Introduction

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) was not always technically feasible. The distance between the gallbladder (GB) and the gastrointestinal wall and the GB distension were some of the limiting factors to the EUS-GBD.

Aims & Methods

Our study aim was to evaluate abdomen computed tomography (CT) predictors of EUS-GBD technical success (TS).
The CT images of all consecutive patients that underwent EUS-GBD from January 2020 to December 2022 in our hospital were retrospectively evaluated.
CT data collected were: artifacts presence, days between CT and EUS-GBD, slice thickness, region of interest (ROI) density, GB morphology, GB long and short axis, sludge, stones presence, size, location and density, distance between GB and antrum or duodenal bulb, GB wall thickness and peri-GB fluid presence.
EUS-GBD data evaluated were: type and size of stent, TS and clinical success.

Results

We evaluated 45 abdomen CTs of patients that underwent EUS-GBD (male 60%, mean age 81.3±10.5 years old).
The mean time between CT and EUS-GBD was 4±4 days. EUS-GBD was performed via duodenal bulb in 29 (64.4%) cases.
Mean GB short and long axis length were 42.1±11.4 and 103.4±28.7 mm, respectively.
Mean CT distance between GB and stomach or duodenal bulb were 14.8±12.9 and 10.8±10.6 mm, respectively. Stones were found in 22 (48.9%) GB with mean size of 14.9±4.5 mm. Sludge was described in 23 (51.1%) cases. On univariate analysis, CT distance between GB and duodenal bulb, GB wall thickness and GB short axis length were significantly related to EUS-GB TS, but only CT distance between GB and duodenal bulb and GB wall thickness were an independent predictor of EUS-GBD TS at multivariate analysis.

Conclusion

Pre-EUS-GBD CT may be a useful tool to predict EUS-GBD TS, especially the TC measurement of the distance between the GB and the duodenal bulb and GB wall thickness.

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

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

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

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 biliary drainage (EUS – BD) has become widely accepted over the past several years for complicated biliary drainage when conventional endoscopic retrograde cholagiopancreatography is not successful or feasible due to variety of constrains. The success rate of the procedure is between 90% an 97% and the complication rate is less than 10%.

Aims & Methods

The aim of the study is to evaluate the safety and efficacy of EUS-BD performed in our unit while assessing the risk factors associated with the procedure.
We performed retrospective analysis of a prospective data base from March 2020 to October 2023. The patients underwent EUS – BD using linear scope (Fujifilm EG – 580UT). Several procedures are possible. The procedure was tailored to individual patient’s anatomy.

Results

We identified 140 patients who underwent EUS-BD during the study period ( men- 75, women- 65) – 130 (92.8%) with malignant and 10 (7.1%) with benign disease. Gender distribution shows higher rate of postprocedural complications in men ( 29,7% vs 21,5%), nevertheless there is no statistically significant correlation between gender and complication rate. The medium age of the patients was 66.3 years (38 years – 92 years). No statistically significant correlation was found between age, presence of arterial hypertension, diabetes mellitus and adverse events.
We analyzed the different therapeutic modalities including EUS - CDS (n = 20), EUS - HGS (n = 88), antegrade stenting (n = 12) and rendezvous (n = 13), hepaticojejunostomy (n = 5), cholecystogastrostomy and -duodenostomy (n = 2). We found no statistically significant correlation between the type of technical modality and the incidence of peri- and post-procedural complications.
The technical success was 96.6% (n = 137). Mean duration of the procedure was 42.15 min. (10 min. – 170min.). Mean hospital stay was 5 days (2 days – 10 days ). Adverse events were detected in 38 patients (27.1%). The various complications that have been reported were classified into periprocedural and postprocedural:

• Periprocedural adverse events were detected in 7 (5%) patients: 2 (1.4%) with bleeding, 2 (1.4%) with stent migration, 3 (2,1%) with loss of access.
• Postprocedural complications are deteced in 29 (20,7%) and we divided into:

1. Early (up to 7 days after procedure) – n = 21 (15%) of them 13 (9,3%) with cholangitis, 3 (2,1%) with abdominal pain, 1 (0,7%) with bleeding, 2 (1,4%) with pancreatitis, 1 (0,7%) with pneumoperitoneum and 1 (0,7%) patient with biloma.
2. Late (a week after the procedure) – n = 8 (5,7%) with cholangitis.

• There were 2 deaths related to the procedure (1.4%) in patients with advanced oncologic disease.

Conclusion

EUS-BD is effective tool for biliary drainage both in naïve patients and those with altered biliary anatomy. Along with the possibility of emergency PTBD, it has favourable technical and clinical success rate and safety profile and therefore the potential to shift the current paradigms that define management of complicated biliary obstruction.

References

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Disclosure

Also presented on ESGE DAYS 2024