EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Apr 18, 2024

Keywords

ClinConnect Summary

The CARPEGIEM trial is researching two different methods for treating a serious condition called malignant biliary obstruction, which often occurs in patients with advanced pancreatic cancer and other biliary tract cancers. The study compares the effectiveness and safety of two types of stents—one made of metal and the other of plastic—used in a procedure that helps relieve blockages in the bile duct. The goal is to find out which method works better for patients who are receiving palliative care, which means they are not being treated to cure the disease but to improve their quality of life.

To participate in this trial, patients must have a diagnosed malignant obstruction that requires drainage and be considered palliative. They should be able to understand and sign consent forms and attend follow-up appointments. However, patients who are pregnant, have certain serious health issues, or have had specific prior surgeries may not be eligible. If someone joins the study, they can expect to undergo one of the two procedures and be monitored closely to assess how well it works and if there are any safety concerns. This trial is currently recruiting participants, and it aims to provide valuable information that could help improve care for people facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Malignant distal biliary obstruction diagnosed in patient considered PALIATIVE with biliary drainage indication.
• • 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.
• • Previous cholecistectomy or gallblader perforation.
• • Tumoral obstruction of cystic duct.
• • Multiple liver metastases affecting more than 30% of the liver parenchyma
• • Distal malignant biliary strictures in patients considered resectable or borderline.
• • 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).
• • Gastric outlet obstruction.
• • 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.