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
6 other identifiers
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pancreatic-cancer
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 18, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
July 2, 2014
CompletedJuly 16, 2014
July 1, 2014
2.3 years
November 12, 2009
May 29, 2014
July 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
Mean Blood Vessel Radius (BVR)
BVR serves as a marker for early increase of blood supply (EIBS).
Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
Study Arms (2)
Cancer group
EXPERIMENTALParticipants 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.
Control group
OTHERParticipants 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.
Interventions
EUS was performed in order to measure blood flow in duodenum.
During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Northwestern Universitycollaborator
- National Cancer Institute (NCI)collaborator
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)collaborator
Study Sites (1)
Mayo Clinic Florida
Jacksonville, Florida, 32223, United States
Related Publications (1)
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.
PMID: 24861243RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size, unmatched cohorts
Results Point of Contact
- Title
- Dr. Michael B. Wallace
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B. Wallace, MD MPH
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 18, 2009
Study Start
June 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
July 16, 2014
Results First Posted
July 2, 2014
Record last verified: 2014-07