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To compare Endoscopic guided fine needle aspiration biopsy versus endoscopic guided fine needle aspiration cytology for diagnosis of solid pancreatic lesion

The role of Endoscopic ultrasound (EUS) guided Fine-needle biopsy (FNB) versus EUS guided fine-needle aspiration cytology (FNAC) for the diagnosis of solid pancreatic lesions- A prospective randomized study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047481
Enrollment
40
Registered
2022-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: C251- Malignant neoplasm of body of pancreas Health Condition 2: C250- Malignant neoplasm of head of pancreas Health Condition 3: C259- Malignant neoplasm of pancreas, unspecified Health Condition 4: C252- Malignant neoplasm of tail of pancreas Health Condition 5: K868- Other specified diseases of pancreas

Interventions

Intervention1: Endoscopic ultrasound (EUS) guided Fine-needle biopsy (FNB): Endoscopic ultrasound (EUS) guided Fine-needle biopsy (FNB) for the diagnosis of solid pancreatic lesions Control Interventi

Sponsors

PG Thesis Project AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients presenting for EUS evaluation of solid pancreatic lesions. 2. Accidentally discovered solid pancreatic lesions during EUS examination for any other cause 3. In patients between 18-80 years there is a solid pancreatic lesion with ambiguous imaging findings in CT or MRI

Exclusion criteria

Exclusion criteria: 1.Age under 18 years and more than 80 years 2.Small lesion with size 3.History of any prior gastric surgery or gastrectomy 4.Inability or refusal to provide informed consent. 5.Uncorrected Coagulopathy 6.Patients with cystic pancreatic lesions 7.Critically ill patients

Design outcomes

Primary

MeasureTime frame
To compare the diagnostic accuracy of EUS guided fine-needle biopsy (FNB) with EUS guided fine-needle aspiration cytology (FNAC) for tissue diagnosis in solid pancreatic lesionsTimepoint: 18 months

Secondary

MeasureTime frame
1.Proportion of patients with optimal histologic core present in EUS guided FNA & EUS guided FNB group (Histologic Core, tissue fragment, Histologic inadequacy) 2. Cellularity scoring in patients in EUS guided FNA & EUS guided FNB ( Scant, Low, Moderate, High)Timepoint: 18 months

Countries

India

Contacts

Public ContactDr Shubham Gupta

AIIMS Bhubaneswar

drhemantnayak@gmail.com9455583604

Outcome results

None listed

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