DESI - Düsseldorfer ESD Study

NCT ID: NCT06993402

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2035-09-30

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.

Conditions

Oesophageal Tumour; Gastric Tumours; Duodenal Tumours; Colon Tumours; Rectal Tumours

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Torsten Beyna

OTHER

Sponsor Role: lead

Responsible Party

Torsten Beyna

Head of the Medical Clinic and Gastroenterology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Torsten PD Dr. med Beyna

Role: PRINCIPAL_INVESTIGATOR

Evangelisches Krankenhaus Düsseldorf

Locations

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

DESI

Identifier Type: -

Identifier Source: org_study_id