Endoscopic Knives for Gastrointestinal Cancer

Not currently recruiting at 1 trial location

Overseen By Michael Mercado

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Under 18, Pregnant, Others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two tools used in endoscopic submucosal dissection (ESD), a procedure for treating gastrointestinal cancer. Researchers aim to determine if a new knife, the bipolar RFA knife (radiofrequency ablation knife), outperforms the traditional monopolar current cutting knife. The trial is open to individuals referred for an ESD procedure to remove cancerous growths in the digestive tract. Participants will help identify which knife provides better patient outcomes. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these endoscopic knives are safe for gastrointestinal cancer procedures?

Research has shown that the bipolar knife used in endoscopic procedures is generally safe for people. One study found that this tool can make surgeries quicker and may cause fewer side effects compared to the monopolar knife, suggesting it is well-tolerated by patients.

For the monopolar knife, evidence indicates it performs similarly to the bipolar knife in terms of wound size and cutting speed. However, some research suggests it might lead to more side effects than the bipolar knife.

Overall, both knives have undergone testing in human studies, and the data suggests they are safe. However, the bipolar knife might have a slight advantage in causing fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new endoscopic knives for gastrointestinal cancer treatment because they offer distinct advantages over traditional options. The Bipolar RFA Knife introduces a novel mechanism by using radiofrequency energy, which may provide more precise cutting and reduce bleeding during procedures. On the other hand, the Monopolar Current Cutting Knife, while similar to current options, continues to be a reliable choice for comparison in assessing the benefits of the bipolar approach. These innovations could lead to safer and more effective endoscopic procedures, potentially improving patient outcomes significantly.

What evidence suggests that this trial's treatments could be effective for gastrointestinal cancer?

In this trial, participants will undergo procedures using either the Bipolar Knife or the Monopolar Knife. Research has shown that the new Bipolar Knife is promising for treating digestive system issues, performing as well as the Monopolar Knife in tissue removal. Studies have demonstrated its success in cutting and removing targeted tissue. The Bipolar Knife has also undergone testing for safety and efficiency in procedures like removing cancerous tissues from the esophagus. For the Monopolar Knife, research indicates it matches the Bipolar Knife in cutting speed and wound size. Overall, both knives have proven effective in removing cancerous tissues from the digestive tract. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need an endoscopic submucosal dissection (ESD) procedure for gastrointestinal tumors. They must be able to give informed consent. It's not open to those with lesions removed by other methods, under 18s, those unable to consent, or pregnant women.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I am referred for a procedure to remove a growth in my digestive tract.

Exclusion Criteria

Patient is a pregnant woman

Patient refused and/or unable to provide consent

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic submucosal dissection (ESD) using either a monopolar or bipolar knife

1 day

1 visit (in-person)

Immediate Post-procedural Monitoring

Participants are monitored for immediate adverse events such as abdominal pain

Up to 24 hours

Follow-up

Participants are monitored for delayed post-procedural adverse events, including post polypectomy syndrome

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bipolar RFA Knife
• Monopolar Current Cutting Knife

Trial Overview The study compares the effectiveness of a new Bipolar Knife versus traditional Monopolar Knives in ESD procedures at Baylor St. Luke's Medical Center. Patients are randomly assigned one of the two surgical tools to see which performs better.

How Is the Trial Designed?

Group I: Bipolar Knife Experimental Treatment 2 Interventions

ESD procedure performed with a novel bipolar knife.

Group II: Monopolar Knife Active Control 2 Interventions

ESD procedure performed with monopolar knives.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9722839/

An advanced bipolar device helps reduce the rate ... We compared the efficacy and safety of ABD and USAD in laparoscopic gastrectomy for gastric cancer patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06476678

Novel Bipolar Radiofrequency Ablation Knife in ... The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device. Detailed ...

3. journals.lww.com journals.lww.com/ajg/fulltext/2023/10001/s1211_similar_efficacy_of_a_novel_bipolar.2029.aspx

S1211 Similar Efficacy of a Novel Bipolar Radiofrequency... The primary outcome was successful completion of dissection with the intended knife and technical success (en bloc/R0 resection rates). Secondary endpoints ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19279436/

Endoscopic radiofrequency ablation in colorectal cancer This paper reports our initial assessment of a new bipolar radiofrequency probe (Endoblate). Methods: Twelve patients with rectosigmoid tumors were treated with ...

5. journalslibrary.nihr.ac.uk journalslibrary.nihr.ac.uk/hta/YYMN9802

Clinical and cost effectiveness of endoscopic bipolar ... To assess the clinical effectiveness, cost-effectiveness and potential risks of endoscopic bipolar radiofrequency ablation for malignant biliary obstruction.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04919824

Monopolar Current Cutting Knife vs Bipolar RFA ... This is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of a novel Bipolar Knife vs. Monopolar Knives on patients who ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10352061/

Long-term Outcomes of Endoscopic Intraductal ... Endoscopic ID-RFA showed good long-term outcomes in treating residual or relapsed ampullary adenomas with intraductal extension.