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.
ID
Bron
Verkorte titel
Aandoening
acute pancreatitis
systematic pancreatic fluid collection
endoscopic transmural drainage
self-expandable metal stent
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoints are safety and efficacy:<br>
1. Safety is expressed as the number of SAEs that are related to the procedure;<br>
2. Efficacy is expressed as the number of PFC resolutions at 3 months after drainage.
<br><br>
The intervention is considered safe when the maximum rate of SAE’s (related to the treatment) is 5%.<br>
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.
Achtergrond van het onderzoek
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.
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Total study duration is 6 months.
Onderzoeksproduct en/of interventie
Endoscopic transmural drainage of pancreatic fluid collecting with placement of self-expandable metal stent.
Algemeen / deelnemers
Academic Medical Center Amsterdam<br>
Meibergdreef 9
Tessa Verlaan
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665584
T.Verlaan@amc.uva.nl
Wetenschappers
Academic Medical Center Amsterdam<br>
Meibergdreef 9
Tessa Verlaan
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665584
T.Verlaan@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patient over 17 years;
2. Symptomatic pancreatic fluid collection that requires endoscopic drainage.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
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| NTR-old | NTR3793 |
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