Endoscopic dilatation of pancreatic duct strictures with biodegradable self expandable stents will decrease the need for further therapeutic interventions (endoscopic or surgical), as compared to dilatation with plastic stents.
ID
Bron
Verkorte titel
Aandoening
Chronic pancreatitis/chronische pancreatitis
Pancreatic duct strictures/Ductus pancreaticus stricturen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is the number of therapeutic interventions during the 24 months follow-up period (defined as therapeutic endoscopic procedures related to the pancreatic duct stricture or pancreatic pain (ERCP, insertion of feeding tubes) and surgical procedures.
Achtergrond van het onderzoek
The study is a prospective randomized clinical intervention trial, in which three tertiary referral centres from the Netherlands, Belgium and Finland will participate. Thirty-eight chronic pancreatitis patients will be randomly assigned to undergo endoscopic dilatation of a pancreatic duct stricture, either with a biodegradable or plastic stent, and followed for 24 months at six-monthly intervals.
Doel van het onderzoek
Endoscopic dilatation of pancreatic duct strictures with biodegradable self expandable stents will decrease the need for further therapeutic interventions (endoscopic or surgical), as compared to dilatation with plastic stents.
Onderzoeksopzet
T=6, 12, 18 and 24 months
Onderzoeksproduct en/of interventie
Randomisation between endoscopic placement of a biodegradable self expandable stent or plastic stent to treat a fibrotic pancreatic duct stricture
Publiek
D.L. Cahen
Rotterdam
The Netherlands
d.cahen@erasmusmc.nl
Wetenschappelijk
D.L. Cahen
Rotterdam
The Netherlands
d.cahen@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Chronic pancreatitis patients with a symptomatic fibrotic PD stricture (located proximal from the spine), for which endoscopic drainage is considered.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age <18 years
2. Contra-indication for endoscopy
3. CBD obstruction
4. Suspected pancreatic malignancy
5. Limited life expectancy (<1 year)
6. Pregnancy
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6460 |
| NTR-old | NTR6638 |
| Ander register | METC Erasmus MC Rotterdam, the Netherlands : volgt |