No registrations found.
ID
Source
Brief title
Health condition
acute pancreatitis
systematic pancreatic fluid collection
endoscopic transmural drainage
self-expandable metal stent
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
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.
Study objective
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.
Study design
Total study duration is 6 months.
Intervention
Endoscopic transmural drainage of pancreatic fluid collecting with placement of self-expandable metal stent.
Academic Medical Center Amsterdam<br>
Meibergdreef 9
Tessa Verlaan
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665584
T.Verlaan@amc.uva.nl
Academic Medical Center Amsterdam<br>
Meibergdreef 9
Tessa Verlaan
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665584
T.Verlaan@amc.uva.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3641 |
| NTR-old | NTR3793 |
| Other | ABR : 40756 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |