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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01015820
First received: November 12, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

The investigators are testing a device called 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 has allowed the use of this device in this research study.

During your endoscopy ultrasound, the new optic probe will be inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope is getting withdrawn, the light optic probe will be used to examine approximately 5 sections of the small bowel. The probe will be gently placed against the lining of the small bowel and each reading takes less than a second to record.


Condition Intervention
Pancreatic Cancer
 Procedure: Endoscopic Ultrasound (EUS)
Device: EUS/4D-ELF

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group 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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To investigate whether EIBS measurements from pancreatic cancer will be elevated when measured in the peri-ampullary duodenal mucosa, in comparison to the same measures from control patients undergoing upper endoscopy without know pancreatic cancer. [ Time Frame: Completion of Study Procedure (EUS) ] [ Designated as safety issue: No ]

Enrollment: 30
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: Diagnostic
Measuring blood flow in the duodenum in patients with pancreatic cancer
 Procedure: Endoscopic Ultrasound (EUS)
EUS performed in order to measure blood flow in duodenum for pancreatic cancer
Other Names:
  • 4D-ELF
  • EIBS
  • Pancreatic Cancer
  • Duodenum
Device: EUS/4D-ELF
During the EUS, blood flow will be measured in the duodenum with the 4D-ELF device.
Other Names:
  • Endoscopic Ultrasound
  • EIBS

Detailed Description:

The overall goal of this study is to test a technique that in the future may allow endoscopic detection of pancreatic neoplasia. The study is a single group, prospective, open label pilot study designed to assess the feasibility and efficacy of 4D-ELF in detecting EIBS in peri-ampullary duodenal mucosa in pancreatic cancer patients compared to control patients. The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up is complete after the initial evaluation.

  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 EUS or ERCP.
  • Patients with known adenocarcinoma of the pancreas.

Exclusion Criteria:

  • Presence of conditions not allowing biopsy or FNA if clinically indicated (e.g. coagulation disorder).
  • Significant family history of pancreatic cancer.
  • Patients with other tumors of the pancreas or duodenum (i.e neuroendocrine tumors, carcinoid, GIST, known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc)).
  • Patient with premalignant lesions (duodenal adenoma, IPMN).
  • Active duodenitis/ulcer from any cause (peptic, H pylori etc).
  • Patients with known chronic pancreatitis will be excluded from study group (not control group however).
  • Know pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.
  Contacts and Locations
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
Investigators
Principal Investigator: Michael B. Wallace, MD MPH Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael Wallace, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01015820     History of Changes
Other Study ID Numbers: 09-002596
Study First Received: November 12, 2009
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Pancreatic Cancer
Duodenum
Increase Blood Flow

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

ClinicalTrials.gov processed this record on May 21, 2013