Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Haemorrhage
• Intervention / Treatment: Device: PuraStat®; Procedure: Electrocautery

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmputh Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PuraStat®; Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to stop bleeding during ESD.	Device: PuraStat®; PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point
Other: Standard Electrocautery; Control arm where standard electrocautery delivered via the endoscopic knife tip or coag grasper is used to achieve haemostasis during ESD	Procedure: Electrocautery; Electrocautery (coagulation current) to stop bleeding during ESD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 during the ESD procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The length of the procedure in the PuraStat® and control arm of the study		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		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).	6 weeks
Number of adverse events in the PuraStat® and control arm of the study		14 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Investigators: Principal Investigator: Pradeep Bhandari, MBBS, MD, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2016
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): May 18, 2018

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Bleeding; Endoscopic Submucosal Dissection; Endoscopy, Gastrointestinal
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: PHT/2015/106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes