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Covered self-expandable metal stents for benign biliary strictures: a prospective multicenter trial.


- candidate number6101
- NTR NumberNTR1910
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2009
- Secondary IDs09-017 / NL26692.041.09 MEC UMC Utrecht / CCMO
- Public TitleCovered self-expandable metal stents for benign biliary strictures: a prospective multicenter trial.
- Scientific TitleCovered self-expandable metal stents for benign biliary strictures: a prospective multicenter trial.
- ACRONYMPLAMET 2 study
- hypothesisBenign biliary strictures occur most frequently after surgical procedures, chronic pancreatitis or iatrogenic ampullary stenosis. Traditionally, surgery has been the treatment of choice. A less invasive alternative is endoscopic or percutaneous dilatation with plastic stent placement. The major drawbacks of plastic stents are the need for multiple procedures to avoid cholangitis caused by stent clogging and to dilate in a stepwise fashion. As a consequence of their larger diameter, uncovered self expandable metal stents (SEMS) have been introduced in effort to maintain duct patency for a longer period than with plastic stents, which will result in fewer procedures. Uncovered SEMS have been shown to be effective, but long term stent patency is limited due to tissue ingrowth through the mesh in uncovered stents. Furthermore, surgical management of patients with SEMS is difficult, as these devices can hardly be removed due to embedding into the biliary wall. These disadvantages of uncovered SEMS have led to the development of covered SEMS, with the potential benefit that these stents can be removed. In addition, covered stents, because of their diameter, may serve as a dilator. This could avoid stepwise (every 3 months for one year) dilatation,as is done with plastic stents and eliminates the necessity of multiple procedures. A limited number of prospective studies on the use of covered SEMS in patients with benign CBD obstruction has been performed.
- Healt Condition(s) or Problem(s) studiedBenign CBD obstruction, Covered self-expandable metal stent
- Inclusion criteria1. Benign CBD obstruction confirmed with a CT san and/or EUS (no signs of metastases or invasive growth);
2. Serum bilirubin >50 mmol or clinical symptoms of an obstructive biliary stricture;
3. Age older than 18 years;
4. Written informed consent;
5. Stent placement feasible during ERCP.
- Exclusion criteriaKnown previous surgical history with hepatico-jejunostomy, choledocho-jejunostomy or choledocho-duodenostomy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-jul-2010
- Target number of participants20
- InterventionsPlacement of a covered self expandable metal stent during ERCP.
- Primary outcomeInitial technical result; stent patency, complications, technical result of stent removal and long-term outcome.
- Secondary outcomeSee above.
- TimepointsDuring ERCP, a covered SEMS will be placed. Prior to stent placement the biliary stricture will be dilated to a diameter of 10 Fr, if indicated to advance the SEMS introduction device. Dilation and stent placement will be performed during ERCP. One week after stent placement serum gamma-glutamyl transferase (-GT) and bilirubin will be measured. After 3 months, ERCP will be performed to remove the covered SEMS and another blood sample will be collected to measure -GT and bilirubin. One week, 3, 6, and 9 months after stent removal another blood sample will be collected to measure the same parameters. In case of signs of symptoms of CBD obstruction, an ERCP will be performed and a plastic stent will be placed.
- Trial web sitewww.utrechtdigestivecenter.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P. Boeckel, van
- CONTACT for SCIENTIFIC QUERIESProf. dr., MD, PhD P.D. Siersema
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryRationale:
Benign biliary strictures occur most frequently after surgical procedures, chronic pancreatitis or iatrogenic ampullary stenosis. Traditionally, surgery has been the treatment of choice. A less invasive alternative is endoscopic or percutaneous dilatation with plastic stent placement. The major drawbacks of plastic stents are the need for multiple procedures to avoid cholangitis caused by stent clogging and to dilate in a stepwise fashion. As a consequence of their larger diameter, uncovered self expandable metal stents (SEMS) have been introduced in effort to maintain duct patency for a longer period than with plastic stents, which will result in fewer procedures. Uncovered SEMS have been shown to be effective, but long term stent patency is limited due to tissue ingrowth through the mesh in uncovered stents. Furthermore, surgical management of patients with SEMS is difficult, as these devices can hardly be removed due to embedding into the biliary wall. These disadvantages of uncovered SEMS have led to the development of covered SEMS, with the potential benefit that these stents can be removed. In addition, covered stents, because of their diameter, may serve as a dilator. This could avoid stepwise (every 3 months for one year) dilatation,as is done with plastic stents and eliminates the necessity of multiple procedures. A limited number of prospective studies on the use of covered SEMS in patients with benign CBD obstruction has been performed.

Objective:
The aim of this study is to determine safety, patency of placement and long term symptom-free outcome of a covered self expandable metal stent in patients with a benign CBD stricture. Study design: A prospective multicenter study in 21 Dutch centres.

Study population:
Patients with a benign CBD obstruction as a complication of a surgical procedure, chronic pancreatitis or (iatrogenic) ampullary stricture.

Intervention:
After informed consent, all patients included in this study will be given a covered SEMS following preceding dilation during ERCP.

Main study parameters/endpoints:
Initial technical result; stent patency, complications, technical result of stent removal and long-term outcome.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
During ERCP, a covered SEMS will be placed. Prior to stent placement the biliary stricture will be dilated to a diameter of 10 Fr, if indicated to advance the SEMS introduction device. Dilation and stent placement will be performed during ERCP. One week after stent placement serum gamma-glutamyl transferase (g-GT) and bilirubin will be measured. After 3 months, ERCP will be performed to remove the covered SEMS and another blood sample will be collected to measure g-GT and bilirubin. One week, 3, 6, and 9 months after stent removal another blood sample will be collected to measure the same parameters. In case of signs of symptoms of CBD obstruction, an ERCP will be performed and a plastic stent will be placed.
- Main changes (audit trail)
- RECORD15-jul-2009 - 10-okt-2009


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