Delayed bleeding, nabloeding. EMR, endoscopische mucosale resectie. Esofagus, esophagus, oesofagus, oesophagus. Duodenum. Colon.
Conditions
Interventions
Patients who undergo EMR of the esophagus, duodenum or colon will be treated with prophylactic Purastat application as standard of care.
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: - Age >18 years old - EMR of the: o Esophagus with lesions showing low- or high grade dysplasia within a Barrett segment or intramucosal cancer of 1-3 cm o Duodenum with lesions suspected as high-grade dysplasia or intramucosal cancer and measuring 1-3 cm in size o Colon with flat or sessile adenomas measuring 20 mm or larger. - Written informed consent
Exclusion criteria
Exclusion criteria: - Other prophylactic treatment, such as prophylactic clipping. - Major intraprocedural bleedings during EMR, for which intervention other than Purastat is indicated (e.g. clip deployment). NB. Prophylactic coagulation of vessels is allowed as it is preventive for recurrence, but not DB. - Multiple (>1) lesions treated in the same treatment, or within 30 days before and after the EMR. - ASA IV en V
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and safety of Purastat application, including the volume used per cm2 of resection surface, EMR procedure time, duration of gell application and side effects of Purastat application. | — |
Secondary
| Measure | Time frame |
|---|---|
| - DB within 30 days post-procedure - Severity of DB - Hospital presentations after EMR - Type and number of interventions, e.g. colonoscopy, surgery, angiography with or without coiling - Blood transfusions - Perforation rate - Length of hospital and intensive care unit (ICU) stay | — |
Contacts
Public ContactE. Soons
Geert Grooteplein-Zuid 10
Outcome results
None listed