EUS-guided biliary interventions for benign diseases and unsuccessful ERCP – a prospective unicenter feasibility study on a large consecutive patient cohort

Abstract

Background and study aim Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for the treatment of biliary obstruction of any etiology. However, cannulation failure of the common bile duct (CBD) by ERCP occurs in 5–10%. Alternatives after a failed ERCP are re-ERCP by an expert endoscopist, percutaneous transhepatic cholangio drainage (PTCD), (balloon) enteroscopy-assisted ERCP, or surgery. Endoscopic ultrasonography-guided drainage of the bile ducts (EUS-BD) is becoming the standard of care in tertiary referral centers for cases of failed ERCP in patients with malignant obstruction of the CBD. In expert hands, EUS-guided biliary drainage has excellent technical/clinical success rates and lower complication rates compared to PTCD. Despite the successful performance of EUS-BD in malignant cases, its use in benign cases is limited.

The aim of this study (design, systematic prospective clinical observational study on quality assurance in daily clinical practice) was to evaluate the efficacy and safety of EUS-BD in benign indications.

Patients and methods Patients with cholestasis and failed ERCP were recruited from a prospective EUS-BD registry (2004–2020). One hundred and three patients with EUS-BD and benign cholestasis were extracted from the registry (n_Total = 474). Indications of EUS-BDs included surgically altered anatomy (n = 65), atypical bile duct percutaneous transhepatic cholangio orifice at the duodenal junction from the longitudinal to the horizontal segment (n = 1), papilla of Vater not reached due to the gastric outlet/duodenal stenoses (n = 6), papilla that cannot be catheterized (n = 24), and proximal bile duct stenosis (n = 7). The primary endpoint was technical and clinical success. Secondary endpoints were procedure-related complications during the hospital stay.

Results 103 patients with EUS-BD and benign cholestasis were extracted from the registry (nTotal=474). Different transluminal access routes were used to reach the bile ducts: transgastric (n = 72/103); -duodenal (n = 16/103); -jejunal (n = 14/103); combined -duodenal and -gastric (n = 1/103). The technical success rate was 96 % (n = 99) for cholangiography. Drainage was not required in 2 patients; balloon dilatation including stone extraction was sufficient in 17 cases (16.5 %; no additional or prophylactic insertion of a drain). Transluminal drainage was achieved in n = 68/103 (66 %; even higher in patients with drain indication only) by placement of a plastic stent (n = 29), conventional biliary metal stents (n = 24), HotAXIOS stents (n = 5; Boston Scientific, Ratingen, Germany), Hanaro stents (n = 6; Olympus, Hamburg, Germany), HotAXIOS stents and plastic stents (n = 1), HotAXIOS stents and metal stents (n = 1) and metal stents and plastic stents (n = 2). Techniques for stone extraction alone (nSuccessful=17) or stent insertion (nTotal = 85; nSuccessful=85 – rate, 100 %) and final EUS-BD access pathway included: Rendezvous technique (n = 14/85; 16.5 %), antegrade internal drainage (n = 20/85; 23.5 %), choledochointestinostomy (n = 7/85; 8.2 %), antegrade internal and hepaticointestinostomy (n = 22/85; 25.9 %), hepaticointestinostomy (n = 21/85; 24.7 %), choledochointestinostomy and hepaticointestinostomy (n = 1/85; 1.2 %).

The complication rate was 25 % (n = 26) – the spectrum comprised stent dislocation (n = 11), perforation (n = 1), pain (n = 2), hemorrhage (n = 6), biliary ascites/leakage (n = 3) and bilioma/liver abscess (n = 3; major complication rate, n = 12/68 – 17.6 %). Re-interventions were required in 19 patients (24 interventions in total).

Discussion EUS-BD can be considered an elegant and safe alternative to PTCD or reoperation for failed ERCP to achieve the necessary drainage of the biliary system even in underlying benign diseases. An interventional EUS-based internal procedure can resolve cholestasis, avoid PTCD or reoperation, and thus improve quality of life. Due to the often complex (pathological and/or postoperative) anatomy, EUS-BD should only be performed in centers with interventional endoscopy/EUS experience including adequate abdominal surgery and interventional radiology expertise in the background. This enables adequately adapted therapeutic management in the event of challenging complications. It seems appropriate to conduct further studies with larger numbers of cases to systematize the approach and peri-interventional management and to successively develop specific equipment.

Zusammenfassung

Hintergrund und Studienziel Die endoskopische retrograde Cholangiopancreatografie (ERCP) ist der Goldstandard in der Behandlung von Obstruktionen der Gallenwege jedweder Art, Ursache und Genese. In schätzungsweise 5–10 % der Fälle ist sie jedoch nicht erfolgreich hinsichtlich einer Gangkanülierung. Alternative therapeutische Optionen umfassen Re-ERCP durch einen sehr erfahrenen Endoskopiker, die PTCD, Enteroskopie-ERC oder die Operation. Die EUS-geführte Drainage der Gallenwege (EUS-BD) hat sich in spezialisierten Zentren als eine sinnvolle alternative Herangehensweise für Patienten mit malignen Tumorläsionen und Cholestase im palliativen Setting etabliert. In fachmännischer Hand hat die EUS-geführte biliäre Drainage exzellente technische/klinische Erfolgs- und niedrige Komplikationsraten im Vergleich zur PTCD. Trotz der erfolgreichen Anwendung der EUS-BD bei Malignität, wird sie bisher nur begrenzt für benigne Fälle genutzt.

Das Ziel der Arbeit (Design: systematisch prospektive klinische Observationsstudie zur Qualitätssicherung in der täglichen klinischen Praxis) ist die Untersuchung von Effektivität und Sicherheit der EUS-BD bei benignen Indikationen.

Patienten und Methoden Patienten mit Cholestase und nicht erfolgreicher ERCP wurden aus einem prospektiven EUS-BD-Register (2004-2020) rekrutiert. Indikationen für die EUS-BDs schlossen ein: biliodigestive Anastomose (n = 45), Gastrektomie (n = 9), subtotale Gastrektomie (n = 5), Magenresektion nach Billroth-II (n = 6), atypische Gallengangsmündung am Übergang vom longitudinalen zum horizontalen Segment (n = 1), nicht erreichte/identifizierbare Papilla Vateri (n = 24), segmentale Cholestase nach LTx (n = 1) und andere Indikationen (n = 5). Primärer Endpunkt war der technische und klinische Erfolg. Sekundärer Endpunkt waren Prozedur-bezogene Komplikationen während das Krankenhausaufenthaltes.

Ergebnisse Insgesamt wurden 103 Patienten mit einer EUS-BD und benigner Cholestasis aus dem Register extrahiert (n _Total=474). Es wurden verschiedene transluminale Zugangswege genutzt, um die Gallenwege zu erreichen: transgastrisch (n = 72/103); -duodenal (n = 16/103); kombiniert -duodenal und -gastrisch (n = 1/103). Die technische Erfolgsrate lag bei 96 % (n = 99) für die Cholangiographie. Die Drainage war bei 2 Patienten nicht erforderlich; die Ballondilatation inklusive Steinextraktion war in 17 Fällen ausreichend (16,5 %; keine zusätzliche oder prophylaktische Einlage einer Drainage). Die transluminale Drainage wurde in n = 68/103 (66 %; sogar noch höher bei Patienten mit ausschließlicher Drainageindikation) durch Platzierung eines Plastikstents (n = 29), herkömmlichen biliären Metallstents (n = 24), HotAxios-Stents (n = 5; Boston Scientific, Ratingen, Germany), Hanaro-Stents (n = 6; Olympus, Hamburg, Germany), HotAxios-Stents und Plastikstents (n = 1), HotAxios-Stents und Metallstents (n = 1) sowie Metallstents und Plastikstents (n = 2) erreicht.

Die Techniken für die Steinextraktion allein (n _erfolgreich=17) oder Stentinsertion (n _Total = 85; n _erfolgreich=85 – rate, 100 %) und den endgültigen EUS-BD-Zugangsweg beinhalten: Rendezvoustechnik (n = 14/85; 16,5 %), antegrade interne Drainage (n = 20/85; 23,5 %), Choledochointestinostomie (n = 7/85; 8,2 %), antegrade interne und Hepaticointestinostomie (n = 22/85; 25,9 %), Hepaticointestinostomie (n = 21/85; 24,7 %), Choledochointestinostomie und Hepaticointestinostomie (n = 1/85; 1,2 %).

Die Komplikationsrate betrug 25 % (n = 26). Das Komplikationsspektrum (n = 26/25 %) wurde durch Stentdislokation (n = 11), Perforation (n = 1), Schmerz (n = 2), Blutung (n = 6), Bilaskos/Leckage (n = 3) und Biliom/Leberabszess (n = 3) bestimmt (Majorkomplikationsrate: n = 12/68 – 17,6 %). Re-Interventionen waren bei 19 Patienten (insgesamt 24 Interventionen) erforderlich.

Diskussion Die EUS-BD kann als eine elegante und sichere Alternative zur PTCD oder Reoperation bei frustraner ERCP angesehen werden, um die notwendige Drainage der Gallenwege auch bei benignen Grunderkrankungen zu erreichen. Durch eine interventionelle EUS-basierte interne Prozedur kann die Cholestase behoben, eine PTCD oder Reoperation vermieden und somit eine verbesserte Lebensqualität erreicht werden. Wegen der häufig komplexen (pathologischen und/oder postoperativen) Anatomie sollte die EUS-BD nur in Zentren mit interventioneller Endoskopie/EUS Erfahrung inklusive einer adäquaten viszeralchirurgischen und interventionell-radiologischen Expertise im Hintergrund durchgeführt werden. Dies ermöglicht beim Auftreten von herausfordernden Komplikationen ein adäquates angepasstes therapeutisches Management. Es erscheint angezeigt, weiterführende Studien mit größeren Fallzahlen durchzuführen, um das Herangehen und das periinterventionelle Management zu systematisieren und sukzessive ein spezifisches Equipment zu entwickeln.

Schlüsselwörter

EUS-geführte transluminale Drainage der Gallenwege (EUS-BD) - Cholestase - benigne Gallenwegserkrankung - ERCP - konsekutive Unicenter-Patientenkohorte - systematische prospektive klinische Beobachtungsstudie - Machbarkeit - Qualitätssicherung

Keywords

EUS-guided transluminal drainage of the bile ducts (EUS-BD) - Cholestasis - Benign biliary tract disease - ERCP - Consecutive single-center patient cohort - Systematic prospective clinical observational study - Feasibility - Quality assurance

Publication History

Received: 25 January 2021

Accepted after revision: 25 June 2021

Article published online:
10 September 2021

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