Results after endoscopic removal of colorectal lesions using an advanced energy device
| ISRCTN | ISRCTN15269750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15269750 |
| ClinicalTrials.gov (NCT) | Nil Known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | RN800372 |
| Sponsor | East Kent Hospitals University NHS Foundation Trust |
| Funder | East Kent Hospitals University NHS Foundation Trust |
- Submission date
- 06/03/2023
- Registration date
- 11/03/2023
- Last edited
- 09/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Speedboat-assisted endoscopic submucosal dissection (SSD) is a technique that utilizes a special endoscopic instrument (the Speedboat™) to remove lesions in the colon and rectum in one piece. The performing doctor inserts the Speedboat™ device via the telescope/endoscope during the colonoscopy procedure. At the end of the procedure, the polyp will be removed entirely in one piece, pinned out to a hard board and sent to the lab for an accurate histological/microscopic assessment. This study aims to assess the clinical short- and long-term outcomes of all patients who underwent Speedboat-assisted endoscopic submucosal dissection in East Kent Hospitals University NHS Foundation Trust.
Who can participate?
Patients aged over 18 years with a colon/rectum lesion with a recommendation to use the ESD technique to remove the lesion
What does the study involve?
The collected data will include patients’ medical history, polyps’ characteristics, specific technical details, any complications and short- and long-term outcomes.
What are the possible benefits and risks of participating?
This study will help to find out who will benefit the most from SSD removal of polyps as well as monitor any complications and measure clinical outcomes. Removing these lesions will prevent colorectal cancer. There are no added risks of participating in this study apart from the established and recognised risks of endoscopic en-bloc (one piece) removal of the lesion. This is part of the patient's standard of care.
Where is the study run from?
Queen Elizabeth the Queen Mother Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2018 to January 2024
Who is funding the study?
East Kent University Hospitals NHS Foundation Trust (UK)
Who is the main contact?
1. Zacharias Tsiamoulos, ztsiamoulos@nhs.net
2. Mr Shady Zeidan, s.zeidan@nhs.net
Contact information
Principal investigator
Queen Elizabeth The Queen Mother Hospital
St Peters Road
Margate
CT9 4AN
United Kingdom
| 0000-0003-0235-7110 | |
| Phone | +44 (0)1843225544 |
| ztsiamoulos@nhs.net |
Scientific
William Harvey Hospital
Kennington Rd, Willesborough
Ashford
TN24 0LZ
United Kingdom
| 0000-0002-5153-0437 | |
| Phone | +44 (0)1233 633331 |
| s.zeidan@nhs.net |
Scientific
Queen Elizabeth the Queen Mother Hospital
St Peter's Lane
Margate
CT4 9AN
United Kingdom
| Phone | +44 (0)1843225544 |
|---|---|
| muneer.abbas@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort audit |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Speedboat-assisted endoscopic submucosal dissection - clinical outcomes |
| Study acronym | SSD Clinical Outcomes |
| Study objectives | Speedboat™ Inject device is a CE-marked endo-surgical device that allows safe tissue cutting and coagulation in the gastrointestinal (GI) tract. Using special electrocautery properties (Bipolar Radiofrequency), tiny cuts underneath the polyp surface are made to separate it from the bowel wall. Any blood vessels that feed the polyp are sealed using a different type of coagulation (high-frequency microwave). It facilitates a swift Endoscopic Submucosal Dissection (ESD) with a small risk of bleeding or perforation. |
| Ethics approval(s) | Approved 11/03/2022, the audit department at East Kent University Hospitals NHS Foundation Trust (Clinical Audit Office, Kent and Canterbury Hospital, Ethelbert Road, Canterbury, Kent, CT1 3NG, UK; +44 (0)1227 864300 ext 722 2010; ekh-tr.ClinicalAudit@nhs.net), ref: RN800372 |
| Health condition(s) or problem(s) studied | Consecutive patients with colorectal polyps referred from the complex polyp multi-disciplinary meeting to remove polyps and prevent bowel cancer |
| Intervention | Endoscopic treatment with submucosal dissection of colorectal polyps. A prospective cohort of colorectal Speedboat-assisted Submucosal Dissection (SSD) cases is initiated for a duration of 6 years, lined up with STROBE guidelines. One experienced operator will perform all cases. Short and long-term clinical outcomes are recorded. Simple and multiple linear regression statistical analysis will be used to explore whether factors, such as polyp size/surface/location/morphology could impact the duration of the procedure. Cost analysis from the hospital perspective will be also conducted. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Rate of complete resection: measuring the number of polyps (percentage) that were completely removed en-bloc (in one piece) to the total number of polyps removed. The rate is compared to the standard benchmark rate of >90%. |
| Key secondary outcome measure(s) |
1. Polyp size/surface/location/morphology as documented on the endoscopy report on the day of the procedure from Unisoft/Solus. From 01/01/2018 till 01/10/2024 |
| Completion date | 01/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Aged >18 years old 2. Lower GI lesion - colon and rectum 3. Lesion of any size and any pathology 4. Discussed in the complex polyp multi-disciplinary with a recommendation to use the ESD technique to remove the lesion 5. Speedboat-assisted ESD technique to be used to remove the lesion |
| Key exclusion criteria | 1. Age <18 years 2. Pregnancy 3. Upper GI lesion - oesophagus, stomach, duodenum and small bowel 4. Lesions removed by other techniques (i.e. not by ESD) as planned by the complex polyp multi-disciplinary meeting 5. Lesions not discussed at the complex polyp multi-disciplinary meeting |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 01/01/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Margate
CT9 4AN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| IPD sharing plan | Data will be stored on East Kent Hospitals University NHS Foundation Trust (EKHUFT)'s secured computer which is not publicly available. This data has patient confidential data and therefore it will remain saved in a trusted shared drive within the EKHUFT IT system. The dataset will not be made available to protect patients' confidentiality unless the audit department in EKHUFT provides authorisation if the data is required to be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 07/03/2023 | No | No |
Additional files
- 43322_PROTOCOL.pdf
- Protocol file
Editorial Notes
07/03/2023: Trial's existence confirmed by East Kent Hospitals University NHS Foundation Trust (EKHUFT).