EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

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.

Sex

All

Minimum age

18 Years

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.

• RESULTTeoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, Van der Merwe S, Jacques J, Legros R, Thawee RE, Saxena P, Aerts M, Archibugi L, Chan SM, Fumex F, Kaffes AJ, Ma MTW, Messaoudi N, Rizzatti G, Ng KKC, Ng EKW, Chiu PWY. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-482.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28. PMID 37121331
• RESULTJanet J, Albouys J, Napoleon B, Jacques J, Mathonnet M, Magne J, Fontaine M, de Ponthaud C, Durand Fontanier S, Bardet SSM, Bourdariat R, Sulpice L, Lesurtel M, Legros R, Truant S, Robin F, Prat F, Palazzo M, Schwarz L, Buc E, Sauvanet A, Gaujoux S, Taibi A. Pancreatoduodenectomy Following Preoperative Biliary Drainage Using Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus a Transpapillary Stent: A Multicenter Comparative Cohort Study of the ACHBT-FRENCH-SFED Intergroup. Ann Surg Oncol. 2023 Aug;30(8):5036-5046. doi: 10.1245/s10434-023-13466-8. Epub 2023 Apr 17. PMID 37069476
• RESULTPaik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, Kim DU, Shim JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018 Jul;113(7):987-997. doi: 10.1038/s41395-018-0122-8. Epub 2018 Jul 2. PMID 29961772
• RESULTBang JY, Hawes R, Varadarajulu S. Endoscopic biliary drainage for malignant distal biliary obstruction: Which is better - endoscopic retrograde cholangiopancreatography or endoscopic ultrasound? Dig Endosc. 2022 Jan;34(2):317-324. doi: 10.1111/den.14186. Epub 2021 Nov 29. PMID 34748675