Spectroscopy From Duodenum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pancreatic Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Test subject

Group Type EXPERIMENTAL

Spectroscopy device

Intervention Type OTHER

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.

Interventions

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Spectroscopy device

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.

Intervention Type OTHER

Eligibility Criteria

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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.