Pancreatic Juice Diagnosis From Duodenum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01699698
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : September 3, 2015
Last Update Posted : September 21, 2015
Mayo Clinic
Kyushu University
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Olympus Corporation

Brief Summary:
Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Other: Tumor markers Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Pancreatic Juice Diagnosis From Duodenum
Study Start Date : October 2012
Actual Primary Completion Date : July 2014

Arm Intervention/treatment
Experimental: Test subject 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.

Primary Outcome Measures :
  1. The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort [ Time Frame: 1year ]

    We hypothesized that there is a statistically-significant difference between two cohorts.

    The cancer marker is S100P.

Secondary Outcome Measures :
  1. The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants. [ Time Frame: 1 year ]
    Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01699698

United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Kyushu University
Fukuoka-shi, Fukuoka-ken, Japan
Sponsors and Collaborators
Olympus Corporation
Mayo Clinic
Kyushu University
The University of Texas Health Science Center, Houston
Principal Investigator: Massimo Raimondo, M.D. Mayo Clinic

Responsible Party: Olympus Corporation Identifier: NCT01699698     History of Changes
Other Study ID Numbers: OMSC-PJD-1
First Posted: October 4, 2012    Key Record Dates
Results First Posted: September 3, 2015
Last Update Posted: September 21, 2015
Last Verified: September 2015

Keywords provided by Olympus Corporation:
Pancreatic adenocarcinoma

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type