Impact of Pancreatic Endoscopic Drainage on Exocrine Pancreatic Function in Unresectable Pancreatic Cancer (DEPARA)
Pancreatic Neoplasm Malignant Head Primary, Pancreatic Exocrine Insufficiency
About this trial
This is an interventional treatment trial for Pancreatic Neoplasm Malignant Head Primary focused on measuring pancreas cancer, ERCP, pancreatic exocrine insufficiency, pancreatic stent
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Histological diagnosis of PDAC
- Radiological diagnosis of the advanced stage not suitable for upfront surgical resection (either locally advanced or metastatic)
- Endoscopic biliary drainage required due to obstructive jaundice
- A written consent to participate in the study
Exclusion Criteria:
- Known history of chronic pancreatitis
- Any contraindication for ERCP under deep sedation or impossibility of biliary cannulation.
- Inclusion in a clinical trial 4 weeks before this study.
- Poor performance status (Eastern Cooperative Oncology Group scale (ECOG) =4)
- Known history of gastrointestinal or pancreatic surgery that is associated with alteration of -pancreatic function.
- Known history of chronic bowel disease (inflammatory bowel disease) that could be associated with nutrient malabsorption
- Gastrointestinal obstruction caused by tumor.
- Pregnancy or breastfeeding
- Unwillingness or inability to understand the study and sign the consent.
Sites / Locations
- Daniel de la IglesiaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Biliary stent
Biliary and pancreatic stent
Biliary stent by ERCP is indicated both in palliative treatment, because of biliary duct decompression improves patient comfort by decreasing itching and jaundice, as in the treatment of the disease itself, because of it lets reach non-toxic levels of bilirubin which is necessary for chemotherapeutic treatment.
During ERCP, the cannulation of the main pancreatic duct may be performed for the placement of a pancreatic duct stent, which is performed routinely as a prophylaxis of post-ERCP acute pancreatitis in patients at risk. In patients with pancreatic cancer, the placement of a pancreatic stent could improve pancreatic secretion by clearing the main pancreatic duct and thus it could improve fat digestion and nutritional status of patients, avoiding the need for PERT