|- candidate number||27754|
|- NTR Number||NTR6638|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-aug-2017|
|- Secondary IDs||volgt METC Erasmus MC Rotterdam, the Netherlands|
|- Public Title||Pancreatic duct strictures; biodegradable self-expandable versus plastic stents, a randomized trial
|- Scientific Title||Pancreatic duct strictures; biodegradable self-expandable versus plastic stents, a randomized trial
|- ACRONYM||BIOPT study|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Chronic pancreatitis, Pancreatic duct strictures|
|- Inclusion criteria||Chronic pancreatitis patients with a symptomatic fibrotic PD stricture (located proximal from the spine), for which endoscopic drainage is considered. |
|- Exclusion criteria||1. Age <18 years|
2. Contra-indication for endoscopy
3. CBD obstruction
4. Suspected pancreatic malignancy
5. Limited life expectancy (<1 year)
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-jan-2022|
|- Target number of participants||38|
|- Interventions||Randomisation between endoscopic placement of a biodegradable self expandable stent or plastic stent to treat a fibrotic pancreatic duct stricture |
|- Primary outcome||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.
|- Secondary outcome||1. Clinical success, defined as no need for further PD drainage after stent extraction or resolution.|
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.
|- Timepoints||T=6, 12, 18 and 24 months|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr D.L. Cahen|
|- CONTACT for SCIENTIFIC QUERIES||Dr D.L. Cahen|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||16-aug-2017 - 27-aug-2017|