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Pancreatic Juice Diagnosis From Duodenum

18 Years
Open (Enrolling)
Pancreatic Adenocarcinoma

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Trial Information

Pancreatic Juice Diagnosis From Duodenum

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.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

The concentration of the pancreatic cancer markers of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort

Outcome Description:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Massimo Raimondo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

September 2013

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Pancreatic adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Mayo Clinic Jacksonville Jacksonville, Florida  32224