Open label randomized, multicentre, controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.
- Conditions
- Pancreatic exocrine insufficiencyMedDRA version: 20.0Level: LLTClassification code: 10073392Term: Pancreatic exocrine insufficiency Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Patients older than 18 years, any gender, fulfilling all the following criteria will be considered for enrolment into the study, Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer., Tumour located in the head of the pancreas, Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS), Significant weight loss (=5% of the usual body weight) at screening, Life expectancy of at least six months at screening, Signed informed consent to the study
Hypersensitivity to pancreatin of porcine origin or to any of the excipients, Inability to comply with the study visits and study protocol, whatever the reason, Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned, Patients already on PERT, Prior history of upper gastrointestinal or pancreatic surgery, Short life expectancy (shorter than 6 months), Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy), Patients in whom a pancreatic stent has been placed, Unsolved gastric outlet obstruction, Unwillingness to participate in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method