No registrations found.
ID
Source
Brief title
Health condition
acute pancreatitis
pancreatic fluid collection
double pigtail stent
plastic stent
endoscopic transmural drainage
abnormal pancreatic duct
pancreatic fluid collection recurrence
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence of a PFC (>6 cm or symptomatic) proximal to the initial PD disruption after an endoscopically drained PFC at or within 18 months after randomization.
Secondary outcome
1. Complications caused by spontaneous stent migration into the cyst;
2. Number of spontaneous stent migrations before removal.
Background summary
Rationale:
An acute pancreatitis can be complicated by a pancreatic fluid collection (PFC) which can be treated by endoscopic drainage with transluminal stent placement. In case of pancreatic duct (PD) disruption, it may be favorable, as for recurrence of the PFC, to leave the transluminal stents in situ at least during the first year following endoscopic drainage.
Objective:
The aim of this study is to compare recurrence rate of a PFC in patients with a PD disruption in which transluminal stents after endoscopic drainage and resolution of PFC are either removed early within 2 weeks of randomization (12-16 weeks after drainage) or 12 months after randomization (15 months after drainage).
Study design:
Randomized controlled multicenter trial.
Study population:
All consecutive patients over 18 years with an abnormal PD on S-MRCP that are being treated for a PFC by endoscopic drainage with transluminal stents.
Intervention:
Following transluminal endoscopic drainage, an S-MRCP will be made. Patients with an abnormal PD will be randomized to either stent removal within 2 weeks of randomization or stent removal at 12 months after randomization.
Main study parameters/endpoints:
Recurrence of a PFC (>6 cm or symptomatic) proximal to the initial PD disruption after endoscopic drainage at or within 18 months after randomization.
Study objective
An acute pancreatitis can be complicated by a pancreatic fluid collection (PFC) which can be treated by endoscopic drainage with transluminal stent placement. In case of pancreatic duct (PD) disruption, it may be favorable, as for recurrence of the PFC, to leave the transluminal stents in situ at least during the first year following endoscopic drainage.
The aim of this study is to compare recurrence rate of a PFC in patients with a PD disruption in which transluminal stents after endoscopic drainage and resolution of PFC are either removed early within 2 weeks of randomization (12-16 weeks after drainage) or 12 months after randomization (15 months after drainage).
Study design: Randomized controlled multicenter trial.
Study design
Study patients will be followed for 18 months.
Intervention
Group A:
1. Endoscopic stent removal within 2 weeks of randomization;
2. Follow-up S-MRCP at T=6 months, T= 12 months, T= 18 months.
Group B:
1. Endoscopic stent removal within 2 weeks of 12 month S-MRCP;
2. Follow-up S-MRCP at T=6 months, T=12 months, T=18 months.
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 18 years old;
2. PFC resolution (no remaining fluid collection larger than 3 cm);
3. Pigtail(s) positioned in remnant PFC;
4. Abnormal PD on S-MRCP performed 12-16 weeks after drainage;
5. Ductal dilation (≥ 5 mm in body or tail);
6. Ductal disruption;
7. Both ductal dilation and ductal disruption.
Exclusion criteria
1. PFC complicating chronic pancreatitis;
2. PFC after surgery;
3. Recurrence of prior treated PFC;
4. Acute-on-chronic pancreatitis.
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 | NL3625 |
| NTR-old | NTR3791 |
| Other | : 35810 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |