Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

Pancreatic cancer is the fourth leading cause of cancer death in the United States and is associated with a poor prognosis. The average life expectancy after diagnosis is approximately 5 to 8 months. At present, successful surgical resection is the only curative therapy that can improve long-term survival. However, it can be achieved only when a tumor is detected at an early stage. Unfortunately, due to non-specific symptoms associated with pancreatic cancer, it is commonly detected in the later stages of the disease. The investigators hypothesized that pancreatic cancer could be detected by measuring the changes in the early increase in blood supply (EIBS) found in the surrounding normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA allowed the use of this device in this research study.

Detailed description public domain (ClinicalTrials.gov)

According to field effect theory, by detecting microvasculature changes in the early increase of blood supply in the surrounding tissue neoplastic lesions can be identified from a distance. The objective of this study was to determine the feasibility and efficacy of a fiberoptic probe containing novel Polarization Gating Spectroscopy (PGS) technology to identify patients with pancreatic adenocarcinoma (PAC) by field effect theory. EIBS markers, deoxyhemoglobin concentration (DHb), and average blood vessel radius (BVR) were evaluated in patients with PAC versus controls. During the subjects' esophagogastroduodenoscopy (EGD) with upper endoscopic ultrasound (EUS), the new optic probe was inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope was withdrawn, the light optic probe was used to examine approximately 5 sections of the small bowel: 1) directly on the ampulla, 2) approximately 5 mm proximal from the ampulla, 3) approximately 5 mm distal from the ampulla, 4) 1 cm proximal from the ampulla, and 5) 1 cm distal from the ampulla. Spectroscopy measurements were obtained four times in each of these five peri-ampullary locations. The rest of the EGD and upper EUS endoscopy procedures were then completed as clinically indicated. During the procedure, all visualized mucosal abnormalities were recorded and photographed.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Deoxyhemoglobin Concentration (DHb) [Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation]. Mean, alpha units (95% Confidence Interval). Ampullary: Cancer Group (n=14): .6968475 (.562102 to .831593); Control Group (n=15): .3483283 (.2318606 to .4647961). Distal 1 cm from ampullary: Cancer Group (n=14): .7021826 (.4898464 to .9145189); Control Group (n=15): .4945491 (.3416003 to .647498). Distal periampullary: Cancer Group (n=14): .4442996 (.3415441 to .5470551); Control Group (n=15): .4831275 (.3904288 to .5758262). Proximal 1 cm from ampulla: Cancer Group (n=14): .6885187 (.5013549 to .8756826); Control Group (n=15): .4654624 (.2776132 to .6533117). Proximal periampullary: Cancer Group (n=14): .4785118 (.3417855 to .6152382); Control Group (n=15): .43211449 (.2399311 to .6243588). Analysis, Cancer Group vs Control Group: p=0.001; Wilcoxon (Mann-Whitney); superiority or other.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Mean Blood Vessel Radius (BVR) [Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation]. Mean, cm (95% Confidence Interval). Ampullary: Cancer Group (n=14): .003088 (.0022698 to .0039062); Control Group (n=15): .002035 (.0016118 to .0024582). Distal 1 cm from Ampulla: Cancer Group (n=14): .0030272 (.0022997 to .0037547); Control Group (n=15): .0023467 (.0019386 to .0027548). Distal Periampullary: Cancer Group (n=14): .002899 (.0021021 to .0036958); Control Group (n=15): .0024096 (.0021024 to .0027168). Proximal 1 cm from Ampulla: Cancer Group (n=14): .0027802 (.0021426 to .0034178); Control Group (n=15): .0020825 (.0015238 to .0026411). Proximal Periampullary: Cancer Group (n=14): .0023551 (.001627 to .0030832); Control Group (n=15): .0019793 (.0014618 to .0024968). Analysis, Cancer Group vs Control Group: p=0.03; Wilcoxon (Mann-Whitney); superiority or other.