Biliary Tract Neoplasms, Malignant Biliary Obstruction, Pancreatic Cancer
Conditions
Keywords
Choledochoduodenostomy, Therapeutic endoscopy, Biliary Drainage, Lumen apposing metal stent, ERCP, Biliopancreatic malignancy
Brief summary
The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.
Detailed description
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in potentially surgical patients is still limited. Recent retrospective study (Janet J et al, Ann Surg Oncol 2023) and two recent meta-analysis (Barbosa E et al, GIE 2024; Gopakumar H et al, AM J Gastr 2024; both with \> 500 cases) found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate. Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates (technical failure, postprocedure pancreatitis) when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease.
Interventions
PROCEDUREEndoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
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) 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.
Sponsors
Hospital Universitari de Bellvitge
Hospital Mutua de Terrassa
Hospital Clínico Universitario de Valencia
Hospital General Universitario de Alicante
Hospital General Universitario de Castellón
Complejo Hospitalario Universitario de Santiago
University Hospital Virgen de las Nieves
Complejo Hospitalario de Navarra
Hospital de Sant Pau
University of Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprocedure surgical challenges rate | 1 day to 24 months | Percentage of biliary drainage technical failure and/or percentage of postprocedure acute pancreatitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | 14 days after BD | In jaundice: decreasing \> 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure. |
| AE - biliary drainage | 0 to 30 days after BD | Adverse events rate related to biliary drainage according to the AGREE classification |
| AE - surgery | 0 to 90 days after surgery | Adverse events rate related to surgery according to the Claiven and Dindo classification. |
| Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP) | 1 day to 6 months | Number of days between intervention (T1-biliary drainage) and surgery |
| Rate of surgery | 1 to 24 months | Rate of patients that undergo to surgery |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORJoan B Gornals, PhD
Hospital Universitari de Bellvitge, SEED
Outcome results
None listed