Gastrointestinal HaemorrhageNCT02833558
Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection
A study testing PuraStat® and Electrocautery in people with Gastrointestinal Haemorrhage, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered problem during submucosal dissection and is usually managed with electrocautery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Haemorrhage
- What is being tested?
- PuraStat® and Electrocautery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2016to 18 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female, aged 18 years or above.
- An ESD is attempted for clinical indications approved by MDT.
- Oesophageal or colonic lesion 2-5cm in size
- Participant is willing and able to give informed consent for participation in the study
Who cannot join
- Known coagulopathy likely to affect risk of bleeding
- Submucosal tumour
- Anticoagulation or anti-platelet therapy (apart from single modality aspirin or clopidogrel) which cannot be stopped for clinical reasons
- Patient preference
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmputh Hospitals NHS Trust
Portsmouth, PO6 3LY
About this study
Official title: Randomised Controlled Trial Comparing Purastat® to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered problem during submucosal dissection and is usually managed with electrocautery. However, this does carry a risk of deep thermal injury and perforation.
PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent adherent barrier when applied to a bleeding point.
The aim of this trial is to study the use of PuraStat® in reducing the need for thermal haemostasis during ESD.
Read the detailed description
Endoscopic submucosal dissection (ESD) is an endoscopic technique that involves the use of an endoscopic knife to gently peel off a superficial neoplasia of any size in an en-bloc fashion. It meets the principles of onco-surgery and is associated with excellent outcomes. A difficulty however with the technique is control of bleeding during the procedure. The GI mucosa is a vascular territory and the current method of managing intraprocedural bleeding is electrocautery using either the endoscopic knife itself or the coag grasper. This introduces a thermal injury to the bowel wall and carries the risk of causing a perforation or causing pain. Furthermore, it requires precise targeting of the bleeding vessel. Practically this can be challenging, particularly if the coag grasper is needed which is a bulky device and can be difficult to apply precisely in some locations.
PuraStat® (3-D Matrix Ltd, Tokyo) is a liquid which is applied to a bleeding area which acts rapidly to form a gel coat which induces haemostasis. This transparent adherent barrier permits further endoscopic therapy to be performed. It can be applied in the general area of bleeding and does not require precise application to the exact point of bleeding. It is applied through a small catheter placed through the biopsy channel of the endoscope which can be used in very small spaces.
PuraStat® is licensed as a CE marked device for use in exudative haemorrhage from vessels in solid organs and within the GI tract. Given this indication, the role of PuraStat in ESD needs to be explored as it could reduce the need for thermal haemostasis. This would be of significant clinical benefit during ESD.
- Conditions
- Gastrointestinal Haemorrhage
- Being tested
- PuraStat®, Electrocautery
- Keywords
- Endoscopy, Gastrointestinal, Endoscopic Submucosal Dissection, Bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuraStat®Device
PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point
ElectrocauteryProcedure or surgery
Electrocautery (coagulation current) to stop bleeding during ESD
| Study group | Role | What they receive |
|---|---|---|
| PuraStat® | Experimental | Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to stop bleeding during ESD. Receives: Device: PuraStat® |
| Standard Electrocautery | Other | Control arm where standard electrocautery delivered via the endoscopic knife tip or coag grasper is used to achieve haemostasis during ESD Receives: Procedure: Electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of times intraprocedural heat therapy is used to achieve haemostasis in ESD in both the PuraStat® and control arms of the study
Measured: Measured during the ESD procedure
Secondary outcomes (4)
The length of the procedure in the PuraStat® and control arm of the study
Measured: Measured during the ESD procedure
The number of patients with delayed bleeding (bleeding within 28 days) in both the PuraStat® and control arm of the study
Measured: 28 days
Wound healing in the PuraStat® and control arm at 6 weeks post ESD
Wound healing will be measured at endoscopy using qualitative descriptor categories (active ulceration, healing ulceration, scarring or complete mucosal healing). There is no standard definition to qualify ulcer healing post ESD but these categories have previously been used by Uraoka et al in a similar study published in Gastrointestinal Endoscopy (Vol 83, No 6:2016.1259-1264).
Measured: 6 weeks
Number of adverse events in the PuraStat® and control arm of the study
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start4 May 2016
- Primary completion12 Apr 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, MBBS, MD, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833558
- Sponsor's protocol ID
- PHT/2015/106
- Status last verified
- Jun 2018
- First submitted
- 29 Jun 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing Purastat® to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT02833558
- Acronym / sponsor ID
- PHT/2015/106
- Conditions
- Gastrointestinal Haemorrhage
- Keywords
- Endoscopy, Gastrointestinal, Endoscopic Submucosal Dissection, Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 4 May 2016 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered problem during submucosal dissection and is usually managed with electrocautery. However, this does carry a risk of deep thermal injury and perforation.
PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent adherent barrier when applied to a bleeding point.
The aim of this trial is to study the use of PuraStat® in reducing the need for thermal haemostasis during ESD.
Detailed description
Endoscopic submucosal dissection (ESD) is an endoscopic technique that involves the use of an endoscopic knife to gently peel off a superficial neoplasia of any size in an en-bloc fashion. It meets the principles of onco-surgery and is associated with excellent outcomes. A difficulty however with the technique is control of bleeding during the procedure. The GI mucosa is a vascular territory and the current method of managing intraprocedural bleeding is electrocautery using either the endoscopic knife itself or the coag grasper. This introduces a thermal injury to the bowel wall and carries the risk of causing a perforation or causing pain. Furthermore, it requires precise targeting of the bleeding vessel. Practically this can be challenging, particularly if the coag grasper is needed which is a bulky device and can be difficult to apply precisely in some locations.
PuraStat® (3-D Matrix Ltd, Tokyo) is a liquid which is applied to a bleeding area which acts rapidly to form a gel coat which induces haemostasis. This transparent adherent barrier permits further endoscopic therapy to be performed. It can be applied in the general area of bleeding and does not require precise application to the exact point of bleeding. It is applied through a small catheter placed through the biopsy channel of the endoscope which can be used in very small spaces.
PuraStat® is licensed as a CE marked device for use in exudative haemorrhage from vessels in solid organs and within the GI tract. Given this indication, the role of PuraStat in ESD needs to be explored as it could reduce the need for thermal haemostasis. This would be of significant clinical benefit during ESD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PuraStat® | Experimental | Device: PuraStat®Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to stop bleeding during ESD. |
| Standard Electrocautery | Other | Procedure: ElectrocauteryControl arm where standard electrocautery delivered via the endoscopic knife tip or coag grasper is used to achieve haemostasis during ESD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female, aged 18 years or above.
- An ESD is attempted for clinical indications approved by MDT.
- Oesophageal or colonic lesion 2-5cm in size
- Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (4 listed)
- Known coagulopathy likely to affect risk of bleeding
- Submucosal tumour
- Anticoagulation or anti-platelet therapy (apart from single modality aspirin or clopidogrel) which cannot be stopped for clinical reasons
- Patient preference
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PuraStat®PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point | Device | PuraStat® |
| ElectrocauteryElectrocautery (coagulation current) to stop bleeding during ESD | Procedure or surgery | Standard Electrocautery |
Primary outcome
The number of times intraprocedural heat therapy is used to achieve haemostasis in ESD in both the PuraStat® and control arms of the study
Time frame: Measured during the ESD procedure
4 secondary outcomes
The length of the procedure in the PuraStat® and control arm of the study
Time frame: Measured during the ESD procedure
The number of patients with delayed bleeding (bleeding within 28 days) in both the PuraStat® and control arm of the study
Time frame: 28 days
Wound healing in the PuraStat® and control arm at 6 weeks post ESD
Time frame: 6 weeks
Number of adverse events in the PuraStat® and control arm of the study
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Bhandari, MBBS, MD principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PuraStat® and Electrocautery in people with Gastrointestinal Haemorrhage, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of times intraprocedural heat therapy is used to achieve haemostasis in ESD in both the PuraStat® and control arms of the study (time frame: Measured during the ESD procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.