Pancreatic Juice Diagnosis From Duodenum

NCT ID: NCT01699698

Last Updated: 2015-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31

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.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Test subject

Group Type: EXPERIMENTAL

Tumor markers

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Kyushu University

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

Olympus Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Raimondo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Kyushu University

Fukuoka, Fukuoka, Japan

Countries

United States; Japan

References

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.

Reference Type: BACKGROUND

PMID: 17912013 (View on PubMed)

Other Identifiers

OMSC-PJD-1

Identifier Type: -

Identifier Source: org_study_id