Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer

Not Applicable

Active, not recruiting

• Conditions: Adenocarcinoma of the Pancreas; Pancreatic Cancer; Pancreatic Neoplasms
• Interventions: Procedure: 2 passes during EUS-guided fine needle biopsy; Procedure: 3 passes during EUS-guided fine needle biopsy

• Registration Number: NCT05043532
• Lead Sponsor: Orlando Health, Inc.

Brief Summary

This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer

Detailed Description

Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of \>90%.

Molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice.

The primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.

Study Timeline

• Study Start: 2021-08-18
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Age 18 years and over
2. Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy

Exclusion Criteria

1. Age < 18 years
2. Females who are pregnant
3. Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound
4. Biopsied pancreatic mass is not adenocarcinoma on pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two passes performed during EUS-FNB of pancreatic adenocarcinoma	2 passes during EUS-guided fine needle biopsy	Once the pancreatic mass is identified on endoscopic ultrasound examination, total of two passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.
Three passes performed during EUS-FNB of pancreatic adenocarcinoma	3 passes during EUS-guided fine needle biopsy	Once the pancreatic mass is identified on endoscopic ultrasound examination, total of three passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.

Primary Outcome Measures

Name	Time	Method
Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy	7 days	Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy of pancreatic adenocarcinoma, with comparison between two and three passes during fine needle biopsy

Secondary Outcome Measures

Name	Time	Method
Rate of technical success	1 day	Rate of technical success of EUS-guided fine needle biopsy. Technical success is defined as the successful completion of the EUS-guided fine needle biopsy procedure.
Type of actionable mutations detected on molecular profiling	7 days	Type of actionable mutations detected on molecular profiling
Number of actionable mutations detected on molecular profiling	7 days	Number of actionable mutations detected on molecular profiling
Rate of procedure-related adverse events	7 days	Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States