A prospective, descriptive cohort study evaluating the prevalence and incidence of exocrine pancreatic insufficiency in patients with pancreatic cancer.

A prospective, descriptive cohort study evaluating the prevalence and incidence of exocrine pancreatic insufficiency in patients with pancreatic cancer. - Prevalence, incidence of EPI in pancreaticcancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35011

Enrollment

Registered

2010-01-25

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic exocrine insufficiency

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who are considered for this trial: - Age >= 18 years. - Malignant tumours of the pancreas, distal cholangiocarcinoma and papillary tumours proven by means of cytology/histology and/or radiology. - are capable and willing to follow instructions given by the physician.

Exclusion criteria

Exclusion criteria: The following are considered as exclusion criteria: - Subjects who are unwilling or unable to understand and participate in the study and sign the informed consent. - Pre-existent EPI - Pre-existent malabsorption (short bowel disease, IBD, other) - Any known gastro-intestinal disease or major gastrointestinal surgery that could potentially affect the intestinal absorption or metabolism of fat - Total pancreatectomy - Gastroparesis - Pregnancy/lactation - Patients who are suspected not to be reliable in participating in this study, based on the physicians experience.

Design outcomes

Primary

Measure	Time frame
The incidence of EPI in pancreatic cancer: EPI is defined as a FET	—

Secondary

Measure	Time frame
What is the predictive value of different disease characteristics during the development of EPI? o tumour localisation (pancreas, distal cholangiocarcinoma and papillary tumours) o tumour size o metastases (metastases in solid organs: liver and lungs and/or lymph noduli >1 cm in size) o vascular tumour infiltration o tumour resectability o different operative techniques o steatorrhea related symptoms (stool frequency and consistency, stomach aches and/or flatulence, sticky stool) o weight loss (BMI) o presence of jaundice o presence of diabetes mellitus during disease process o the presence of nutritional deficiencies o subjective pain-score (1-10) o doses of pain medication	—

Measure

Time frame

What is the predictive value of different disease characteristics during the development of EPI? o tumour localisation (pancreas, distal cholangiocarcinoma and papillary tumours) o tumour size o metastases (metastases in solid organs: liver and lungs and/or lymph noduli >1 cm in size) o vascular tumour infiltration o tumour resectability o different operative techniques o steatorrhea related symptoms (stool frequency and consistency, stomach aches and/or flatulence, sticky stool) o weight loss (BMI) o presence of jaundice o presence of diabetes mellitus during disease process o the presence of nutritional deficiencies o subjective pain-score (1-10) o doses of pain medication

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Countries

Netherlands

Outcome results