Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06317727 |
| Other study ID # |
IRAS 337105 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
May 2030 |
Study information
| Verified date |
March 2024 |
| Source |
King's College Hospital NHS Trust |
| Contact |
Ademola A Adeyeye, MBBS,MSc,FRCS,FEBS, FMAS, PGDE |
| Phone |
02032993210 |
| Email |
ademola.adeyeye1[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is to learn about the role of electroporation (the use
of small electric pulses applied to tissue) in the treatment (ablation) of colorectal polyps.
The main questions to answer in this pilot phase of the study are:
1. The safety of pulsed field ablation (PFA) for the removal of colorectal polyps
2. The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics
such as treatment coverage, treatment time, post treatment fibrosis, post treatment
recurrence and patient satisfaction
Description:
Colorectal cancer is the commonest cancer of the digestive tract, the second commonest cause
of cancer deaths in the western hemisphere and the third commonest cancer in the United
Kingdom. Most bowel cancers arise from precancerous growths called polyps. Prompt and
effective treatment of these polyps can potentially prevent or cure bowel cancer at its
earliest stages. King's College Hospital runs a special service dedicated to treating these
lesions called the Special Polyps and Early Colorectal Cancer Service (SPECCS) using a
variety of methods. These techniques usually involve removing the polyps through endoscopic
resection. Other options include laparoscopic surgery, robotic surgery and rarely, open
surgery. These modalities of treatments come with a number of risks, are highly invasive,
require extensive skill and also have a long waiting list.
Endoscopic ablation with electroporation offers the potential of treating colorectal polyps
in an easier, faster and less invasive manner. Electroporation uses small, high frequency,
electric pulses, applied on the surface of tissues to temporarily open up pores in the outer
wall of these cells. These pores, disrupts the structure of the abnormal cells and cause cell
death via apoptosis. This approach has been used to treat frail patients with advanced
colored cancer who cannot undergo more aggressive forms of treatment and it is postulated
that this technology also has the ability to deal with colorectal polyps. This study is a
pilot research involving a small number of patients with colorectal polyps who will be
treated with electroporation given during colonoscopy.
Patients who participate in this study will be treated using endoscopic electroporation with
the intent of ablating NICE (Narrow Band Imaging International Colorectal Endoscopic
classification) Type 1 or Type 2 colorectal polyps. The treatment will typically be carried
out under sedation. Small risks for this procedure include complications such as bleeding,
intestinal perforation, infection and an adverse reaction to the anaesthetic medication.
Patients who have been treated with electroporation have also reported the following symptoms
following treatment: pyrexia, obstipation, diarrhea, pyrexia, nausea, headaches, and joint
pain. Patients will be required to return for the first follow-up visit, approximately 6
weeks after the initial treatment, at which time they will need to have a colonoscopy. If
there is evidence that the initial treatment has not removed 100% of the polyp, an additional
treatment will be offered, or the polyp will be removed by Endoscopic Mucosal Resection (EMR)
which is the standard treatment for this indication. This decision will be taken by the
patient's primary physician. Patients who have an additional treatment will return
approximately 12 weeks after the initial treatment for another colonoscopy that falls outside
of standard of care protocol. All other visits fall under the standard care timelines.
Patients who have successfully been treated with endoscopic ablation will undergo a biopsy at
either the first, or second follow up visit to exclude residual disease. This will be
performed when the patient is under sedation
Clinical review and colonoscopy will be repeated at 6weeks, 6months and 5years from initial
contact to assess the effectiveness on the polyp and the safety of the patient
