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

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.

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 patients will be followed for 18 months.

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.