|- candidate number||14207|
|- NTR Number||NTR3793|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jan-2013|
|- Secondary IDs||40756 ABR|
|- Public Title||Transluminal drainage of pancreatic fluid collections using a self-expandable metallic stent.|
|- Scientific Title||Transluminal drainage of pancreatic fluid collections using a self-expandable metallic stent -PATENT trial.|
|- hypothesis||The efficacy of transluminal drainage of pancreatic fluid collections may be increased by creation of a larger fistula than currently possible with placement of multiple plastic endoprostheses.
|- Healt Condition(s) or Problem(s) studied||Acute pancreatitis, Pancreatic fluid collection, Endoscopic transmural drainage, Self-expandable metal stent|
|- Inclusion criteria||1. Patient over 17 years;|
2. Symptomatic pancreatic fluid collection that requires endoscopic drainage.
|- Exclusion criteria||1. Infected pancreatic necrosis;|
2. Recurrence of prior treated pancreatic fluid collection;
3. Not fulfilling standard criteria to undergo PFC drainage according to local guidelines;
4. ASA class IV or V.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-feb-2013|
|- planned closingdate||1-jun-2016|
|- Target number of participants||25|
|- Interventions||Endoscopic transmural drainage of pancreatic fluid collecting with placement of self-expandable metal stent.|
|- Primary outcome||The primary endpoints are safety and efficacy:|
1. Safety is expressed as the number of SAEs that are related to the procedure;
2. Efficacy is expressed as the number of PFC resolutions at 3 months after drainage.
The intervention is considered safe when the maximum rate of SAE’s (related to the treatment) is 5%.
The procedure is regarded effective if at least 85% of PFC have been resolved at 3 months.
PFC resolution is defined as a PFC < 3 cm.
|- Secondary outcome||1. ‘Ease of use’ measured as the scope-in and scope-out time interval during the procedure in which the SEMS is placed;|
2. Removability of covered self-expendable metallic stent after PFC resolution.
Removability and ease of use will be graded on a visual analogue scale of 0-10: 0 being not able to remove the SEMS and 10 very easy removal of the SEMS.
|- Timepoints||Total study duration is 6 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD. Tessa Verlaan|
|- CONTACT for SCIENTIFIC QUERIES||MD. Tessa Verlaan|
|- Sponsor/Initiator ||Academic Medical Center (AMC)|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Acute or chronic pancreatitis may be complicated by a (peri)pancreatic fluid collection (PFC) which can be treated by endoscopic drainage with transluminal stent placement. The efficacy of transluminal drainage of pancreatic fluid collections may be increased by creation of a larger fistula than currently possible with placement of multiple plastic endoprostheses.
To evaluate the safety and efficacy of using a covered self-expandable metallic stent (SEMS) for transluminal endoscopic drainage of a pancreatic fluid collection.
Prospective cohort (pilot) study with 25 patients.
All consecutive patients over 17 years with a symptomatic pancreatic fluid collection.
Placement of a covered self-expandable metallic stent for transluminal drainage of a pancreatic fluid collection.
Main study parameters/endpoints:
The primary endpoints are safety and efficacy.
|- Main changes (audit trail)|
|- RECORD||14-jan-2013 - 9-feb-2013|