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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
Sponsor:
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Haemorrhage Device: PuraStat® Procedure: Electrocautery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The length of the procedure in the PuraStat® and control arm of the study [ Time Frame: Measured during the ESD procedure ]
  2. 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 ]
  3. 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).

  4. Number of adverse events in the PuraStat® and control arm of the study [ Time Frame: 14 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
United Kingdom
Portsmputh Hospitals NHS Trust
Portsmouth, United Kingdom, PO6 3LY
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Investigators
Principal Investigator: Pradeep Bhandari, MBBS, MD Portsmouth Hospitals NHS Trust

Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02833558     History of Changes
Other Study ID Numbers: PHT/2015/106
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Portsmouth Hospitals NHS Trust:
Endoscopy, Gastrointestinal
Endoscopic Submucosal Dissection
Bleeding

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemostatics
Coagulants