Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4D-ELF | Device | — | UNRESOLVED |
| EGD with EUS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cancer group
- description
- 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.
- interventionNames
- Procedure: EGD with EUS
- Device: 4D-ELF
- type
- OTHER
- label
- Control group
- description
- 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.
- interventionNames
- Procedure: EGD with EUS
- Device: 4D-ELF
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTPatel M, Gomes A, Ruderman S, Hardee D, Crespo S, Raimondo M, Woodward T, Backman V, Roy H, Wallace M. Polarization gating spectroscopy of normal-appearing duodenal mucosa to detect pancreatic cancer. Gastrointest Endosc. 2014 Nov;80(5):786-93.e1-2. doi: 10.1016/j.gie.2014.03.031. Epub 2014 May 24. PMID 24861243