A study to compare the two techniques to drain the biliary system in patients having biliary tree obstruction at the hilum, viz, radiological method using percutaneous technique and endoscopic ultrasound guided stent placement

Comparison of percutaneous transhepatic biliary drainage (PTBD) versus endoscopic ultrasonography (EUS) guided hepaticogastrostomy (HGS) in malignant hilar biliary obstruction: a randomized controlled trial - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077586

Enrollment

Registered

2024-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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-guided HGS: After informed consent and randomization, the patient will be subjected to EUS-guided hepaticogastrostomy (EUS-HGS) in this arm. The procedure will be performed under mo

Eligibility

Inclusion criteria

Inclusion criteria: malignant hilar biliary obstruction with type I and II block requiring biliary drainage Failed or non-feasible ERCP cases informed consent

Exclusion criteria

Exclusion criteria: Malignant Hilar obstruction with type IIIa, IIIb and IV block benign cause of biliary obstruction atrophied left lobe unfit for endoscopic procedure Non-correctable coagulopathy, thrombocytopenia pregnant female

Design outcomes

Primary

Measure	Time frame
Rate of clinical success between the two arms of EUS-HGS and PTBDTimepoint: at 1 month post procedure	—

Secondary

Measure	Time frame
1. To compare technical success between both the groups 2. Re-intervention rates between both the groups 3. Procedure related adverse events as per ASGE- Lexicon guidelines between the two groups 4. Surgical outcomes and their complications between both the groups 5. Hospital and ICU stay 6. Quality of life assessment 7. Any additional intervention on follow up due to recurrent biliary obstruction Timepoint: 6 months	—

Measure

Time frame

1. To compare technical success between both the groups 2. Re-intervention rates between both the groups 3. Procedure related adverse events as per ASGE- Lexicon guidelines between the two groups 4. Surgical outcomes and their complications between both the groups 5. Hospital and ICU stay 6. Quality of life assessment 7. Any additional intervention on follow up due to recurrent biliary obstruction Timepoint: 6 months

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Countries

India

Contacts

Public ContactMarikanty Adarsh

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