Clinical trial NCT06993402: DESI - Düsseldorfer ESD Study
Official title: DESI- Düsseldorfer ESD Register Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Oesophageal Tumour
Gastric Tumours
Duodenal Tumours
Colon Tumours
Rectal Tumours
Keywords: ESD
Lead sponsor: Evangelisches Krankenhaus Düsseldorf
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical success rate
timeFrame: during the procedure
measure: Complication rate
timeFrame: through study completion, an average of 5 years
measure: Histopahological result
timeFrame: up to 14 days after Procedure
Secondary outcomes:
measure: Complete resection rate (endoscopic)
timeFrame: up to 14 days after Procedure till histopathological results
measure: Clinical success rate (curative resection according to standard of care guidelines)
timeFrame: up to 14 days after Procedure till histopathological results
measure: 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)
timeFrame: about 4 weeks after the ESD
measure: Complication rate (total)
timeFrame: through study completion, an average of 1 year
measure: Contributing factors on the technical and clinical success rate originating with patient and investigator aspects
timeFrame: through study completion, an average of 1 year
measure: Dissection speed and rate of complications with different ESD devices
timeFrame: during the procedure / 1 day
measure: Recurrence rate after 3, 6, 12, 24 and 60 months (if available)
timeFrame: through study completion, an average of 5 year
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
state: NRW
Study officials:
affiliation: Evangelisches Krankenhaus Düsseldorf
name: Torsten PD Dr. med Beyna
role: PRINCIPAL_INVESTIGATOR
References: