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Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02833558
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : June 26, 2018
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date June 26, 2018
Actual Study Start Date  ICMJE May 4, 2016
Actual Primary Completion Date April 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection
Official Title  ICMJE Randomised Controlled Trial Comparing Purastat® to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Haemorrhage
Intervention  ICMJE
  • Device: PuraStat®
    PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point
  • Procedure: Electrocautery
    Electrocautery (coagulation current) to stop bleeding during ESD
Study Arms  ICMJE
  • Experimental: PuraStat®
    Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to stop bleeding during ESD.
    Intervention: Device: PuraStat®
  • Standard Electrocautery
    Control arm where standard electrocautery delivered via the endoscopic knife tip or coag grasper is used to achieve haemostasis during ESD
    Intervention: Procedure: Electrocautery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2016)
Actual Study Completion Date  ICMJE May 18, 2018
Actual Primary Completion Date April 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02833558
Other Study ID Numbers  ICMJE PHT/2015/106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Portsmouth Hospitals NHS Trust
Study Sponsor  ICMJE Portsmouth Hospitals NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pradeep Bhandari, MBBS, MD Portsmouth Hospitals NHS Trust
PRS Account Portsmouth Hospitals NHS Trust
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP