ClinicalTrials.gg
RecruitingNCT03039309ESDUKUpdated Sep 17, 2026

Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

An observational study in Endoscopic Submucosal Dissection, sponsored by Portsmouth Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Portsmouth Hospitals NHS Trust · Observational

From the registry’s dates

  • Started Aug 2016; still recruiting 10 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Data will be collected from participating centres on en bloc resection, curative resection, R0 resection and complications/adverse events over a 2 year follow up period.

Demographic details on the patients included in the study will be captured alongside details on the size and location of their early gastrointestinal dysplastic/neoplastic lesions.

02

Conditions studied

  • Endoscopic Submucosal Dissection

Keywords

  • Endoscopic Submucosal Dissection
03

In context

Lead sponsor

Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients under the age of 18
  • Patients unable to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • ProcedureEndoscopic Submucosal Dissection

    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.

06

What researchers measure

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)

    Time frame: 2 years

Secondary outcomes

  1. En bloc resection rate

    % of en bloc resections obtained at the time of initial endoscopic submucosal dissection

    Time frame: At the time of procedure

  2. Complication rates

    % of complications noted within 28 days following endoscopic submucosal dissection

    Time frame: 28 days post procedure

  3. Mortality rates

    % of patients alive at the end of the 2 year follow up

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Portsmputh Hospitals NHS Trust
    Portsmouth, PO6 3LY, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03039309
Lead sponsor
Portsmouth Hospitals NHS Trust
Responsible party
Sponsor
First posted
Feb 1, 2017
Start date
Aug 5, 2016
Primary completion
Aug 5, 2028 (estimated)
Completion
Aug 5, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Prof Pradeep Bhandari, MBBS, MD
Contact
pradeep.bhandari@porthosp.nhs.uk
02392286000 ext. 5852
Sharmila Subramaniam, MBBS
Contact
Sharmila.Subramaniam@porthosp.nhs.uk
02392286000 ext. 5852
Prof Pradeep Bhandari, MBBS, MD
principal investigator · Portsmouth Hospitals NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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