EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Oct 19, 2024

Keywords

ClinConnect Summary

The CARPEDIEM Trial is a clinical study aimed at comparing two different procedures for helping patients with a serious condition called malignant distal biliary obstruction, often related to pancreatic cancer. This obstruction can cause problems like jaundice (yellowing of the skin and eyes) and other liver issues. The trial will look at two methods: EUS-guided choledochoduodenostomy (EUS-CDS) and endoscopic retrograde cholangiopancreatography (ERCP). The goal is to see which method has fewer complications, such as technical failures or acute pancreatitis (inflammation of the pancreas), after the procedure.

To be eligible for this trial, participants must have a specific type of bile duct blockage that is considered either resectable (removable through surgery) or potentially resectable, and they must be able to understand and consent to participate. Key factors for inclusion include having elevated liver enzymes and clear evidence of bile duct obstruction on imaging tests. It’s important to note that some patients, such as those who are pregnant or have certain medical conditions, will not be able to participate. If you join the study, you can expect close monitoring after the procedure to ensure your safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE or POTENTIALLY RESECTABLE/BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
• • Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
• • Patient capable of understanding and/or singning the informed consent.
• • Patient who understands the type of study and will comply with all follow-up tests throughout its duration
• Exclusion Criteria:
• • Pregnancy or lactation.
• • Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3.
• • Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
• • Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
• • Patients with prior biliary stents or other biliary drainages (e.g., PTCD).
• • Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).
• • Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.
• • Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).
• • Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.
• • Patients incapable of maintaining follow-up appointments (lack of adherence).
• • Lack of informed consent.