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Pancreatic duct strictures; biodegradable self-expandable versus plastic stents, a randomized trial


- candidate number27754
- NTR NumberNTR6638
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-aug-2017
- Secondary IDsvolgt METC Erasmus MC Rotterdam, the Netherlands
- Public TitlePancreatic duct strictures; biodegradable self-expandable versus plastic stents, a randomized trial
- Scientific TitlePancreatic duct strictures; biodegradable self-expandable versus plastic stents, a randomized trial
- ACRONYMBIOPT study
- hypothesisEndoscopic 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.
- Healt Condition(s) or Problem(s) studiedChronic pancreatitis, Pancreatic duct strictures
- Inclusion criteriaChronic pancreatitis patients with a symptomatic fibrotic PD stricture (located proximal from the spine), for which endoscopic drainage is considered.
- Exclusion criteria1. Age <18 years
2. Contra-indication for endoscopy
3. CBD obstruction
4. Suspected pancreatic malignancy
5. Limited life expectancy (<1 year)
6. Pregnancy
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2022
- Target number of participants38
- InterventionsRandomisation between endoscopic placement of a biodegradable self expandable stent or plastic stent to treat a fibrotic pancreatic duct stricture
- Primary outcomeThe 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.
- Secondary outcome1. Clinical success, defined as no need for further PD drainage after stent extraction or resolution.
2. Complications.
3. Pain relief, defined as complete; Izbicki score <10, or partial; >50% decrease.
4. Stricture recurrence, defined as need for a re-intervention for a PD stricture after stent extraction or resolution.
5. Conversion to surgery.
- TimepointsT=6, 12, 18 and 24 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr D.L. Cahen
- CONTACT for SCIENTIFIC QUERIESDr D.L. Cahen
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD16-aug-2017 - 27-aug-2017


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