A clinical trial to compare the efficacy and Safety of two method of contrast cholangiography- gravity versus push injection

Efficacy and Safety of Gravity Dependent and Hand Held ‘Push’ Injection Method of Contrast Cholangiography: Validation of a Pilot Study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059252

Enrollment

Registered

2023-10-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: K838- Other specified diseases of biliary tract

Interventions

Intervention1: Push Cholangiogram: ased antibiotic to be given 5minutes prior to cholangiogram or empirically Inj. Cefaperazone sulbactam for prophylaxis of cholangitis in patients with a sterile bi

Eligibility

Inclusion criteria

Inclusion criteria: All the patients with indwelling biliary tubes (T tube, PTC, PTBD, PCC, ENBD) requiring direct cholangiography

Exclusion criteria

Exclusion criteria: Patients with active cholangitis or complete biliary obstruction.

Design outcomes

Primary

Measure	Time frame
Adverse reactions occurring within 24 hrs following the cholangiogram, and later, shall be recorded and classified as minor and major adverse reactions. Follow up to be done at 15 days and then again at 6months to look for any delayed adverse effects. Minor adverse reactions include two or more of - 1. Tachycardia (Heart Rate > 100/min) 2. Low grade fever ( 3. Abdominal pain and nausea in absence of fever which were significant enough to be noted in clinical records. 4. Alteration in LFTs or leucocytosis in absence of clinical manifestations (subclinical cholangitis) Major adverse reactions include two or more of - 1. High grade fever ( > 38.0 Degree Celsius) 2. Presence of Chills 3. Tachycardia 4. Hypotension 5. Oliguria 6. Need for unclamping the T Tube / PTBD catheterTimepoint: 24hrs, 15days, 6months	—

Measure

Time frame

Adverse reactions occurring within 24 hrs following the cholangiogram, and later, shall be recorded and classified as minor and major adverse reactions. Follow up to be done at 15 days and then again at 6months to look for any delayed adverse effects. Minor adverse reactions include two or more of - 1. Tachycardia (Heart Rate > 100/min) 2. Low grade fever ( 3. Abdominal pain and nausea in absence of fever which were significant enough to be noted in clinical records. 4. Alteration in LFTs or leucocytosis in absence of clinical manifestations (subclinical cholangitis) Major adverse reactions include two or more of - 1. High grade fever ( > 38.0 Degree Celsius) 2. Presence of Chills 3. Tachycardia 4. Hypotension 5. Oliguria 6. Need for unclamping the T Tube / PTBD catheterTimepoint: 24hrs, 15days, 6months

—

Secondary

Measure	Time frame
Efficacy of both the techniques shall be analysed in terms of the objective achieved. The objectives of cholangiograms include: 1. Demonstration of any residual filling defect 2. Demonstration of Peri tubal/Anastomotic leak 3. Stenosis of the anastomosis 4. Persistence of cystobiliary communicationTimepoint: 24hrs	—

Countries

India

Contacts

Public ContactPayal Kaw

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

kaw.payal@gmail.com8716099831

Outcome results

None listed

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