EUS Fiducial for Pancreas Surgery

NCT02863783 | Unknown DMC

• 1 other identifier: HS-16-00032
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Pancreas tumor localization makes minimally invasive surgical resection of pancreas tumors very challenging. Recently, an endoscopic ultrasound needle system has been developed which enables fiducial coils to be placed at the precise site of biopsy. INTERVENTION: At time of EUS guided biopsy the fine needle fiducial device will be used to place fiducials in the tumor. During surgery we will assess whether it improves tumor visualization. OBJECTIVES: We aim to determine the feasibility to use EUS guided fiducials placement to mark pancreas tumors in 20 patients and to assess whether the fiducials impact tumor visualization during pancreas surgery. STUDY POPULATION: Patients with pancreas adenocarcinoma or neuroendocrine lesions. STUDY ENDPOINTS: The main outcome will be to assess whether the coil may be successfully placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and ANALYSIS: Patients will be assessed at the time of EUS and surgery. This is a pilot analysis with the intention to assess feasibility and to gather data to power larger trials.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• The Proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted

  the primary outcome will be to assess whether the coil may be successfully placed. This will be reported as the proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted.

  3 months

• Relative Ease of Detection of the Tumor with Fiducial

  A co-primary outcome will be to assess whether the coil may detected at time of surgery. The proportion of patients in whom the fiducial may be easily detected will also be reported. The relative ease of detection of the tumor (with fiducial) will be compared to the ease of detection of similar sized tumors without the fiducial. A QUESTIONNAIRE will be used in which each of detection by the attending surgeon will be recorded with 5 being each of detection of similar (histology/size) tumor without fiducial.

  3 months

Secondary Outcomes (1)

• Pancreatitis, abdominal pain, infection, bleeding following placement.

  3 months

Study Arms (1)

Fiducial Placement

EXPERIMENTAL

EUS with Fiducial Placement into Tumor

Device: EUS with Fiducial

Interventions

EUS with Fiducial DEVICE

EUS will be used to place fiducial into pancreas tumor at time of biopsy

Fiducial Placement

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing endoscopic ultrasound for preoperative evaluation before planned pancreatic surgery for suspected adenocarcinoma and neuroendocrine tumors will be eligible. Rapid onsite evaluation is performed for all pancreas EUS as part of standard procedures. In this process the cytologist examines the cells and makes a determination whether the aspirate contains malignant or benign tissue. Fiducials will only be placed if cytologic confirmation of malignancy at the site is obtained.
• Tumors of sizes 5mm-4cm will be eligible as there may be benefit in marking small tumors given difficulty finding them with intraoperative ultrasound. Moderately large pancreas tumors may also cause fibrosis which makes identification for resection difficult. Coil placement in regions of cytologically confirmed malignant cells may be helpful. Fiducial markers will only be placed if the initial evaluation (abdominal computed tomography or magnetic resonance imaging) indicates resectability. If finding of nonresectability (i.e. liver metastasis) are seen on EUS then fiducials will not be placed.

You may not qualify if:

• \) Patients with INR \>1.5 2) Platelet county \<100 3) Metal allergy 4) Pregnant 5) \<18 years of age 6) Patients with pancreatic lymphoma will also be excluded as this is treated with chemotherapy.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (3)

• Park WG, Yan BM, Schellenberg D, Kim J, Chang DT, Koong A, Patalano C, Van Dam J. EUS-guided gold fiducial insertion for image-guided radiation therapy of pancreatic cancer: 50 successful cases without fluoroscopy. Gastrointest Endosc. 2010 Mar;71(3):513-8. doi: 10.1016/j.gie.2009.10.030.

  PMID: 20189509 BACKGROUND

• Farrell JJ, Sherrod A, Parekh D. EUS-guided fine-needle tattooing for preoperative localization of early pancreatic adenocarcinoma. Gastrointest Endosc. 2009 Jan;69(1):176-7. doi: 10.1016/j.gie.2008.03.1069. Epub 2008 Jul 2. No abstract available.

  PMID: 18599051 BACKGROUND

• Lennon AM, Newman N, Makary MA, Edil BH, Shin EJ, Khashab MA, Hruban RH, Wolfgang CL, Schulick RD, Giday S, Canto MI. EUS-guided tattooing before laparoscopic distal pancreatic resection (with video). Gastrointest Endosc. 2010 Nov;72(5):1089-94. doi: 10.1016/j.gie.2010.07.023.

  PMID: 21034909 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: August 11, 2016
• Study Start: November 23, 2016
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

US (1)