The application of Purastat on the woundsurface will be feasible and safe.
ID
Bron
Verkorte titel
Aandoening
Delayed bleeding, nabloeding.
EMR, endoscopische mucosale resectie.
Esofagus, esophagus, oesofagus, oesophagus.
Duodenum.
Colon.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Rationale: Purastat is a matrix gel with aminoacid components aiding to cell recovery after tissue damage. Previous studies have shown that Purastat can be applied safely and effectively in oozing bleedings after ESD and has a stimulating effect on wound healing after 4 and 8 weeks. Based on these findings, it is hypothesized that Purastat has a beneficial effect on delayed bleeding rates after endomucosal resection (EMR) procedures.
Objective: To determine the feasibility and safety of Purastat for the prevention of delayed bleedings after EMR in the esophagus, duodenum and colon.
Study design: Prospective cohort study.
Study population: Patients >18 years old undergoing EMR for polyps or premalignant tissue such as Barrett’s esophagus, duodenum and/or colon.
Main study parameters/endpoints: Primary endpoints are the feasibility and safety of Purastat application. Secondary endpoints included the incidence of delayed bleedings within 30 days post procedure, defined as clinical significant blood loss for upper and lower GI.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As the application during the endoscopy is not invasive in itself, there is no significant burden for the patient. The number of hospital visits for the patients will not be influenced, and will all be part of standard of care.
Doel van het onderzoek
The application of Purastat on the woundsurface will be feasible and safe.
Onderzoeksopzet
- Day 0: application of Purastat after EMR-procedure
- Day 30: check if a DB did occur, and if so: collect additional information.
Onderzoeksproduct en/of interventie
Patients who undergo EMR of the esophagus, duodenum or colon will be treated with prophylactic Purastat application as standard of care.
Publiek
E. Soons
Postbus 9101
Nijmegen 6500 HB
The Netherlands
+316 50000996
elsa.soons@radboudumc.nl
Wetenschappelijk
E. Soons
Postbus 9101
Nijmegen 6500 HB
The Netherlands
+316 50000996
elsa.soons@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7140 |
| NTR-old | NTR7338 |
| Ander register | Lokale commissie mensgebonden onderzoek van het Radboudumc : 2018-4392 |