Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

NCT ID: NCT02833558

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-04
• Study Completion Date: 2018-05-18

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.

Conditions

Gastrointestinal Haemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PuraStat®

Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to stop bleeding during ESD.

Group Type: EXPERIMENTAL

PuraStat®

Intervention Type: DEVICE

PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point

Standard Electrocautery

Control arm where standard electrocautery delivered via the endoscopic knife tip or coag grasper is used to achieve haemostasis during ESD

Group Type: OTHER

Electrocautery

Intervention Type: PROCEDURE

Electrocautery (coagulation current) to stop bleeding during ESD

Interventions

PuraStat®

PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point

Intervention Type: DEVICE

Electrocautery

Electrocautery (coagulation current) to stop bleeding during ESD

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pradeep Bhandari, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals NHS Trust

Locations

Portsmputh Hospitals NHS Trust

Portsmouth, , United Kingdom

Countries

United Kingdom

Other Identifiers

PHT/2015/106

Identifier Type: -

Identifier Source: org_study_id