The i-EUS consensus on EUS-guided gallbladder drainage: A 3-step modified Delphi approach
Facciorusso, Antonio et al. per [i-EUS Working Group]
Abstract
Background and Objective
EUS-guided gallbladder drainage (EUS-GBD) has emerged as a viable alternative for patients with acute cholecystitis who are unfit for surgery. However, standardized guidelines for its indications, techniques, and management remain limited. The objective of this study is to develop evidence-based consensus recommendations for EUS-GBD in benign and malignant conditions, aimed at guiding clinical decision-making and improving patient outcomes.
Methods
A 3-step modified Delphi process was used by the Interventional Endoscopy and Ultrasound Group, involving multidisciplinary experts in gastroenterology, surgery, and radiology. Four task forces conducted systematic literature reviews and generated PICO (Patients, Interventions, Comparator, and Outcomes)–formatted clinical questions. Evidence was graded using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system, and consensus was defined as ≥80% agreement among panelists.
Results
Twenty-two clinical questions were addressed, covering indications, timing, techniques, device selection, procedural aspects, and postprocedural care for EUS-GBD. Recommendations include the preferential use of EUS-GBD over percutaneous and transpapillary approaches in high-risk patients, early intervention in select cases, the use of lumen-apposing metal stents, and tailored postprocedural strategies. All recommendations were conditional, except for one strong recommendation in favor of EUS-GBD over other modalities, supported by moderate-quality evidence.
Conclusions
This consensus offers a comprehensive, multidisciplinary guideline for the safe and effective use of EUS-GBD in clinical practice. These recommendations aim to standardize care and support future research in this rapidly evolving field.
INTRODUCTION
Cholecystectomy remains the gold standard for managing acute cholecystitis (AC). However, in certain patients, particularly those with severe comorbidities or poor surgical candidacy, emergency cholecystectomy may pose significant risks, with morbidity rates reaching up to 41% and increased mortality.[1] When surgical intervention is not feasible, percutaneous gallbladder drainage (PT-GBD) offers an alternative for gallbladder decompression, utilizing ultrasound- or computed tomography–guided placement of a cholecystostomy tube. Although effective, PT-GBD has been associated with notable complications, including bleeding, bile leakage, pneumothorax, secondary infections, patient discomfort, and a risk of accidental catheter dislodgement.[2]
Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic transpapillary GBD (ET-GBD) provides an internal alternative for drainage, eliminating external tube-related complications. However, its success is hindered by technical challenges, particularly in cases of cystic duct obstruction, and a considerable risk of pancreatitis. On the other hand, EUS-guided GBD (EUS-GBD) has emerged as a minimally invasive, safe, and effective therapeutic option, especially with the advent of lumen-apposing metal stents (LAMSs), which have enhanced procedural efficiency and safety.[3,4] This paradigm shift necessitates well-defined evidence regarding the indications, standardization of techniques, and selection of rapidly evolving devices. Implementing novel approaches in routine clinical practice requires rigorous validation and standardization to ensure optimal outcomes.
The Interventional Endoscopy and Ultrasound Group (i-EUS) was established in 2017 as a collaborative network of Italian expert biliopancreatic endoscopists dedicated to data sharing, continuous updates, and education. The group aims to enhance procedural outcomes through methodical evaluation of execution techniques, clinical success, and long-term follow-up. Recognizing the absence of established guidelines in this domain, i-EUS has evolved into a multidisciplinary platform tasked with organizing consensus conferences to define indications, technical considerations, clinical management, and patient follow-up based on the best available evidence. The primary objective of these consensus guidelines is to provide evidence-based recommendations on EUS-GBD for both benign and malignant conditions. The primary audience for this document consists of clinicians involved in the management of patients with gallbladder disease.
