Colon Tumours, Duodenal Tumours, Gastric Tumours, Oesophageal Tumour, Rectal Tumours
Conditions
Keywords
ESD
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.
Interventions
None listed
Sponsors
Torsten Beyna
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | during the procedure | TSR, defined as rate of procedures with endoscopic en-bloc resection |
| Complication rate | through study completion, an average of 5 years | Serious complications, (according to AGREE criteria), intraprocedural or late onset |
| Histopahological result | up to 14 days after Procedure | Histopathological result of R0 resection (margins are clean, vertical and lateral) |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate (total) | through study completion, an average of 1 year |
| Contributing factors on the technical and clinical success rate originating with patient and investigator aspects | through study completion, an average of 1 year |
| Complete resection rate (endoscopic) | up to 14 days after Procedure till histopathological results |
| Recurrence rate after 3, 6, 12, 24 and 60 months (if available) | through study completion, an average of 5 year |
| Dissection speed and rate of complications with different ESD devices | during the procedure / 1 day |
| Clinical success rate (curative resection according to standard of care guidelines) | 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) | about 4 weeks after the ESD |
Countries
Germany
Outcome results
None listed