibiotics, with clarithromycin and amoxicillin being the most effective, although resistance to metronidazole is a growing concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of Helicobacter pylori infections]. Hentschel, E.[2020]

Helicobacter pylori is a significant cause of chronic gastritis and is linked to peptic ulcers and gastric cancer, making its detection and eradication crucial for patients with peptic ulcers to improve their condition.

Current treatment regimens for eradicating H. pylori can be simplified; effective options like omeprazole combined with amoxicillin or clarithromycin are better tolerated than traditional triple therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helicobacter pylori. Fennerty, MB.[2006]

The European Helicobacter pylori Study Group recommends using non-invasive tests like the urea breath test (UBT) and antigen stool assay for diagnosing H. pylori in low-risk patients, emphasizing their effectiveness in the 'test and treat strategy'.

For confirming the eradication of H. pylori after treatment, the UBT is preferred, with the stool antigen assay as a backup, highlighting the importance of accurate follow-up testing to ensure successful treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The diagnosis of helicobacter pylori infection: guidelines from the Maastricht 2-2000 Consensus Report]. Pellicano, R., Fagoonee, S., Palestro, G., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation therapy. [2014]

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

Safety and efficacy of a new high power argon plasma coagulation system (hp-APC) in lesions of the upper gastrointestinal tract. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Prospective comparison of argon plasma coagulator and heater probe in the endoscopic treatment of major peptic ulcer bleeding. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of argon plasma coagulation in healing of a solitary rectal ulcer in comparison with conventional therapy: a randomised controlled trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation: Clinical experience in pediatric patients. [2017]

6. France pubmed.ncbi.nlm.nih.gov

[New recommendations for the diagnosis and the treatment of Helicobacter pylori infection]. [2020]

7. Denmark pubmed.ncbi.nlm.nih.gov

Helicobacter pylori and associated gastroduodenal diseases. Review article. [2006]

8. Austria pubmed.ncbi.nlm.nih.gov

[Treatment of Helicobacter pylori infections]. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Helicobacter pylori. [2006]

10. Italy pubmed.ncbi.nlm.nih.gov

[The diagnosis of helicobacter pylori infection: guidelines from the Maastricht 2-2000 Consensus Report]. [2020]