Comparison of the performance of two different stent types, viz lumen apposing metal stent and tubular stent while performing endoscopic ultrasound-guided drainage of the obstructed bile duct in patients with distal block of the bile duct due to malignancy.

Lumen apposing metal stents versus Covered tubular self-expanding metal stents for EUS-guided choledochoduodenostomy In Distal malignant biliary obstruction: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077821

Enrollment

Registered

2024-12-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: EUS CDS using lumen apposing metal stent: After informed consent and randomization, the patients will be subjected to EUS-guided biliary drainage by choledochoduodenostomy (EUS-CDS) usi

Eligibility

Inclusion criteria

Inclusion criteria: malignant distal biliary obstruction naive/prior ERCP failure or unsuccessful ERCP informed consent

Exclusion criteria

Exclusion criteria: hilar or proximal biliary obstruction altered GI anatomy Unfit for endoscopic procedure uncorrectable coagulopathy or thrombocytopenia pregnancy

Design outcomes

Primary

Measure	Time frame
Rates of re-intervention for recurrent biliary obstructionTimepoint: 6 months	—

Secondary

Measure	Time frame
1. Technical success 2. Clinical success 3. Effective biliary drainage (EBD) 4. Rates of adverse events 5. Duration of hospital stay 6. Procedure time 7. Time to develop recurrent biliary obstruction (1,3,6 months) 8. Evaluation of stent patency (1,3,6 months) or if stent dysfunction occurs (whichever is earlier) Timepoint: 1. Technical Success, procedure time at the time of procedure 2. Clinical Success and EBD at 1 month 3. Duration of hospital stay at index admission 4. time to RBO and stent patency at 1, 3 , 6 months	—

Measure

Time frame

1. Technical success 2. Clinical success 3. Effective biliary drainage (EBD) 4. Rates of adverse events 5. Duration of hospital stay 6. Procedure time 7. Time to develop recurrent biliary obstruction (1,3,6 months) 8. Evaluation of stent patency (1,3,6 months) or if stent dysfunction occurs (whichever is earlier) Timepoint: 1. Technical Success, procedure time at the time of procedure 2. Clinical Success and EBD at 1 month 3. Duration of hospital stay at index admission 4. time to RBO and stent patency at 1, 3 , 6 months

—

Countries

India

Contacts

Public ContactJayanta Samanta

Postgraduate Institute of Medical Education and Research, Chandigarh

dj_samanta@yahoo.co.in9855319529

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026