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Single tube drainage versus double tube drainage for reduction of jaundice in cancers of bile duct.

Safety and efficacy of unilateral versus bilateral percutaneous transhepatic biliary drainage in the management of patients with malignant obstruction of the biliary hilum: A randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005725
Enrollment
120
Registered
2015-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- hilar malignancy

Interventions

Intervention1: Unilateral PTBD: A thin tube is inserted from outside the body into the bile duct only on one side Intervention2: unilateral ptbd: single thin tube inserted to drain bile Control Interv

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who consent for the study. 2. Age 18 to 70 years. 3. Good performance status (ECOG 0, 1, 2). 4. Diagnosis of malignant hilar block with obstructive jaundice requiring biliary drainage.

Exclusion criteria

Exclusion criteria: 1. ASA Grade IV. 2. Patients unfit for PTBD (Coagulopathy, allergy to contrast, allergy to lignocaine, etc.) 3. Patients with hilar block with patent confluence of the right and left biliary system (as seen on pre-procedure imaging or on the contrast cholangiogram performed during the procedure.)

Design outcomes

Primary

MeasureTime frame
1. Compare the safety of unilateral versus bilateral percutaneous transhepatic biliary drainage by evaluating non-occurrence of cholangitis, early and late complications. 2. To compare clinically successful drainage in unilateral versus bilateral percutaneous transhepatic biliary drainage groups. Timepoint: on follow up

Secondary

MeasureTime frame
1. To compare the technical success of unilateral versus bilateral percutaneous transhepatic biliary drainage. 2. Compare the quality of life post procedure. 3. To compare time taken for and completeness of relief of pruritis. Timepoint: on follow up

Countries

India

Contacts

Public ContactDr Hemant Jain

AIIMS, New Delhi

nagranjan@gmail.com01126594879

Outcome results

None listed

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