NCT01753479

Spectroscopy From Duodenum

Duodenal Spectroscopy Study for Cancer Diagnosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Olympus Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-06-30
• Completion: 2016-06-30
• First posted: 2012-12-20
• Last updated: 2017-03-07

Locations

4 sites across 3 countries: United States, Belgium, Italy