Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection
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|ClinicalTrials.gov Identifier: NCT02833558|
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : June 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Haemorrhage||Device: PuraStat® Procedure: Electrocautery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomised Controlled Trial Comparing Purastat® to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection|
|Actual Study Start Date :||May 4, 2016|
|Actual Primary Completion Date :||April 12, 2018|
|Actual Study Completion Date :||May 18, 2018|
Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to stop bleeding during ESD.
PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point
Control arm where standard electrocautery delivered via the endoscopic knife tip or coag grasper is used to achieve haemostasis during ESD
Electrocautery (coagulation current) to stop bleeding during ESD
- 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 ]
- 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 ]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).
- Number of adverse events in the PuraStat® and control arm of the study [ Time Frame: 14 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833558
|Portsmputh Hospitals NHS Trust|
|Portsmouth, United Kingdom, PO6 3LY|
|Principal Investigator:||Pradeep Bhandari, MBBS, MD||Portsmouth Hospitals NHS Trust|