Pancreatic duct strictures; biodegradable self-expandable versus plastic stents, a randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22266

Enrollment

Registered

2017-08-16

Start date

2018-01-01

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

Chronic pancreatitis/chronische pancreatitis Pancreatic duct strictures/Ductus pancreaticus stricturen

Interventions

Randomisation between endoscopic placement of a biodegradable self expandable stent or plastic stent to treat a fibrotic pancreatic duct stricture

Eligibility

Inclusion criteria

Inclusion criteria: Chronic pancreatitis patients with a symptomatic fibrotic PD stricture (located proximal from the spine), for which endoscopic drainage is considered.

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Contra-indication for endoscopy 3. CBD obstruction 4. Suspected pancreatic malignancy 5. Limited life expectancy (<1 year) 6. Pregnancy

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the number of therapeutic interventions during the 24 months follow-up period (defined as therapeutic endoscopic procedures related to the pancreatic duct stricture or pancreatic pain (ERCP, insertion of feeding tubes) and surgical procedures.	—

Secondary

Measure	Time frame
1. Clinical success, defined as no need for further PD drainage after stent extraction or resolution. 2. Complications. 3. Pain relief, defined as complete; Izbicki score 50% decrease. 4. Stricture recurrence, defined as need for a re-intervention for a PD stricture after stent extraction or resolution. 5. Conversion to surgery.	—

Contacts

Public ContactD.L. Cahen

Department of Gastroenterology & Hepatology, Room H-337

d.cahen@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)