Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

NCT02833558 | Completed DMC

• 1 other identifier: PHT/2015/106
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Haemorrhage

Keywords

Endoscopy, Gastrointestinal; Endoscopic Submucosal Dissection; Bleeding

Outcome Measures

Primary Outcomes (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

  Measured during the ESD procedure

Secondary Outcomes (4)

• 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

  6 weeks

• Number of adverse events in the PuraStat® and control arm of the study

  14 months

Study Arms (2)

PuraStat®

EXPERIMENTAL

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

Device: PuraStat®

Standard Electrocautery

OTHER

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

Procedure: Electrocautery

Interventions

PuraStat® DEVICE

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

PuraStat®

Electrocautery PROCEDURE

Electrocautery (coagulation current) to stop bleeding during ESD

Standard Electrocautery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmputh Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hemorrhage

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Pradeep Bhandari, MBBS, MD

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 14, 2016
• Study Start: May 4, 2016
• Primary Completion: April 12, 2018
• Study Completion: May 18, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)