Phase
Condition
Gall Bladder Cancer
Digestive System Neoplasms
Treatment
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
Endoscopic biliary drainage
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Malignant distal biliary obstruction diagnosed in patient considered PALIATIVE withbiliary drainage indication.
Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histologicalconfirmation 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 teststhroughout its duration
Exclusion
Exclusion Criteria:
Pregnancy or lactation.
Severe coagulation disorder: INR > 1.5 non correctable with plasma administrationand/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 proximallyor 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 papillaryaccess ______________ (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., esophagealstricture).
Patients with functional diversity, who lack the capacity to understand the natureand potential consequences of the study, except when a legal representative isavailable.
Patients incapable of maintaining follow-up appointments (lack of adherence).
Lack of informed consent.
Study Design
Study Description
Connect with a study center
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona 08907
SpainActive - Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet De Llobregat, Barcelona, Catalonia 08907
SpainSite Not Available
Hospital General Alicante
Alicante, Valencia
SpainSite Not Available
Hospital Universitari de Castello
Castello, Valencia
SpainSite Not Available
Hospital Santa Creu I Sant Pau
Barcelona,
SpainSite Not Available
Hospital Virgen de Las Nieves
Granada,
SpainSite Not Available
Complejo Hospitalario de Pamplona
Pamplona,
SpainSite Not Available
Hospital Santiago de Compostela
Santiago De Compostela,
SpainSite Not Available
Hospital Mutua de Terrassa
Terrassa,
SpainSite Not Available
Hospital Clinic de Valencia
Valencia,
SpainSite Not Available
Hospital Cunqueiro de Vigo
Vigo,
SpainSite Not Available
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