Actively Recruiting

Age: 18Years +
All Genders
ID03039309

Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety

Led by Portsmouth Hospitals NHS Trust · Updated on 2025-05-31

500

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of endoscopic submucosal dissection as a treatment for early gastrointestinal neoplasia, which involves removing abnormal tissue from the digestive tract. This observational study collects data from multiple centers in the United Kingdom to assess the effectiveness and safety of this technique over time. The study aims to understand how well the procedure works in removing lesions completely and safely. Participants undergo endoscopic submucosal dissection, a procedure that uses a special endoscopic knife to remove lesions from the gastrointestinal tract in one piece. The study gathers detailed information about each patient's lesion size and location, as well as demographic details. Data on the success of complete lesion removal and any complications or adverse events are collected. During the study, researchers monitor outcomes such as curative resection rates over two years, en bloc resection rates at the time of the procedure, complication rates within 28 days after the procedure, and mortality rates over two years. Patient information and procedure details are recorded, with follow-up assessments extending up to two years to evaluate long-term results and safety.

CONDITIONS

Brief Title

Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
  • Participant is able to give informed consent for participation in the study
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Endoscopic Submucosal Dissection

Duration - Procedure day plus 28 days post procedure

Participants undergo an endoscopic procedure to remove lesions within the gastrointestinal tract in one piece.

1 procedure visit and follow-up visits within 28 days

Long-term Monitoring

Duration - 2 years

Participants are followed for up to 2 years to assess the effectiveness and safety of the treatment.

Periodic follow-up visits over 2 years

Trial Site Locations

Total: 1 location

1

Portsmputh Hospitals NHS Trust

Portsmouth, United Kingdom, PO6 3LY

Actively Recruiting

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Research Team

P

Prof Pradeep Bhandari, MBBS, MD

S

Sharmila Subramaniam, MBBS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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