Spectroscopy From Duodenum

Olympus Corporation445 enrolled

Overview

Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.

Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient. The investigators would like to look at the spectroscopy technique for pancreatic cancer diagnosis via an upper endoscopy. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis. Therefore this study can be positioned as a feasibility study.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

445

Conditions

Pancreatic Adenocarcinoma

Interventions

Spectroscopy deviceOTHER

Spectrum data are collected using spectroscopy device via an instrumental channel of endoscope. Then spectrum data is analyzed. Numerical features (spectral slope and width of spectrum) are used for statistical analysis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Common inclusion criterion * Age is 18 years or older. * Informed consent was obtained. * Inclusion criterion for normal cohort * An upper GI endoscopy is scheduled to check upper abdominal symptoms. * No findings of pancreatic disorder as documented by CT or MRI or EUS * Inclusion criterion for PC suspicious cohort \* A EUS or ERCP is scheduled to suspected pancreatic disorder. Exclusion Criteria: * Common exclusion criterion * Severe cardiac disease * Severe respiratory disease * Bleeding disorders * Pregnancy

Locations (4)

Mayo Clinic Florida

Jacksonville, Florida, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Hôpital Erasme

Brussels, Brussels Capital, Belgium

Università Cattolica del Sacro Cuore

Rome, Lazio, Italy

Outcomes

Primary Outcomes

The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort

To clarify that there is the statistically-significant difference between two cohorts.

Time frame: 1 year

Secondary Outcomes

The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants.

A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.

Time frame: 1 year

Data from ClinicalTrials.gov

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