Oesophageal TumourNCT06993402
DESI - Düsseldorfer ESD Study
An observational study of Oesophageal Tumour and Gastric Tumours, run by Torsten Beyna at 1 site in Germany.
Trial summary
Safety and effectiveness of endoscopic submucosal dissection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Tumour, Gastric Tumours, Duodenal Tumours
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2024to Sep 2035
- How long will I take part?
- 5 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 with epithelial gastrointestinal lesions who receive an endoscopic submucosal dissection in the oesophagus, stomach, duodenum, colon or rectum in accordance with the guidelines (or according to the individual decision of the interdisciplinary tumour conference).
Who may be able to join
- signed consent form
- Indication for an ESD in the oesophagus, stomach, duodenum, colon or rectum
- Age >18 years
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40217
About this study
Official title: DESI- Düsseldorfer ESD Register Study
Safety and effectiveness of endoscopic submucosal dissection
Read the detailed description
Background and study objective The standard of care for premalignant and malignant mucosal lesions in the gastrointestinal track with limited submucosal invasion is an endoscopic resection. A curative resection of the neoplasia often necessitates an en-bloc resection, where the resection ends within healthy tissue (R0 resection). Endoscopic submucosal dissection (ESD) is a highly sophisticated resection technique for lesions in the oesophagus, stomach, duodenum, colon and rectum. Multiple studies in Asia already established the safety and efficacy of ESD. In several spezialized centres in the western world the ESD already replaced the endoscopic mucosal resectiona (EMR) as standart of care. The en-bloc resection facilitates an exact histopathological evaluation, thus leading to lower recurrence rates. Besides specified mucosal lesions, there is an increase in the use of ESD to resect expansive and submucosal lesions. Specialised centres like Evangelisches Krankenhaus Düsseldorf have a high number of ESD cases and use ubiquitous in the gastrointestinal tract. Besides the many advantages over EMR there is still the risk of peri- and postinterventional complications with ESD due to the highly demanding technique and the longer procedure duration. This is why patient selection is crucial factor (in this study). To evaluate the safety and efficacy of ESD more prospective data analysis in western centres are necessary. This data will be useful to develop new approaches to improve the method concerning safety and efficacy and patient selection.
- Keywords
- ESD
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
TSR, defined as rate of procedures with endoscopic en-bloc resection
Measured: during the procedure
Complication rate
Serious complications, (according to AGREE criteria), intraprocedural or late onset
Measured: through study completion, an average of 5 years
Histopahological result
Histopathological result of R0 resection (margins are clean, vertical and lateral)
Measured: up to 14 days after Procedure
Secondary outcomes (7)
Complete resection rate (endoscopic)
Measured: up to 14 days after Procedure till histopathological results
Clinical success rate (curative resection according to standard of care guidelines)
Measured: up to 14 days after Procedure till histopathological results
Enhances clinical success rate (no curative resection according to standard of care guidelines, but no further treatment necessary (after individual discussion of cases in tumorboard)
Measured: about 4 weeks after the ESD
Complication rate (total)
Measured: through study completion, an average of 1 year
Contributing factors on the technical and clinical success rate originating with patient and investigator aspects
Measured: through study completion, an average of 1 year
Dissection speed and rate of complications with different ESD devices
Measured: during the procedure / 1 day
Recurrence rate after 3, 6, 12, 24 and 60 months (if available)
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start10 Sep 2024
- Primary completionSep 2035 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal TumourStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Torsten Beyna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Torsten Beyna, Evangelisches Krankenhaus Düsseldorf
- Investigators
- Torsten PD Dr. med Beyna, Principal investigator, Evangelisches Krankenhaus Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993402
- Sponsor's protocol ID
- DESI
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESI- Düsseldorfer ESD Register Study
- ClinicalTrials.gov ID
- NCT06993402
- Acronym / sponsor ID
- DESI
- Keywords
- ESD
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Torsten BeynaUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 28 May 2025 (actual)
- 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.
Safety and effectiveness of endoscopic submucosal dissection
Detailed description
Background and study objective The standard of care for premalignant and malignant mucosal lesions in the gastrointestinal track with limited submucosal invasion is an endoscopic resection. A curative resection of the neoplasia often necessitates an en-bloc resection, where the resection ends within healthy tissue (R0 resection). Endoscopic submucosal dissection (ESD) is a highly sophisticated resection technique for lesions in the oesophagus, stomach, duodenum, colon and rectum. Multiple studies in Asia already established the safety and efficacy of ESD. In several spezialized centres in the western world the ESD already replaced the endoscopic mucosal resectiona (EMR) as standart of care. The en-bloc resection facilitates an exact histopathological evaluation, thus leading to lower recurrence rates. Besides specified mucosal lesions, there is an increase in the use of ESD to resect expansive and submucosal lesions. Specialised centres like Evangelisches Krankenhaus Düsseldorf have a high number of ESD cases and use ubiquitous in the gastrointestinal tract. Besides the many advantages over EMR there is still the risk of peri- and postinterventional complications with ESD due to the highly demanding technique and the longer procedure duration. This is why patient selection is crucial factor (in this study). To evaluate the safety and efficacy of ESD more prospective data analysis in western centres are necessary. This data will be useful to develop new approaches to improve the method concerning safety and efficacy and patient selection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epithelial gastrointestinal lesions who receive an endoscopic submucosal dissection in the oesophagus, stomach, duodenum, colon or rectum in accordance with the guidelines (or according to the individual decision of the interdisciplinary tumour conference).
Key inclusion criteria (3 listed)
- signed consent form
- Indication for an ESD in the oesophagus, stomach, duodenum, colon or rectum
- Age >18 years
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical success rate
Time frame: during the procedure
TSR, defined as rate of procedures with endoscopic en-bloc resection
Complication rate
Time frame: through study completion, an average of 5 years
Serious complications, (according to AGREE criteria), intraprocedural or late onset
Histopahological result
Time frame: up to 14 days after Procedure
Histopathological result of R0 resection (margins are clean, vertical and lateral)
7 secondary outcomes
Complete resection rate (endoscopic)
Time frame: up to 14 days after Procedure till histopathological results
Clinical success rate (curative resection according to standard of care guidelines)
Time frame: up to 14 days after Procedure till histopathological results
Enhances clinical success rate (no curative resection according to standard of care guidelines, but no further treatment necessary (after individual discussion of cases in tumorboard)
Time frame: about 4 weeks after the ESD
Complication rate (total)
Time frame: through study completion, an average of 1 year
Contributing factors on the technical and clinical success rate originating with patient and investigator aspects
Time frame: through study completion, an average of 1 year
Dissection speed and rate of complications with different ESD devices
Time frame: during the procedure / 1 day
Recurrence rate after 3, 6, 12, 24 and 60 months (if available)
Time frame: through study completion, an average of 5 year
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 28 May 2025.
- Individual participant dataSharing planned: No
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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.
Torsten PD Dr. med Beyna principal investigator
Evangelisches Krankenhaus Düsseldorf
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 Oesophageal Tumour and Gastric Tumours, run by Torsten Beyna at 1 site in Germany.
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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 28 May 2025. 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 Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: during the procedure). The study lists 3 primary outcomes in all. 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 28 May 2025.