Clinical trial NCT01699698: Pancreatic Juice Diagnosis From Duodenum
Official title: Pancreatic Juice Diagnosis From Duodenum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic adenocarcinoma
Lead sponsor: Olympus Corporation
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
name: Kyushu University
name: The University of Texas Health Science Center, Houston
First posted: 2012-10-04
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort
timeFrame: 1year
Secondary outcomes:
measure: The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Fukuoka-shi
country: Japan
facility: Kyushu University
state: Fukuoka-ken
Study officials:
affiliation: Mayo Clinic
name: Massimo Raimondo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pungpapong S, Noh KW, Woodward TA, Wallace MB, Al-Haddad M, Raimondo M. Endoscopic ultrasound and IL-8 in pancreatic juice to diagnose chronic pancreatitis. Pancreatology. 2007;7(5-6):491-6. doi: 10.1159/000108966. Epub 2007 Oct 1.