NCT01699698

Pancreatic Juice Diagnosis From Duodenum

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (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 juice diagnosis to screen UICC stage II pancreatic ductal 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 standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. The investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility study to confirm clinical performance.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Tumor markers	Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-07-01
• First posted: 2012-10-04
• Last updated: 2015-09-21
• Results posted: 2015-09-03

Locations

2 sites across 2 countries: United States, Japan