Clinical trial NCT01015820: Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Official title: Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Duodenum
Spectroscopy
Fiberoptic probe
4D-ELF
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Cancer Institute (NCI)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2009-11-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Deoxyhemoglobin Concentration (DHb)
timeFrame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
measure: Mean Blood Vessel Radius (BVR)
timeFrame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael B. Wallace, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel 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.