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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01015820
Enrollment
37
Registered
2009-11-18
Start date
2010-06-30
Completion date
2012-10-31
Last updated
2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer, Duodenum, Spectroscopy, Fiberoptic probe, 4D-ELF

Brief summary

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

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.

Interventions

PROCEDUREEGD with EUS

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

DEVICE4D-ELF

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

Sponsors

Northwestern University
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older. * Informed written consent. * Patient scheduled for previously planned EGD with upper EUS * Patients with known adenocarcinoma of the pancreas included in the cancer group * Patients with abdominal imaging studies (e.g., CT abdomen or MRI abdomen) negative for malignancy in past 5 years included in the control group.

Exclusion criteria

* Unable to obtain biopsy specimen or fine-needle aspiration results of the pancreas lesion (e.g., coagulation disorder, inadequate sample) * Presence of malignant lesion in the pancreas or duodenum other than pancreas adenocarcinoma (e.g., neuroendocrine tumor, gastrointestinal stromal tumor) * Known familial disorder with high risk of pancreas cancer development (e.g., familial adenomatous polyposis syndrome, hereditary non-polyposis colorectal cancer syndrome, juvenile polyposis syndrome) * Significant family history of pancreatic cancer (at least one first degree relative with pancreatic cancer) * Presence of premalignant lesions (e.g., duodenal adenoma, pancreas intraductal papillary mucinous neoplasm) * Active visible inflammation/ulcer in the stomach or the duodenum * Patients with known chronic pancreatitis were excluded from cancer group. Chronic pancreatitis patients were allowed to be included in the control group only. * Known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.

Design outcomes

Primary

MeasureTime frameDescription
Deoxyhemoglobin Concentration (DHb)Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiationDeoxygenated 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.
Mean Blood Vessel Radius (BVR)Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiationBVR serves as a marker for early increase of blood supply (EIBS).

Countries

United States

Participant flow

Pre-assignment details

37 patients were enrolled in the study. Of these, 5 patients with neuroendocrine tumors and 2 patients with duodenal anatomy limiting the use of the probe were excluded because of screen failure.

Participants by arm

ArmCount
Cancer Group
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.
14
Control Group
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.
15
Total29

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudySuboptimal measurements10

Baseline characteristics

CharacteristicCancer GroupControl GroupTotal
Age, Continuous72 years
STANDARD_DEVIATION 10
63 years
STANDARD_DEVIATION 11
67 years
STANDARD_DEVIATION 12
Region of Enrollment
United States
14 participants15 participants29 participants
Sex: Female, Male
Female
3 Participants6 Participants9 Participants
Sex: Female, Male
Male
11 Participants9 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 140 / 15
serious
Total, serious adverse events
0 / 140 / 15

Outcome results

Primary

Deoxyhemoglobin Concentration (DHb)

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.

Time frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Cancer GroupDeoxyhemoglobin Concentration (DHb)Ampullary.6968475 alpha units95% Confidence Interval 0.22
Cancer GroupDeoxyhemoglobin Concentration (DHb)Proximal 1 cm from ampulla.6885187 alpha units95% Confidence Interval 0.29
Cancer GroupDeoxyhemoglobin Concentration (DHb)Distal periampullary.4442996 alpha units95% Confidence Interval 0.15
Cancer GroupDeoxyhemoglobin Concentration (DHb)Proximal periampullary.4785118 alpha units95% Confidence Interval 0.22
Cancer GroupDeoxyhemoglobin Concentration (DHb)Distal 1 cm from ampullary.7021826 alpha units95% Confidence Interval 0.35
Control GroupDeoxyhemoglobin Concentration (DHb)Proximal periampullary.43211449 alpha units95% Confidence Interval 0.33
Control GroupDeoxyhemoglobin Concentration (DHb)Ampullary.3483283 alpha units95% Confidence Interval 0.2
Control GroupDeoxyhemoglobin Concentration (DHb)Distal 1 cm from ampullary.4945491 alpha units95% Confidence Interval 0.28
Control GroupDeoxyhemoglobin Concentration (DHb)Distal periampullary.4831275 alpha units95% Confidence Interval 0.17
Control GroupDeoxyhemoglobin Concentration (DHb)Proximal 1 cm from ampulla.4654624 alpha units95% Confidence Interval 0.34
Comparison: Statistical significance p ≤ 0.05p-value: 0.001Wilcoxon (Mann-Whitney)
Primary

Mean Blood Vessel Radius (BVR)

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

Time frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Cancer GroupMean Blood Vessel Radius (BVR)Distal 1 cm from Ampulla.0030272 cm95% Confidence Interval 0.001
Cancer GroupMean Blood Vessel Radius (BVR)Proximal 1 cm from Ampulla.0027802 cm95% Confidence Interval 0.001
Cancer GroupMean Blood Vessel Radius (BVR)Distal Periampullary.002899 cm95% Confidence Interval 0.001
Cancer GroupMean Blood Vessel Radius (BVR)Proximal Periampullary.0023551 cm95% Confidence Interval 0.001
Cancer GroupMean Blood Vessel Radius (BVR)Ampullary.003088 cm95% Confidence Interval 0.001
Control GroupMean Blood Vessel Radius (BVR)Proximal Periampullary.0019793 cm95% Confidence Interval 0.001
Control GroupMean Blood Vessel Radius (BVR)Ampullary.002035 cm95% Confidence Interval 0.001
Control GroupMean Blood Vessel Radius (BVR)Distal 1 cm from Ampulla.0023467 cm95% Confidence Interval 0.001
Control GroupMean Blood Vessel Radius (BVR)Distal Periampullary.0024096 cm95% Confidence Interval 0.001
Control GroupMean Blood Vessel Radius (BVR)Proximal 1 cm from Ampulla.0020825 cm95% Confidence Interval 0.001
Comparison: Statistical significance p ≤ 0.05p-value: 0.03Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026