N/A
N=30
Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01015820 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Deoxyhemoglobin Concentration (DHb) — .6968475; .3483283; .7021826; .4945491 alpha units — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EGD with EUS (Procedure); 4D-ELF (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Deoxyhemoglobin Concentration (DHb) |
.6968475; .3483283; .7021826; .4945491; .4442996; .4831275 | 0.001 sig |
| PRIMARY Mean Blood Vessel Radius (BVR) |
.003088; .002035; .0030272; .0023467; .002899; .0024096 | 0.03 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01015820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.