Comparison Study in Pancreatic Fiducial Placement

NCT02376543 | Withdrawn FDA Device

• 1 other identifier: PRC14-1020 Pancreatic Fiducial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison Study between 19 gauge EUS FNA BNX Needle vs. 22 gauge EUS FNA BNX Needle in Pancreatic Fiducial Placement To Treat Pancreatic Cancer

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Total Cost Comparison

  Total cost of EUS guided fiducial placement in the pancreas to facilitate SBRT treatment of pancreatic cancer.

  Duration of Fiducial Placement Procedure; approx 30 minutes

• Total Time Comparison

  Time comparison of EUS guided fiducial placement in the pancreas to facilitate SBRT treatment

  Duration of fiducial placement procedure; up to 30 minutes

Secondary Outcomes (2)

• Migration Comparison

  Duration of SBRT treatment; up to 8 weeks.

• Complication Comparison

  Duration of SBRT treatment; Up to 8 weeks

Study Arms (2)

19 Gauge EUS FNA BNX

ACTIVE COMPARATOR

Subjects receiving EUS and fluoroscopic guidance for placement of fiducial markers into the pancreas will have the 19 gauge technique (ARM 1) of EUS guided fiducial marker technique.

Device: 19 Gauge EUS FNA BNX

22 Gauge EUS FNA BNX

ACTIVE COMPARATOR

Subjects receiving EUS and fluoroscopic guidance for placement of fiducial markers into the pancreas will have the 22 gauge technique (ARM 2) of EUS guided fiducial marker technique.

Device: 22 Gauge EUS FNA BNX

Interventions

19 Gauge EUS FNA BNX DEVICE

There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 19 gauge needle.

19 Gauge EUS FNA BNX

22 Gauge EUS FNA BNX DEVICE

There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 22 gauge needle.

22 Gauge EUS FNA BNX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that plan to undergo CyberKnife treatment for pancreatic cancer
• Subjects that are deemed physically able to undergo anesthesia (either Monitored Anesthesia Care (MAC) or general anesthesia)
• Subjects (or the subjects Legally Authorized Representative \[LAR\]) that have agreed to participate in the study and have signed Informed Consent
• Subjects 18 years of age or older
• Subject must be able to hold anticoagulants as per institutional standard of care
• Women of child bearing potential who are not pregnant as proven by a negative pregnancy test

You may not qualify if:

• Subjects that are unable to tolerate anesthesia for the procedure
• Subjects 17 or under
• Subjects that refuse treatment for pancreatic cancer d Subjects whose anticoagulants cannot be held
• e. Subjects who have distant metastatic disease f. Subjects who cannot or refuse EUS guided procedures. g Subjects who are pregnant

Sponsors & Collaborators

• Parkview Health: lead

Study Sites (1)

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Neil Sharma, MD

  Parkview Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Gastroenterologist

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 3, 2015
• Study Start: March 6, 2015
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

US (1)