Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

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Pancreatic Neoplasms

Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.

Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.

EUS was performed in order to measure blood flow in duodenum.

EGD with EUS

During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.

4D-ELF

Michael B. Wallace, MD MPH

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.

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.

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

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

Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.

BVR serves as a marker for early increase of blood supply (EIBS).

Northwestern University

National Cancer Institute (NCI)

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Mayo Clinic

M.D.

Cancer Group

Control Group

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the baseline analysis population.

Dr. Michael B. Wallace

Ampullary

Distal 1 cm from ampullary

Distal periampullary

Proximal 1 cm from ampulla

Proximal periampullary

Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.

Deoxyhemoglobin Concentration (DHb)

Distal 1 cm from Ampulla

Distal Periampullary

Proximal 1 cm from Ampulla

Proximal Periampullary

Mean Blood Vessel Radius (BVR)

Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.

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