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Transluminal drainage of pancreatic fluid collections using a self-expandable metallic stent.


- candidate number14207
- NTR NumberNTR3793
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2013
- Secondary IDs40756 ABR
- Public TitleTransluminal drainage of pancreatic fluid collections using a self-expandable metallic stent.
- Scientific TitleTransluminal drainage of pancreatic fluid collections using a self-expandable metallic stent -PATENT trial.
- ACRONYMPATENT
- hypothesisThe 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) studiedAcute pancreatitis, Pancreatic fluid collection, Endoscopic transmural drainage, Self-expandable metal stent
- Inclusion criteria1. Patient over 17 years;
2. Symptomatic pancreatic fluid collection that requires endoscopic drainage.
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate1-jun-2016
- Target number of participants25
- InterventionsEndoscopic transmural drainage of pancreatic fluid collecting with placement of self-expandable metal stent.
- Primary outcomeThe 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 outcome1. ‘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.
- TimepointsTotal study duration is 6 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. Tessa Verlaan
- CONTACT for SCIENTIFIC QUERIESMD. Tessa Verlaan
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryAcute 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.

Objective:
To evaluate the safety and efficacy of using a covered self-expandable metallic stent (SEMS) for transluminal endoscopic drainage of a pancreatic fluid collection.

Study design:
Prospective cohort (pilot) study with 25 patients.

Study population:
All consecutive patients over 17 years with a symptomatic pancreatic fluid collection.

Intervention:
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)
- RECORD14-jan-2013 - 9-feb-2013


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