D0005 - Pilot Trial of Endoscopic Ultrasound-Guided Fiducial Marker Placement to Facilitate Intraoperative Management of Pancreas Tumors

Tuesday, October 25, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

Patrick W. Chang, MD

University of Southern California
Los Angeles, CA

Award: Presidential Poster Award

Patrick W. Chang, MD¹, Jonathan Sadik, MD¹, Wissam Kiwan, MD¹, Ravi J. Kankotia, MD¹, Christopher Ko, MD², Jessica Serna, MS¹, Alex Rodriguez, BS¹, Helen Lee, ANPC¹, Mohd Raashid Sheikh, MD¹, Ara B. Sahakian, MD³, James L. Buxbaum, MD³
¹University of Southern California, Los Angeles, CA; ²University of Michigan, Ann Arbor, MI; ³Keck School of Medicine, University of Southern California, Los Angeles, CA

Introduction: Localization of small pancreatic tumors is challenging due to minimally invasive approach pancreatic resection. EUS-guided fiducial marker placement (EUS-FMP) to aid intraoperative identification has been proposed, but its feasibility has not been explored in a controlled prospective manner. The objective of this study is to determine the technical feasibility of placement of EUS guided fiducial placement to mark pancreas tumors in 20 patients and to assess fiducial utility during surgery(ClinicalTrials.gov Identifier: NCT02863783).

Methods: In this prospective study, we enrolled 20 consecutive patients in two tertiary-care referral medical centers undergoing consideration for pancreatic masses. These patients underwent successful Endoscopic Ultrasound-Fiducial Marker Placement (EUS-FMP) at time of initial confirmation by EUS-Fine needle aspiration (FNA) and Rapid OnSite Evaluation (ROSE). The co-primary outcomes assessed are 1) the successful placement by EUS-FMP, and 2) relative ease of detection of tumor with fiducial during pancreatic surgery based on Likert Scale from 1-10. Secondary outcomes include post-EUS-FMP complications including pancreatitis, abdominal pain, infection and bleeding up to 3 months following placement.

Results: Between January 2017 and March 2022, a total of twenty patients, twelve female and eight male, underwent EUS for confirmation of pancreatic tumor and simultaneous EUS-FMP prior to a possible surgery (Table 1). A total of thirteen patients had pancreatic adenocarcinoma, six had pancreatic neuroendocrine tumors, and one patient had pancreatic solid pseudopapillary neoplasm. The average tumor size was 2.2 +/- 1.4 cm. Eleven patients underwent surgery and all patients had negative surgical margins on subsequent pathology. For patients that underwent surgical excision, average tumor size on EUS was 1.7 +/- 0.9 cm (range: 0.5-3.6cm). Average operation time was 429 +/- 170 minutes (range: 144-690 minutes). The mean ease of fiducial placement was 9.1+/-1.3 and mean ease of detection of lesion during surgery was 7.8+/- 2.2. One of twenty patients had pancreatitis.

Discussion: EUS-FMP is feasible at initial diagnosis of EUS-FNA during pancreatic lesions. Placement of fiducials may improve clinical detection during surgical management. Gold coil fiducial markers are safe prior to surgery with minimal adverse three month follow up outcomes.

Figure: Figure 1. Schematic for screening, enrollment and surgery for EUS-FMP

Patient and Tumor Characteristics
Patient characteristics (Mean +/- SD)
Age (y)	58 +/- 14
Body Mass Index	25 +/- 4
Weight Loss (lb)	16 +/- 16
Demographics and comorbidities N (%)
Female Gender	12 (60)
Hispanic Ethnicity	11 (55)
Diabetes	6 (30)
Endoscopic findings (Mean +/- SD)
Tumor Size (cm)	2.2 +/- 1.4
Pancreatic duct diameter (mm)	3.7 +/- 1.6
Bile duct diameter (mm)	9.8 +/- 6.2
Tumor type N (%)
Adenocarcinoma	13 (65)
Neuroendocrine	6 (30)
Other	1 (5)

Table: Table 1. Patient and tumor characteristics of patients undergoing EUS-FMP

Disclosures:

Patrick Chang indicated no relevant financial relationships.

Jonathan Sadik indicated no relevant financial relationships.

Wissam Kiwan indicated no relevant financial relationships.

Ravi Kankotia indicated no relevant financial relationships.

Christopher Ko indicated no relevant financial relationships.

Jessica Serna indicated no relevant financial relationships.

Alex Rodriguez indicated no relevant financial relationships.

Helen Lee indicated no relevant financial relationships.

Mohd Raashid Sheikh indicated no relevant financial relationships.

Ara Sahakian: Boston Scientific – Consultant. Cook Medical – Consultant. Noah Medical – Consultant. Olympus – Consultant.

James Buxbaum: Boston Scientific – Consultant. Olympus – Consultant.

Patrick W. Chang, MD¹, Jonathan Sadik, MD¹, Wissam Kiwan, MD¹, Ravi J. Kankotia, MD¹, Christopher Ko, MD², Jessica Serna, MS¹, Alex Rodriguez, BS¹, Helen Lee, ANPC¹, Mohd Raashid Sheikh, MD¹, Ara B. Sahakian, MD³, James L. Buxbaum, MD³. D0005 - Pilot Trial of Endoscopic Ultrasound-Guided Fiducial Marker Placement to Facilitate Intraoperative Management of Pancreas Tumors, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.