Clinical trial NCT02833558: Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection
Official title: Randomised Controlled Trial Comparing Purastat® to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Haemorrhage
Keywords: Endoscopy, Gastrointestinal
Endoscopic Submucosal Dissection
Bleeding
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: Measured during the ESD procedure
Secondary outcomes:
measure: The length of the procedure in the PuraStat® and control arm of the study
timeFrame: Measured during the ESD procedure
measure: The number of patients with delayed bleeding (bleeding within 28 days) in both the PuraStat® and control arm of the study
timeFrame: 28 days
measure: Wound healing in the PuraStat® and control arm at 6 weeks post ESD
timeFrame: 6 weeks
measure: Number of adverse events in the PuraStat® and control arm of the study
timeFrame: 14 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmputh Hospitals NHS Trust
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Pradeep Bhandari, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: