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

This study has been completed.
Sponsor:
Collaborators:
Northwestern University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01015820
First received: November 12, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Procedure: EGD with EUS
Device: 4D-ELF

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Deoxyhemoglobin Concentration (DHb) [ Time Frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation ] [ Designated as safety issue: No ]
    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.

  • Mean Blood Vessel Radius (BVR) [ Time Frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation ] [ Designated as safety issue: No ]
    BVR serves as a marker for early increase of blood supply (EIBS).


Enrollment: 37
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: EGD with EUS
EUS was performed in order to measure blood flow in duodenum.
Device: 4D-ELF
During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
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.
Procedure: EGD with EUS
EUS was performed in order to measure blood flow in duodenum.
Device: 4D-ELF
During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015820

Locations
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32223
Sponsors and Collaborators
Mayo Clinic
Northwestern University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Principal Investigator: Michael B. Wallace, MD MPH Mayo Clinic
  More Information

Publications:
Responsible Party: Michael Wallace, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01015820     History of Changes
Other Study ID Numbers: 09-002596, R01CA128641, R01CA156186, R01EB003682, U01CA111257, CBET-1240416
Study First Received: November 12, 2009
Results First Received: May 29, 2014
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Pancreatic Cancer
Duodenum
Spectroscopy
Fiberoptic probe
4D-ELF

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014