Status:
UNKNOWN
Impact of Pancreatic Endoscopic Drainage on Exocrine Pancreatic Function in Unresectable Pancreatic Cancer
Lead Sponsor:
Hospital Clinico Universitario de Santiago
Conditions:
Pancreatic Neoplasm Malignant Head Primary
Pancreatic Exocrine Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: exocrine pancreatic insufficiency (IPE), frequent in patients with pancreatic cancer, plays a major role in malnutrition and cachexia with a significant impact on survival, quality of life...
Detailed Description
In a recent study by our group, 13 patients with unresectable pancreatic head cancer and PEI were randomized into 2 groups (biliopancreatic stent versus biliary stent), showing a statistically signifi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05244174
Start Date
January 25 2022
End Date
May 1 2024
Last Update
March 2 2023
Active Locations (1)
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1
Daniel de la Iglesia
Santiago de Compostela, A Coruña, Spain, 15705