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

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EGD with EUS

4D-ELF

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Duodenum, Spectroscopy, Fiberoptic probe, 4D-ELF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cancer group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Mean Blood Vessel Radius (BVR)

BVR serves as a marker for early increase of blood supply (EIBS).

Secondary Outcome Measures

Full Information

NCT ID

NCT01015820

First Posted

November 12, 2009

Last Updated

July 3, 2014

Sponsor

Mayo Clinic

Collaborators

Northwestern University, National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)

1. Study Identification

Unique Protocol Identification Number

NCT01015820

Brief Title

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

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Northwestern University, National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Pancreatic Cancer, Duodenum, Spectroscopy, Fiberoptic probe, 4D-ELF

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cancer group

Arm Type

Experimental

Arm 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.

Arm Title

Control group

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

EGD with EUS

Intervention Description

EUS was performed in order to measure blood flow in duodenum.

Intervention Type

Device

Intervention Name(s)

4D-ELF

Intervention Description

During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.

Primary Outcome Measure Information:

Title

Deoxyhemoglobin Concentration (DHb)

Description

Time Frame

Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation

Title

Mean Blood Vessel Radius (BVR)

Description

BVR serves as a marker for early increase of blood supply (EIBS).

Time Frame

Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael B. Wallace, MD MPH

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32223

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24861243

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.

Results Reference

result

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

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