Evangelisches Krankenhaus Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40217, Germany
NCT Number: NCT06993402
Safety and effectiveness of endoscopic submucosal dissection
Interested in participating?
Request Info18 year and older
All sexes
Observational
Düsseldorf, North Rhine-Westphalia, 40217, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: during the procedure
TSR, defined as rate of procedures with endoscopic en-bloc resection
Time frame: through study completion, an average of 5 years
Serious complications, (according to AGREE criteria), intraprocedural or late onset
Time frame: up to 14 days after Procedure
Histopathological result of R0 resection (margins are clean, vertical and lateral)
Time frame: up to 14 days after Procedure till histopathological results
Time frame: up to 14 days after Procedure till histopathological results
Time frame: about 4 weeks after the ESD
Time frame: through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
Time frame: during the procedure / 1 day
Time frame: through study completion, an average of 5 year
Torsten Beyna
Other
DESI- Düsseldorfer ESD Register Study
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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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