Biodegradable self-expandable stents for pancreatic duct strictures due to chronic pancreatitis

Biodegradable self-expandable stents for pancreatic duct strictures due to chronic pancreatitis - BSPD study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39445

Enrollment

Registered

2012-05-08

Start date

2012-12-12

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Pancreatic duct obstruction Pancreatic duct stricture

Interventions

The intervention consists of the endoscopic placement of a biodegradable self-expandable stent to cross the pancreatic duct stricture. This stent is expected to degrade within 6 months.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. A diagnosis of chronic pancreatitis, based on clinical symptoms in combination with morphological changes established by imaging studies (atrophy, calcifications or ductal changes) and/or pancreatic functional insufficiency. 2. A benign fibrotic pancreatic duct stricture. 3. Previous endoscopic dilatation with plastic stents for at least 6 months has failed to resolve this stricture.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years 2. Contra-indication for endoscopy; Roux-en-Y reconstruction 3. Suspected pancreatic malignancy 4. Limited life expectancy due to co-morbidity (

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is safety. Therefor, all complications will be documented.	—

Secondary

Measure	Time frame
Secondary outcome measures are; Successful stent placement Stent resolution Clinical success; pain relief Technical success; stricture resolution	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)