Colorectal endoscopic mucosal resection (a procedure to remove precancerous, early-stage cancer or other abnormal tissues from the digestive tract) and reducing delayed bleeding in high risk patients
| ISRCTN | ISRCTN14491102 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14491102 |
| IRAS number | 281764 |
| Secondary identifying numbers | CPMS 50081, IRAS 281764 |
- Submission date
- 03/12/2021
- Registration date
- 19/01/2023
- Last edited
- 11/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Delayed bleeding (bleeding from the bowel occurring more than 24 hours following endoscopic removal of polyps) is the most common complication following Endoscopic Mucosal Resection (EMR), occurring in up to 12% of cases depending on various risk factors. To date, there are no established guidelines to lessen this risk, with various studies of different treatment options showing some inconsistent and sometimes conflicting results. PuraStat® is a licenced product that can be applied through the endoscope directly following polyp removal to form a gel coat over the area where the polyp was removed. This product is already in use in UK hospitals in endoscopy procedures and has been proven to be completely safe.
The aim of the study is to collect data to help us understand whether applying PuraStat® after a colorectal polyp is removed can reduce the risk of delayed bleeding for a period of 30 days following EMR, compared to not using PuraStat® (standard practice).
Who can participate?
Patients undergoing EMR of colorectal polyps, and with high risk of delayed bleeding.
What does the study involve?
Patients with high delayed bleeding risk referred for EMR of colorectal polyps of 20mm or more in size will be randomised to receive either prophylactic application of PuraStat® to the EMR base (treatment group) or standard treatment (no PuraStat®, control group).
What are the possible benefits and risks of participating?
Whilst no financial reward can be made for taking part in the study, the information collected will be valuable to inform future practice.
There are no additional risks to taking part in the study as the risks of the procedure are not altered in the study.
Where is the study run from?
The study is Sponsored by Portsmouth Hospitals University NHS Trust (UK)
When is the study starting and how long is it expected to run for?
September 2021 to December 2024
Who is funding the study?
3-D Matrix UK Ltd.
Who is the main contact?
Prof Pradeep Bhandari (Chief Investigator), pradeep.bhandari@porthosp.nhs.uk
Contact information
Principal Investigator
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)2392 286000 ext.1207 |
|---|---|
| pradeep.bhandari@porthosp.nhs.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Colorectal endoscopic mucosal resection and delayed bleeding: a prospective multicentre randomized controlled superiority trial comparing PuraStat® with conventional practice to reduce the risk of delayed bleeding after colorectal endoscopic mucosal resection in high-risk patients |
| Study acronym | COLOSTAT |
| Study objectives | Use of a haemostatic gel (Purastat®) can reduce the risk of delayed bleeding after colorectal EMR in high-risk patients. |
| Ethics approval(s) | Approved 13/09/2021, London - Bloomsbury Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048285; bloomsbury.rec@hra.nhs.uk), ref: 12/LO/0568 |
| Health condition(s) or problem(s) studied | Colorectal polyps |
| Intervention | Study participants will be randomised to receive either prophylactic application of PuraStat® to the EMR base (treatment group) or standard treatment (no PuraStat®, control group). Intraprocedural bleeding will be dealt with as per standard practice. All equipment needed to deliver thermal therapy will be ready during the entirety of the procedure thereby ensuring no delay in administration should it need to be used. Patient safety and care remains paramount and will not be compromised in this situation. All therapeutic procedures will be performed by endoscopists with expertise in advanced assessment and resection of GI neoplasia. The endoscopes and all other devices used, including snares, will not be different from those routinely used, and are all CE approved. After randomisation, the EMR resection technique will not be different from the standard technique. Bowel preparation will be administered in line with the usual departmental guidelines. All patients will have telephonic follow up at 1-7 days and then at 30 days (+/- 14 days) following the EMR procedure. Patients will be advised on how to seek medical help and how to notify the research team if bleeding occurred in the community. Delayed bleeding will be treated according to routine clinical practice. All these patients will have endoscopic follow up as per routine clinical practice (i.e. at 3-6 months, and at 12 months following EMR). Sample size: 270 patients per group for a total of 540 subjects. After 75% of the planned subjects have been treated and completed the primary efficacy endpoint evaluation a single interim analysis will occur, during which the sample size may increase, but to no more than double the original sample size (540 per group, 1080 subjects) Follow up duration is 30 days (+/- 14 days) Planned study period is 2 years Intervention is PuraStat® applied prophylactically to EMR base. Control is Standard treatment with no PuraStat® |
| Intervention type | Other |
| Primary outcome measure | Delayed bleeding rate. Delayed bleeding is defined as bleeding after 24 hours but within 28 days of the procedure, which can be directly attributed to the EMR, resulting in hospital admission, significant HB drop (≥2 points), haemodynamic compromise, and/or need for endoscopic, radiological or surgical intervention or blood transfusion. |
| Secondary outcome measures | 1. Rate of post polypectomy syndrome post EMR (pain, discomfort, fever, raised inflammatory markers) measured using standard pain scale, thermometer and blood tests at within 28 days post EMR 2. Amount of PuraStat® used (in MLS) measured using Purastat® syringe at time of Purastat® application during EMR procedure 3. Duration of time (in seconds) required to apply PuraStat® measured using a stop watch at time of Purastat® application during EMR procedure |
| Overall study start date | 13/09/2021 |
| Completion date | 08/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 540; UK Sample Size: 440 |
| Key inclusion criteria | 1. Adult (aged 18 years or above at time of recruitment) patients referred for EMR of colorectal polyps 2. Polyp size: 20 mm or more 3. Polyp location: 3.1. Proximal colon: All non-pedunculated polyps ≥20 mm 3.2. Distal colon: All non-pedunculated polyps ≥20 mm and patient is on antiplatelet and/or anticoagulation 4. Participant is willing and able to give informed consent for participation in the study |
| Key exclusion criteria | 1. Adenoma with known (histologically confirmed) carcinoma 2. Coagulopathy (INR ≥1.5, platelets <50) 3. Poor bowel preparation 4. Patients who, according to Investigator’s opinion, should not be included in the study for any reason, including inability to follow study procedures, e.g. cognitively impaired, debilitated or frail patients |
| Date of first enrolment | 09/12/2021 |
| Date of final enrolment | 08/06/2023 |
Locations
Countries of recruitment
- England
- Italy
- Spain
- United Kingdom
Study participating centres
Cosham
Portsmouth
PO6 3LY
United Kingdom
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
Nottingham
NG7 2UH
United Kingdom
112 St. Marks Road
Maidenhead
SL6 6DU
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Fitzrovia
London
NW1 2BU
United Kingdom
London
SW17 0RE
United Kingdom
-
Italy
-
Spain
-
Spain
Sponsor information
Hospital/treatment centre
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
| Phone | +44 2392286000 ext.6236 |
|---|---|
| research.office@porthosp.nhs.uk | |
| Website | http://www.porthosp.nhs.uk/ |
"ROR" |
https://ror.org/009fk3b63 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The analysis of the data will be presented at national and international conferences, including the British Society of Gastroenterology annual general meeting, Digestive Diseases week (USA) and UEGW week (Europe), and ESGE days (Europe). Results will subsequently be published in peer reviewed scientific journals. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
11/02/2024: The following changes were made:
1. The overall study end date was changed from 08/12/2023 to 08/12/2024.
2. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
03/12/2021: Trial's existence confirmed by the NIHR.
