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This study will compare two needles to see which is one gives more tissue for better diagnosis while performing endoscopic ultrasound guided biopsy of lesions in the gastrointestinal wall.

Comparison of Franseen versus Reverse bevel needle for endoscopic ultrasound guided fine needle biopsy of subepithelial lesions: a randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071142
Enrollment
104
Registered
2024-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: K319- Disease of stomach and duodenum, unspecified

Interventions

Intervention1: EUS FNB using franseen needle: 1. First an Endoscopic ultrasound will be performed using a curvilinear array echoendoscope and localize and characterize the lesion. 2. Biopsy with Frans
one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes. 7. Cytopathologists and cytotechnicians will be blinded to the needle used. 8. Specimens cat

Sponsors

Jayanta Samanta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Patients referred to endoscopic ultrasound with tissue sampling of SELs of the oesophagus, stomach, duodenum or rectum. 3. Agree to receive follow up phone calls 4. Able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Coagulopathy or thrombocytopenia 2. Lack of consent 3. Pregnancy

Design outcomes

Primary

MeasureTime frame
sample adequacyTimepoint: day 14 after the procedure

Secondary

MeasureTime frame
1. Diagnostic accuracy 2. Histological quality of the sample 3. Yield of the first needle pass 4. Number of needle passes 5. Adverse events Timepoint: Day 14 after the procedure

Countries

India

Contacts

Public ContactJayanta Samanta

Postgraduate Institute of Medical Education and Research (PGIMER)

dj_samanta@yahoo.co.in9855319529

Outcome results

None listed

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