EUS Fiducial for Pancreas Surgery

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.

Sex

All

Minimum age

18 Years

Maximum age

100 Years

Inclusion Criteria:

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.

Exclusion Criteria:

* 1\) 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.

• BACKGROUNDPark 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
• BACKGROUNDFarrell 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
• BACKGROUNDLennon 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
• DERIVEDChang PW, Sadik J, Sahakian AB, Kankotia R, Ko C, Serna J, Rodriguez A, Lee H, Kulkarni S, Genyk Y, Sheikh M, Buxbaum JL. A Preliminary Controlled Trial of Endoscopic Ultrasound-guided Fiducial Markers to Guide Pancreas Surgery. J Clin Gastroenterol. 2024 Oct 1;58(9):931-936. doi: 10.1097/MCG.0000000000001952. PMID 38112649