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Optimal duration and type of metal stent in malignant distal biliary stricture - Retrospective Analysis of Patient Data (OPTIMIST-Trial)

Optimal duration and type of metal stent in malignant distal biliary stricture - Retrospective Analysis of Patient Data (OPTIMIST-Trial) - OPTIMIST-Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037288
Enrollment
1000
Registered
2025-06-30
Start date
2025-08-30
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

malignant distal common bile duct stricture

Interventions

Group 1: - Patients above 18 years of age in which a SEMS was applied into a malignant distal inoperable biliary duct stenosis. - Patients with at least one follow-up (reintervention with endoscopic r

Sponsors

Universitätsmedizin Göttingen Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients above 18 years of age in which a SEMS was applied into a malignant distal inoperable biliary duct stenosis. - Patients with at least one follow-up (reintervention with endoscopic retrograde cholangiopancreaticography and stent exchange)

Exclusion criteria

Exclusion criteria: - Patients with incompletely completed data - Patients with benign biliary stenosis

Design outcomes

Primary

MeasureTime frame
1. To propose an interval for stent replacement that helps prevent complications due to prolonged stent dwell time in patients with inoperable malignant distal biliary strictures 2. Gathering Information for the clinical management for replacing metal stents in distal malignant biliary strictures.

Secondary

MeasureTime frame
1. The average length of stay of a SEMS. 2. The overall prevalence and significance of complications associated with the use of SEMS.

Countries

Germany, Switzerland

Contacts

Public ContactAhmad Amanzada

Universitätsmedizin Göttingen Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie

ahmad.amanzada@med.uni-goettingen.de+49551 3962313

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026