Starting soon
Not applicable
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)
Condition(s) studied
Malignant Biliary ObstructionPancreatic CancerBiliary Tract Neoplasms
Investigational drug(s) / intervention(s)
Endoscopic biliary drainageSelf-expandable metallic stent (SEMS)Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
Endoscopic biliary drainage: Decompression of the bile duct by endoscopic aproach.
Self-expandable metallic stent (SEMS): Self-expandable metallic stent (SEMS) deployment:
* Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
* Size: 10x40mm or 10x60mm or 10x80mm.
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS): Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment:
* LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \> 18mm.
* DPPS size: 7Fr x 3-7cm.
Study summary
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.
Eligibility
Inclusion Criteria:
* Malignant distal biliary obstruction diagnosed in patient considered 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.
Primary outcome measure(s)
- Delay in days between endoscopic biliary drainage and chemotherapy treatment start — 1 day to 12 months
Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.
Trial sites (1)
| Facility | City | Region | Status |
| Hospital Universitari de Bellvitge |
L'Hospitalet de Llobregat |
Barcelona |
|
More Hospital Universitari de Bellvitge trials in Spain
Other trials for the same condition