EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Apr 18, 2024

Keywords

ClinConnect Summary

The CARPEDIEM-1 Trial is a clinical study that aims to compare two methods for relieving blockages in the bile ducts caused by cancer. The researchers want to find out whether using an EUS-guided choledochoduodenostomy (a procedure that creates a new pathway for bile to flow) or an ERCP (a common procedure to remove blockages) is more effective in getting patients ready for surgery. They will look at how long it takes for patients to receive treatment and then have surgery after experiencing a blockage.

To be eligible for this study, patients must have a type of bile duct blockage that doctors believe can be surgically removed. They should also have specific signs of bile duct obstruction and be able to understand and agree to participate in the study. Unfortunately, certain conditions, like pregnancy or severe bleeding disorders, would exclude someone from joining. Participants will be closely monitored, and they can expect to undergo follow-up tests throughout the study. This trial is not yet recruiting participants, but it represents an important step in improving treatment options for patients with biliary obstructions due to cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE 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 borderline, 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.