PanDPI-Study (pancreatic carcinoma) and CoRDPI-Study (colorectal cancer)

Recruiting

Conditions: C25
C18
C20
C78.7
Malignant neoplasm of pancreas
Malignant neoplasm of colon
Malignant neoplasm of rectum
Secondary malignant neoplasm of liver and intrahepatic bile duct

Registration Number: DRKS00031431

Lead Sponsor: Klinik am See

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. curatively (surgically with or without (neo)adjuvant therapy) treated carcinoma of the exocrine pancreas or colorectum.
2. ECOG 0 to 2, or rehablitable.
3. age from 18 years

Exclusion Criteria

1. evidence of metastasis (hepatic or extrahepatic).
2. severe liver parenchymal damage (cirrhosis from Child-Pugh stage A)
3. acute or chronic hepatitis infectious or non-infectious
4. severe (right) heart failure (NYHA III or higher) or evidence of a
congested liver with pulsatility of the portal vein (RI greater than 0.5)
5. portal vein thrombosis, portal vein stenosis (threshold flow velocity 50cm/sec) or
portal hypertension
6. age under 18 years
7. ECOG 3 or 4, or not capable of rehabilitation.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study investigates the association of DPI measured after surgery and (liver) metastasis free survival. The prognostic and predictive values of DPI in relation to the development of hepatic metastasis will be investigated.

Secondary Outcome Measures

Name	Time	Method
1. correlation of DPI and the preoperative and postoperative tumor markers CA 19-9 and CEA, other laboratory values: Alb, protein, BMI, or body surface area <br>2. analysis of the scatter of the measured values (inter-observer problem)