Endoscopic Submucosal DissectionESDUKNCT03039309
Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom
An observational study of Endoscopic Submucosal Dissection, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Submucosal Dissection
- What is being tested?
- Endoscopic Submucosal Dissection
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2016to 5 Aug 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing endoscopic submucosal dissection for early gastrointestinal neoplasia (e.g colorectal/gastric/oesophageal) in tertiary referral centres in the UK
Who may be able to join
- Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
- Participant is able to give informed consent for participation in the study
Who cannot join
- Patients under the age of 18
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Portsmputh Hospitals NHS Trust
Portsmouth, PO6 3LY
Alice Mortlock, +2392 286000 ext. 3774, alice.mortlock@porthosp.nhs.uk
Linda Harndahl, +2392 286000, linda.harndahl@porthosp.nhs.uk
About this study
Official title: Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety
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.
- Conditions
- Endoscopic Submucosal Dissection
- Being tested
- Endoscopic Submucosal Dissection
- Keywords
- Endoscopic Submucosal Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal DissectionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Curative resection rate
% of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)
Measured: 2 years
Secondary outcomes (3)
En bloc resection rate
% of en bloc resections obtained at the time of initial endoscopic submucosal dissection
Measured: At the time of procedure
Complication rates
% of complications noted within 28 days following endoscopic submucosal dissection
Measured: 28 days post procedure
Mortality rates
% of patients alive at the end of the 2 year follow up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start5 Aug 2016
- Primary completion5 Aug 2028 (estimated)
- Study completion5 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Prof Pradeep Bhandari, MBBS, MD, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039309
- Sponsor's protocol ID
- PHT/2016/45
- Acronym
- ESDUK
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2017
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety
- ClinicalTrials.gov ID
- NCT03039309
- Acronym / sponsor ID
- ESDUK / PHT/2016/45
- Conditions
- Endoscopic Submucosal Dissection
- Keywords
- Endoscopic Submucosal Dissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 5 Aug 2028 (estimated)
- Study completion
- 5 Aug 2028 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endoscopic submucosal dissection for early gastrointestinal neoplasia (e.g colorectal/gastric/oesophageal) in tertiary referral centres in the UK
Key inclusion criteria (2 listed)
- Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
- Participant is able to give informed consent for participation in the study
Key exclusion criteria (2 listed)
- Patients under the age of 18
- Patients unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Submucosal DissectionEndoscopic submucosal dissection is an endoscopic resection technique that utilises an endoscopic knife to remove lesions within the gastrointestinal tract in an en bloc fashion. | Procedure or surgery | – |
Primary outcome
Curative resection rate
Time frame: 2 years
% of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)
3 secondary outcomes
En bloc resection rate
Time frame: At the time of procedure
Complication rates
Time frame: 28 days post procedure
Mortality rates
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Pradeep Bhandari, MBBS, MD principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Submucosal Dissection, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Pradeep Bhandari, MBBS, MD (02392286000 ext. 5852, pradeep.bhandari@porthosp.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curative resection rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.