Pancreatic Juice Diagnosis From Duodenum

Pancreatic Adenocarcinoma Clinical Trial

Official title:

Pancreatic Juice Diagnosis From Duodenum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699698
• Other study ID #: OMSC-PJD-1
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: September 2, 2015
• Start date: October 2012

Study information

• Verified date: September 2015
• Source: Olympus Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
Japan	Kyushu University	Fukuoka-shi	Fukuoka-ken
United States	Mayo Clinic Jacksonville	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Olympus Corporation	Kyushu University, Mayo Clinic, The University of Texas Health Science Center, Houston

Countries where clinical trial is conducted

United States,  Japan, 

References & Publications (1)

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. Epub 2007 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort	We hypothesized that there is a statistically-significant difference between two cohorts.; The cancer marker is S100P.	1year	No
Secondary	The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.	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.	1 year	No