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Timing of removal of transluminal stents after endoscopic drainage of pancreatic fluid collections: A randomized controlled multicenter trial.


- candidate number14198
- NTR NumberNTR3791
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2013
- Secondary IDs35810 
- Public TitleTiming of removal of transluminal stents after endoscopic drainage of pancreatic fluid collections: A randomized controlled multicenter trial.
- Scientific TitleTiming of removal of transluminal stents after endoscopic drainage of pancreatic fluid collections: A randomized controlled multicenter trial-REMOVE trial.
- ACRONYMREMOVE
- hypothesisAn 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.
- Healt Condition(s) or Problem(s) studiedAcute pancreatitis, Abnormal pancreatic duct, Pancreatic fluid collection, Double pigtail stent, Plastic stent, Endoscopic transmural drainage
- Inclusion criteria1. 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 criteria1. PFC complicating chronic pancreatitis;
2. PFC after surgery;
3. Recurrence of prior treated PFC;
4. Acute-on-chronic pancreatitis.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-mei-2012
- planned closingdate1-mei-2016
- Target number of participants68
- InterventionsGroup 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.
- Primary outcomeRecurrence 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 outcome1. Complications caused by spontaneous stent migration into the cyst;
2. Number of spontaneous stent migrations before removal.
- TimepointsStudy patients will be followed for 18 months.
- Trial web siteN/A
- statusopen: patient inclusion
- 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 summaryRationale:
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.
- Main changes (audit trail)
- RECORD14-jan-2013 - 20-jan-2013


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