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PROSpective Assessment of Post EmR Recurrence (PROSPER)

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ClinicalTrials.gov Identifier: NCT02957058
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Study Description
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Brief Summary:
To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with thermal treatment applied to the defect margin. The primary aim of the study will be to ensure the safety of this approach and there will be constant monitoring to ensure that this is the case.

Condition or disease Intervention/treatment Phase
Colonic Adenoma Colonic Polyp Procedure: SCAR technique Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study Stratifying Patients to Follow up Intervals Based on Risk of Recurrence Post Wide Field Colonic EMR
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SERT 0, SCAR (low risk)
Patients with Sydney EMR Recurrence Tool (SERT scoring) score 0. These patients will be invited to return for follow up at 18 months and will have thermal ablation (SCAR technique) of the endoscopic resection defect margin.
 Procedure: SCAR technique
Thermal ablation of the EMR margin using ERBE Soft Coagulation (Effect 4, 80 watts) and the operator choice of endoscopic resection snare
Active Comparator: SERT 1-4, SCAR (high risk)
Patients with Sydney EMR Recurrence Tool score 1-4 (SERT scoring). These patients will be invited to return for follow up at 4-6 months and will have thermal ablation (SCAR technique) of the endoscopic resection defect margin.
 Procedure: SCAR technique
Thermal ablation of the EMR margin using ERBE Soft Coagulation (Effect 4, 80 watts) and the operator choice of endoscopic resection snare


Outcome Measures
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Primary Outcome Measures :
  1. Adenoma recurrence [ Time Frame: Variable dependent on SERT score ]
    Recurrence of adenoma at first and second surveillance colonoscopy


Secondary Outcome Measures :
  1. Need for surgery [ Time Frame: 18 months ]
    need for surgery due to adenoma recurrence or complication

  2. Bleeding after EMR [ Time Frame: 2 weeks ]
  3. Pain after EMR [ Time Frame: 2 weeks ]
  4. Delayed perforation after EMR [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All laterally spreading lesions >= 20mm referred to the named tertiary referral centres
  • Must consent to involvement

Exclusion Criteria:

  • Histology other than specified
  • Lesion involving the ileocaecal valve
  • Pregnancy: currently pregnant or attempting to become pregnant
  • Lactation: currently breastfeeding
  • Taken clopidogrel within 7 days
  • Taken warfarin within 5 days
  • Had full therapeutic dose unfractionated heparin within 6 hours
  • Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
  • Known clotting disorder
  • Previous attempt at EMR of the polyp referred for resection
Contacts and Locations
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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): NCT02957058


Contacts
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Contact: Michael Bourke +61296335953 reception@citywestgastro.com.au

Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Iddo Bar-Yishay, MD    89905555    iddo.baryishay@health.nsw.gov.au   
Sponsors and Collaborators
Western Sydney Local Health District
More Information
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Responsible Party: Professor Michael Bourke, Clinical Professor of Medicine, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02957058     History of Changes
Other Study ID Numbers: AU RED HREC/16/WMEAD/130
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Professor Michael Bourke, Western Sydney Local Health District:
Colonoscopy
Endoscopic Mucosal Resection
Adenoma Recurrence
EMR defect thermal ablation
Additional relevant MeSH terms:
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Adenoma
Recurrence
Colonic Polyps
Disease Attributes
Pathologic Processes
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical