Transluminal drainage of PAncreatic fluid collections using a self-expandable metallic sTENT

Transluminal drainage of PAncreatic fluid collections using a self-expandable metallic sTENT - PATENT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41481

Enrollment

Registered

2013-01-31

Start date

2013-08-06

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

pancreas vocht collectie

Interventions

Patients will be treated under conscious sedation or with Propofol. Prior to the procedure prophylactic (broad spectrum) antibiotics will be administered. A linear echoendoscope will be introduced a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patient over 17 years • Symptomatic pancreatic fluid collection that requires endoscopic drainage

Exclusion criteria

Exclusion criteria: • Infected pancreatic necrosis • Recurrence of prior treated pancreatic fluid collection • Not fulfilling standard criteria to undergo PFC drainage according to local guidelines • ASA class IV or V

Design outcomes

Primary

Measure	Time frame
The primary endpoints are safety and efficacy.	—

Secondary

Measure	Time frame
• Removability of covered self-expendable metallic stent after PFC resolution • Number of complications • Number of stent migrations • Ease of use measured as the scope-in and scope-out time interval during the procedure	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)