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Enrolling by Invitation

NCT Number: NCT06993402

DESI - Düsseldorfer ESD Study

Safety and effectiveness of endoscopic submucosal dissection

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40217, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed consent form
  • Indication for an ESD in the oesophagus, stomach, duodenum, colon or rectum
  • Age >18 years

Exclusion criteria

  • Age < 18 years

Treatment and study plan

Primary outcomes

  1. Technical success rate

    Time frame: during the procedure

    TSR, defined as rate of procedures with endoscopic en-bloc resection

  2. Complication rate

    Time frame: through study completion, an average of 5 years

    Serious complications, (according to AGREE criteria), intraprocedural or late onset

  3. Histopahological result

    Time frame: up to 14 days after Procedure

    Histopathological result of R0 resection (margins are clean, vertical and lateral)

Secondary outcomes

  1. Complete resection rate (endoscopic)

    Time frame: up to 14 days after Procedure till histopathological results

  2. Clinical success rate (curative resection according to standard of care guidelines)

    Time frame: up to 14 days after Procedure till histopathological results

  3. 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

  4. Complication rate (total)

    Time frame: through study completion, an average of 1 year

  5. 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

  6. Dissection speed and rate of complications with different ESD devices

    Time frame: during the procedure / 1 day

  7. Recurrence rate after 3, 6, 12, 24 and 60 months (if available)

    Time frame: through study completion, an average of 5 year

Sponsors and collaborators

Lead sponsor

Torsten Beyna

Other

Registry information

Official study title

DESI- Düsseldorfer ESD Register Study

Important dates

Study start
2024
Primary completion
2035
Study completion
2035
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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