An observational study in Oesophageal Tumour, Gastric Tumours and Duodenal Tumours, sponsored by Torsten Beyna. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Torsten Beyna · Observational
Safety and effectiveness of endoscopic submucosal dissection
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →This is the only study on the registry with Torsten Beyna as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Technical success rate
TSR, defined as rate of procedures with endoscopic en-bloc resection
Time frame: during the procedure
Complication rate
Serious complications, (according to AGREE criteria), intraprocedural or late onset
Time frame: through study completion, an average of 5 years
Histopahological result
Histopathological result of R0 resection (margins are clean, vertical and lateral)
Time frame: up to 14 days after Procedure
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
Plan to share: No
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