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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26002
Enrollment
68
Registered
2013-01-14
Start date
2012-05-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pancreatitis pancreatic fluid collection double pigtail stent plastic stent endoscopic transmural drainage abnormal pancreatic duct pancreatic fluid collection recurrence

Interventions

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.

Sponsors

University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. PFC complicating chronic pancreatitis; 2. PFC after surgery; 3. Recurrence of prior treated PFC; 4. Acute-on-chronic pancreatitis.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Complications caused by spontaneous stent migration into the cyst; 2. Number of spontaneous stent migrations before removal.

Contacts

Public ContactTessa Verlaan

Dept. of Gastroenterology and Hepatology/ Dept. of Surgery Academic Medical Center Amsterdam Meibergdreef 9

T.Verlaan@amc.uva.nl+31 (0)20 5665584

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)