Biliary Tract Neoplasms, Malignant Biliary Obstruction, Pancreatic Cancer Non-resectable
Conditions
Keywords
Choledochoduodenostomy, Gallblader drainage, Lumen apposing metal stent, Biliary drainage, Biliopancreatic malignancy
Brief summary
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.
Detailed description
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) with a biliary lumen-apposing metal stent (LAMS) has been widely accepted as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). Recent studies (DRAMBO and ELEMENT trial) compared EUS-CDS vs ERCP as a first line treatment in MDBO in palliative patients, showing similar clinical and techinal success and adverse events rate between both techniques, demonstrating that both procedures could be options for primary biliary drainage in unresectable MDBO. Furthermore a recent clinical trial (BAMPI trial) has proven that the addition of a coaxial double pigtail (DPS) offers benefits in terms of safey and clinical success. In the last years there has been an increasing interest for the EUS-guided gallblader drainage (EUS-GBD) in unresectable MDBO as an alternative for EUS-CDS, and recent studies and reviews have been reported with acceptable techinal and clinical success, but no clinical trial has been performed up to date. Our hypothesis is that EUS-GBD may offer benefits in terms of safety over EUS-CDS, maintaining similar clinical and techinal success rates.
Interventions
PROCEDUREEndoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader. * DPPS size: 7Fr x 3-5-7cm.
Sponsors
Hospital Universitari de Bellvitge
Hospital Clínico Universitario de Valencia
Hospital General Universitario de Alicante
Hospital Mutua de Terrassa
Hospital Universitario Ramon y Cajal
Hospital General Universitario de Castellón
Complejo Hospitalario de Navarra
University Hospital Virgen de las Nieves
Hospital de Sant Pau
University of Salamanca
Complejo Hospitalario Universitario de Santiago
Complejo Hospitalario Universitario de Vigo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RELATED ADVERSE EVENTS | 12 months | Safety will be measured by careful and comparative evaluation of adverse effects in both groups. |
| Patients with Recurrent biliary obstruction | 12 months | Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CLINICAL SUCCESS | 2 weeks | Resolution of jaundice or drop in total bilirubin level by \> 50% within 2 weeks after the EUS guided drainage. |
| TECHNICAL SUCCESS | 24 hours | Technical success was defined as successful placement of the LAMS between the bile duct (choledoc or gallblader) and the lumen digestive system (stomach or duodenum), creating a transmural ostomy. To evaluate the correct position of the transmural stent, the deployment of the internal flap in the lumen of the bile duct must be verified by ultrasound vision and the internal flap by endoscopic vision. |
| BILIARY REINTERVENTIONS (BRI) | 12 months | Interventions needed to treat - Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration. |
| HOSPITAL STAY | 12 months | Length of hospital stay after intervention |
| MORTALITY | 12 months | Overall mortality throughout the study |
| COST ANALYSIS | 12 months | Evaluate the costs between the two types of strategy |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORJoan B Gornals Soler
Study Principal Investigator
PRINCIPAL_INVESTIGATORCarme Loras
Hospital Universitari Mutua de Terrassa
Outcome results
None listed