Introduction

Emergent cholecystectomy is recommended for acute cholecystitis (AC). However, cholecystectomy is occasionally difficult in high-risk surgical patients with any comorbidities. Therefore, endoscopic gallbladder drainage is a promising alternative to cholecystostomy. There are two methods for endoscopic gallbladder drainage as follows: endoscopic gallbladder stenting (EGBS) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). However, there are limited data comparing the clinical outcomes of treatment with EGBS and EUS-GBD.

Aims & Methods

This study aims to compare the efficacy and safety of EGBS and EUS-GBD in high-risk surgical patients with AC. We retrospectively reviewed high-risk surgical patients with AC who underwent EGBS or EUS-GBD between April 2012 and March 2022 at two centers. 41 patients (22 men and 19 women; mean age, 82±8 years) underwent EGBS, and 13 patients (6 men and 7 women; mean age, 83±8 years) underwent EUS-GBD. The primary endpoints were technical and clinical success for both methods of endoscopic gallbladder drainage. The secondary endpoints were the rate of recurrent cholecystitis and adverse events (AEs).

Results

The technical success rates in the EGBS group and the EUS-GBD group were 93% (38/41) and 100% (13/13), respectively (p = 0.32). The conversion of EGBS to percutaneous transhepatic gallbladder drainage or EUS-GBD was performed in three patients. The clinical success rates in the EGBS group and the EUS-GBD group were 100% (38/38) and 92% (12/13), respectively (p = 0.08). The median stent patency durations in clinically successful cases in the EGBS group and the EUS-GBD group were 597 days (range, 28-2251 days) and 345 days (range, 36-907 days), respectively (p = 0.377). The recurrence rate in the EGBS group was 21% (8/41; cholecystitis in 3 cases and cholangitis in 5 cases) with the successful management of these eight cases by endoscopic re-intervention, while the recurrence rate in the EUS-GBD group was 0% (0/13). AEs in the EGBS group and the EUS-GBD group were 10% (4/41; mild pancreatitis in 3 cases and cystic duct injury in 1 case) and 8% (1/13; suffocation due to aspiration), respectively (p = 0.82).

Conclusion

Both EGBS and EUS-GBD were useful as permanent drainage in high-risk surgical patients with AC, although there was a tendency that patients treated with EGBS had a higher recurrence rate of cholecystitis than those treated with EUS-GBD.

Disclosure

All authors declare that they have no conflict of interest.

Introduction

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has emerged as a minimally invasive alternative to percutaneous drainage for high-risk surgical patients with acute cholecystitis. Although EUS-GBD is gaining traction in clinical practice, real-world data in complex and high-risk patients remain scarce, particularly regarding outcomes in perforated or malignant cases. While its efficacy is increasingly recognized, data on predictors of success and complications remain limited.

Aims & Methods

This retrospective study explored potential clinical and procedural factors associated with outcomes following EUS-GBD. Patients undergoing EUS-GBD for acute cholecystitis between October 2021 and January 2024 at a tertiary center were included. All procedures were performed by endoscopists with advanced training in interventional EUS. Data on demographics, comorbidities, procedural details, and outcomes were collected. Clinical success was defined as resolution of sepsis or cholecystitis symptoms within 48 hours. Complications included bile leak, infection, and the need for reintervention. Due to the limited sample size, statistical analysis was descriptive and exploratory.

Results

Thirteen patients (6 females, median age 69.1 years [IQR 45–90]) underwent EUS-GBD during the study period. Indications included gallstones (53.8%), malignant cystic duct obstruction (38.4%), and ischemia (7.7%). Reasons for non-surgical management included terminal malignancy (n=6, 46.2%), coronary artery disease (n=5, 38.5%), cirrhosis with hepatocellular carcinoma (n=1, 7.7%), and the patient’s choice (n=1, 7.7%). Lumen-apposing metal stents (LAMS) were placed transgastrically in 10 patients (n=10, 77%) and transduodenally in 3 (n=3, 23%).
Two patients (15.4%) presented with gallbladder perforation and pericholecystic abscess at the time of EUS-GBD. Both cases achieved full resolution following the drainage procedure, indicating that EUS-GBD may serve as a valuable rescue therapy in complicated acute cholecystitis.
Clinical success was achieved in 12 out of 13 patients (92.3%). One patient (7.7%) developed a bile leak, associated with the presence of ascites and hepatocellular carcinoma. Median post-procedural hospital stay was 6.8 days (IQR 3–20). Exploratory analysis suggested a trend toward higher complication rates in patients with ascites and those undergoing transgastric drainage, though no definitive conclusions could be drawn. At 30-day follow-up, no late adverse events or stent-related complications were reported.

Conclusion

EUS-GBD is a highly effective and safe treatment option for acute cholecystitis in patients unfit for surgery, with rapid symptom resolution and acceptable hospital stay duration. Notably, the resolution of pericholecystic abscesses in two cases of gallbladder perforation suggests that EUS-GBD may be beneficial even in more complex clinical scenarios. Preliminary data from this small cohort suggest that the presence of ascites and transgastric access may increase the risk of adverse events. These findings support the role of EUS-GBD not only as a safe alternative in high-risk patients but also as a potentially definitive solution in anatomically and clinically challenging cases. Further prospective studies with more significant patient populations are warranted to validate these early observations and optimize outcomes in this vulnerable population.

Introduction

Laparoscopic cholecystectomy (LC) remains the standard treatment for acute cholecystitis; however, it is not always suitable for patients who are poor candidates for surgery. Moreover, the rate of complications is approximately 10-30% and the mortality rate is approximately 1-2 %, which is not low. Percutaneous transhepatic gallbladder drainage (PTGBD) is recommended as conservative treatment, but the average hospital stay for PTGBD is considerably longer than that for LC especially in Japan. Recently, endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been reported as an alternative treatment for inoperable cholecystitis. However, it has rarely been reported as a preoperative gallbladder drainage because the stent is commonly placed between the gallbladder and duodenum. We have developed an EUS-GBD kit for preoperative gallbladder drainage and have verified the function of it in live pigs for clinical introduction. This kit consists of anchors to fix between the gallbladder and stomach walls and the drainage tube.

Aims & Methods

The purpose of this study is to investigate the feasibility of LC after EUS-GBD with our novel drainage kit. Between May 2019 and March 2024, EUS-GBD with the novel drainage kit was performed on 52 live pigs. In twelve of them, LC was performed 2-9 weeks after EUS-GBD. We investigated the feasibility of LC, the rate of conversion to open cholecystectomy, and the complications.

Results

LC was successfully performed in all cases. In seven cases, the anchors and drainage tube were endoscopically removed just before LC. In five cases, they were not removed before LC, and the gallbladder was removed along with the fistula including a part of the stomach. In all cases, there were no conversion to open cholecystectomy and no complications.

Conclusion

Laparoscopic cholecystectomy after EUS-GBD using our novel drainage kit is feasible in live pigs, and we are currently verifying it though clinical trials involving humans.

Disclosure

I hold a 71% ownership stake in KOEDA Inc.

Introduction

EUS-guided Gallbladder Drainage (EUS-GBD) with Lumen Apposing Metal Stent (LAMS) is a standard treatment for management of acute cholecystitis (AC) in unfit-for-surgery patients. Gallbladder Perforation is standardly considered as a contraindication to EUS-GBD.

Aims & Methods

This series aims at exploring outcomes of EUS-GBD in patients with AC and contained perforation (cp-AC).
All consecutive patients undergoing EUS-GBD in a single tertiary institution between 2020 and 2024 were enrolled in a prospective registry (PROTECT, ClinicalTrials.gov NCT04813055). Patients with cp-AC were included in this series, when presenting gallbladder wall rupture with adjacent encapsulated fluid collections. Baseline demographics and technical details were registered together with Technical success, Clinical success, Adverse Events (AEs), Recurrence and Survival evaluated every 60 days.

Results

From a prospective cohort of 48 EUS-GBD, 19 patients presented with cp-AC (median age 71 [62-78], male 42.1%, Charlson Comorbidity Index of 8 [7-9.8]). Acute cholecystitis was iatrogenic in 79% of these cases (ERCP with metal stenting in 14 and TACE in 1). Reason to avoid surgery was underlying malignancy in 89.5% and comorbidities in 15.8%. Amongst underlying malignancies, the most frequent one was Pancreatic Adenocarcinoma.
Ascites was present in 26.3% of cases. All procedures were performed transduodenally, with an operative luminal space of 31 [25 – 36] mm and a median tract thickness of 6 [5-8] mm.
A 10 mm Hot Axios LAMS was used in 95% of cases, and the release was free-hand in 89% and over-the-wire after former distention in 11% of cases. Antibiotic prophylaxis and coaxial double-pigtail plastic stents were adopted in 95% of cases.
Technical success was 100%. Clinical success was 94.7%, with a statistically significant 7-days reduction of white blood cells (p=0.0017 ) and C Reactive Protein (p=0.0067) .
AEs were registered in 21% of cases, severe/fatal in 11%.
Of note, 2 AEs (1 fatal) were related to additional attempts of draining liver abscesses adjacent to the GBD.
Five patients (27%) underwent additional endoscopic procedures for peroral cholecystoscopy, GBD clearance and LAMS removal, while 2 (11%) patients experienced uneventful LAMS migration.
Median hospital stay was 8 [6-13] days and median time to chemotherapy was 26 [19-56] days for those who were candidate to oncological treatment (N=10).
After a median follow-up of 254 [56-454] days, no AC recurrence was registered.

Conclusion

In the context of AC, contained perforation with adjacent collections does not seem to represent a contraindication to EUS-GBD with LAMS, despite the additional complexity related to a thicker interluminal distance. Management of large adjacent abscesses should involve multidisciplinary management and might require percutaneous drainage.

Introduction

​Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stent (LAMS) has become a favourite drainage option for high surgical-risk patients with acute cholecystitis and as rescue treatment for the relief of jaundice in patients with distal malignant biliary obstruction (DMBO) with high technical and clinical success.
Both trans-gastric and trans-duodenal drainage are described but which is the best way is still controversial.

Aims & Methods

We aim to compare the two different approaches in term of technical success, rate of adverse events, unplanned readmissions and re-interventions.
Single center retrospective analysis of all consecutive cases of EUS-GBD with LAMS acceding to the Therapeutic Endoscopy Unit of Fondazione Policlinico Universitario Campus Bio-Medico of Rome. Data about LAMS features and procedure were collected.

Results

From January 2019 to September 2024 sixty patients were enrolled (50% male; 77±12 years old). The 60% of them underwent EUS-GBD for acute cholecistitis. In 31/60 (52%) patients the trans-gastric access was performed. In 43/60 (71.7%) patients a Hot-Axios LAMS was used and in the majority of procedure (47/60 78.3%) a calibre bigger than 10 mm was used. Overall technical success was obtain in 98.3% of procedures.
In no case the LAMS was dilated. A naso-cistic tube was placed inside the LAMS in 31/60 patients. Double pig-tail plastic stent was placed in two patients. Regarding the adverse events rate, in one patient distal flange misdeployment occurred. LAMS obstruction occurred in 7/60 patients (11.7%) and need of reintervention in 10/60 (16.7%).
There was no difference in term of drainage indication, technical success rate, type and size of LAMS used, naso-cystic tube or pig-tail stent insertion between the two different EUS-GBD access. However, the trans-gastric access was associated with a higher rate of LAMS obstruction (6/7 vs 1/7 p 0.05) and need of re-intervention (8/10 vs 2/10 p 0.03).

Conclusion

EUS-GBD is a safe technique with high technical success rate. Both trans-gastric and trans-duodenal approaches are effective. However, EUS-GBD with trans-gastric access seems to be associated with a higher rate of late adverse events and when possible another way should be preferred.

Introduction

Endoscopic ultrasound-guided gallbladder drainage is usually reserved for high surgical risk patients. The procedure was usually performed under deep sedation to ensure the best tolerability for the patient and facilitate the endoscopist’s performance.
However, many of them showed a high-risk even for deep sedation.

Aims & Methods

Our aim was to evaluate the safety and efficacy of EUS-GBD under conscious sedation (CS).
All consecutive EUS-GBD under CS performed in our hospital were prospectively enrolled from January 2020 to December 2022.
Patient characteristics, type and dosage of anesthetic drug administered (Fentanyl (FNT), Pethidine (PTD) or Benzodiazepine (BZD)), size of lumen-apposing-metal-stent (LAMS), gallbladder (GB) access, technical success, clinical success, early and late adverse events (AEs) rate were evaluated. Safety was defined as AEs occurrence. The efficacy of EUS-GBD was expressed as technical and clinical success. We defined as “conscious sedation” a drug-induced depression of consciousness during which patients respond to verbal commands or react to touch. Breathing remains intact and no support is needed.

Results

A total of 49 patients (41.7% male, mean age 82,9±10 years-old) underwent EUS-GBD under in our Unit. Among all the 49 EUS-GBD in CS, 47 (95.9%) were indicated as treatment for acute cholecystitis in high-surgical-risk patients and 2 (4.1%) as rescue-strategy after ERCP fail.
In 45 (91.8%) EUS-GBD a 10x10mm LAMS was deployed, in 3 (6.2%) procedures a 15x10mm and in 1 (2%) an 8x8mm LAMS. GB was accessed from the duodenum in 68.8% of cases.
A combination of PTD+BZD was administered in 29 (59.2%) EUS-GBD, while 18 (36.7%) procedures were performed under FNT+BZD. Only 2 (4.1%) EUS-GBD were performed only under BZD.
Mean FNT, PTD, BZD dose were 50(±11.5) mcg, 38.4(±25.6) mg and 4(±1.5) mg, respectively.
Technical success of EUS-GBD under CS was 97.9%. In one procedure the distal flange of the LAMS did not open due to LAMS malfunction. The clinical success of EUS-GBD under CS was 97.9% since in one procedure there was not a decrease of inflammatory, cytolysis and cholestasis indices. Only in 1 (2%) EUS-GBD an early AE was reported. No late AEs were described.
The statistical analysis showed that the administration of a combination of fentanyl and benzodiazepine or a combination of pethidine and benzodiazepines or the administration of only benzodiazepines affected neither technical nor clinical success, nor AEs rate (Table 1).

Conclusion

EUS-GBD under CS was a safe procedure with a low AEs rate.
The administration of FNT+BZD, PTD+BZD or BZD alone did not affect procedure outcome.

Introduction

Management of acute cholecystitis in high-risk surgical candidates presents a clinical challenge. Percutaneous drainage via a cholecystostomy tube has been the preferred alternative in this cohort, with high rates of complications and low patient acceptability. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has been proposed as an alternative. Although several prospective studies and one randomised control trial have been published, it is not current standard of practice and there remains some concerns regarding its safety and efficacy.

Aims & Methods

This study evaluates the efficacy and safety of EUS-GBD for non-surgical candidates presenting with acute cholecystitis in the largest prospective cohort at a tertiary hospital within Australia and New Zealand. From July 2024, prospectively collected cases who underwent EUS-GBD using LAMS were entered into a secure database at our institution. Patients were followed for up to 180 days after index EUS-GBD procedure. Primary outcomes included technical and clinical success. Secondary outcomes include adverse events (AE), re-intervention rates and mortality.

Results

Twenty four patients (12 females, 12 males; mean age 75.5 years; range: 54–90) were included from July 2024 to April 2025. Patients were comorbid (mean Charlson Comorbidity Index 5.1), frail (mean Clinical Frailty Scale 4), and had high peri-operative risk (mean ASA score 3). EUS-GBD was technically and clinically successful in 100% of cases. Two (8.33%) patients experienced adverse events (stent occlusion requiring reinterventions). One (4.15%) patient developed atrial fibrillation driven by underlying sepsis necessitating admission to the high-dependency unit following EUS-GBD. There was one death occurring 23 days following EUS-GBD, deemed unrelated to the procedure. There were no procedure related mortality during the study period with an average follow up of 155 days.

Conclusion

Our study demonstrates that EUS-GBD is an effective and safe management option for gallbladder drainage in non-surgical candidates with acute cholecystitis. The high technical and clinical success rates, coupled with few procedure-related complications, support its use as the preferred option for drainage in otherwise poor surgical candidates due to significant medical comorbidities. However, larger studies are needed to validate these findings.

Disclosure

Drs Weilert, Chin and Prof. Fockens - consultants for Boston Scientific