NCT03039309

Brief Summary

Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Aug 2016Aug 2028

Study Start

First participant enrolled

August 5, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2028

Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

10 years

First QC Date

January 23, 2017

Last Update Submit

May 27, 2025

Conditions

Endoscopic Submucosal Dissection

Keywords

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

  • Curative resection rate

    % of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)

    2 years

Secondary Outcomes (3)

  • En bloc resection rate

    At the time of procedure

  • Complication rates

    28 days post procedure

  • Mortality rates

    2 years

Interventions

Endoscopic Submucosal DissectionPROCEDURE

Endoscopic submucosal dissection is an endoscopic resection technique that utilises an endoscopic knife to remove lesions within the gastrointestinal tract in an en bloc fashion.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing endoscopic submucosal dissection for early gastrointestinal neoplasia (e.g colorectal/gastric/oesophageal) in tertiary referral centres in the UK

You may qualify if:

  • Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
  • Participant is able to give informed consent for participation in the study

You may not qualify if:

  • Patients under the age of 18
  • Patients unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmputh Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

RECRUITING

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Prof Pradeep Bhandari, MBBS, MD

    Portsmouth Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Pradeep Bhandari, MBBS, MD

CONTACT

02392286000pradeep.bhandari@porthosp.nhs.uk

Sharmila Subramaniam, MBBS

CONTACT

02392286000Sharmila.Subramaniam@porthosp.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 1, 2017

Study Start

August 5, 2016

Primary Completion (Estimated)

August 4, 2026

Study Completion (Estimated)

August 4, 2028

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations

GB(1)