FindTrial
Sign In

Comparison of Single and Double Plastic Biliary Stenting in Malignant Distal Common Bile Duct Stricture A Randomized Controlled Trial

A Randomized Controlled Trial Comparing Single Versus Double Plastic Biliary Stenting in Malignant Distal Common Bile Duct Stricture - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109303
Enrollment
120
Registered
2026-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: C241- Malignant neoplasm of ampulla of Vater Health Condition 2: C250- Malignant neoplasm of head of pancreas Health Condition 3: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 4: C170- Malignant neoplasm of duodenum

Interventions

Intervention1: Double Plastic Biliary Stenting in Malignant Distal Common Bile Duct Stricture: ERCP-guided placement two parallel plastic stents across the distal malignant

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Radiological, endoscopic and histopathological diagnosed case of malignant distal CBD stricture 2.Participants of both sexes age above 18 years those who are willing to give consent

Exclusion criteria

Exclusion criteria: 1.Age less than 18 years 2.Benign biliary strictures 3.Hilar (proximal) biliary obstruction 4.Previous biliary stenting 5.Altered anatomy precluding ERCP 6.Comorbidities like coronary artery disease, arrythmia, T2DM, HTN, CKD not getting anesthesia fitness

Design outcomes

Primary

MeasureTime frame
Requirements & number of re-interventions in single plastic stenting vs double plastic stenting in distal malignant CBD strictureTimepoint: From date of intervention (ERCP) till 6 months—

Secondary

MeasureTime frame
1.Technical success in 2 groups 2.Procedural time in 2 groups 3.Clinical and biochemical improvement at day 7, 14,28, at 3 month and 6 months. 4.Adverse events ERCP related complications, anesthesia related complications, cardiovascular events, Death. Timepoint: After intervention (ERCP) At day 7, 14,28, at 3 month and 6 months.—

Countries

India

Contacts

Public ContactDR DEBASHIS MISRA

IPGMER SSKM HOSPITAL

debb4you@gmail.com9830472292

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026