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

Orlando Health, Inc.

Status: Active, not recruiting

Conditions: Adenocarcinoma of the Pancreas; Pancreatic Neoplasms; Pancreatic Cancer

Treatments: Procedure: 3 passes during EUS-guided fine needle biopsy; Procedure: 2 passes during EUS-guided fine needle biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05043532

21.069.05

1741103 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups

Two passes performed during EUS-FNB of pancreatic adenocarcinoma

Active Comparator group

Description:

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.

Treatment:

Procedure: 2 passes during EUS-guided fine needle biopsy

Three passes performed during EUS-FNB of pancreatic adenocarcinoma

Active Comparator group

Description:

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.

Treatment:

Procedure: 3 passes during EUS-guided fine needle biopsy