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Comparison of the 2 EUS guided tissue acquisition methods in better diagnosis of solid lesions (gastro-intestinal, pancreatic, biliary system and lymph nodes).

Comparative study of diagnostic performance of advanced imaging techniques versus Standard B-mode for Endoscopic Ultrasound guided tissue acquisition-An Analytical cross-sectional study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075450
Enrollment
168
Registered
2024-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: K869- Disease of pancreas, unspecified

Interventions

Intervention1: Contrast enhanced Endoscopic Ultrasound and Elastography guided Endoscopic Ultrasound: Patient undergoes EUS-guided tissue acquisition. Help of Contrast enhancement (will be studied for

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. All adult patients undergoing EUS-guided tissue acquisition (using FNB) for solid lesions (gastro-intestinal, pancreatic, biliary system and lymph nodes). 2. Able to comply with the study procedure and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years 2. Pregnancy 3. Presence of active bleed 4. Presence of coagulopathy, as evidenced by INR >1.5 and platelets 5. Patients on anti-coagulants or anti-platelets (eg- Clopidogrel). 6. Inability to sample because of intervening blood vessels seen during imaging or EUS (No suitable window found) 7. Poor patient tolerance to the procedure 8. Patients not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
Comparison between advanced imaging-techniques versus Standard B-mode for endoscopic ultrasound guided tissue acquisition in terms of Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Diagnostic Accuracy (DA), and Diagnostic yield (DY).Timepoint: Baseline - At the time of EUS- guided tissue sampling EUS-guided tissue Diagnosis - Day 4 of the procedure (when histopathology report is available) In case of negative diagnosis of malignancy - 6 months

Secondary

MeasureTime frame
1. Find out the elastography pattern of solid lesions undergoing EUS-guided tissue acquisition. 2. Find out the contrast enhancement pattern of solid lesions undergoing EUS-guided tissue acquisition.Timepoint: Baseline - At the time of EUS- guided tissue sampling EUS-guided tissue Diagnosis - Day 4 of the procedure (when histopathology report is available)

Countries

India, Indonesia

Contacts

Public ContactDr Nikhil Sonthalia

Institute of Gastrosciences, Apollo Multispecialty Hospital

guptatulika19@gmail.com9326093725

Outcome results

None listed

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