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 2023, EUS-GBD with the novel drainage kit was performed on 38 live pigs. In six 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 four cases, the anchors and drainage tube were endoscopically removed just before LC. In two 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 will verify it though clinical trials involving humans in the future.

Introduction

Lumen-apposing metal stents have increasingly been used for acute cholecystitis cases where surgery is not an option. However, endoscopic ultrasound gallbladder drainage (EUS-GBD) is rarely performed in cases where surgery can be safely planned. One reason for this is the large size of the fistula and the spread of inflammation to the cystic duct, which makes surgery difficult. Preoperative EUS-GBD has the potential to reduce hospital stay, alleviate pain, and eliminate the need for external drainage tube management when compared to percutaneous drainage. To address these challenges, we developed a novel drainage kit specifically for EUS-GBD. This kit includes an anchor to fix the gallbladder and gastric walls and a thin drainage tube that allows one-step insertion and washing. This kit is believed to help create a smaller fistula, prevent the spread of inflammation to the cystic duct, and facilitate subsequent surgery. Here, we present the preliminary results of an exploratory clinical study using this novel kit as a first-in-human case.

Aims & Methods

The aim of this study was to evaluate the clinical outcomes of preoperative EUS-GBD using a novel drainage kit.
Between April 2024 and January 2025, EUS-GBD was performed using the novel drainage kit in six cases of acute cholecystitis. These patients were eligible for elective surgery but ineligible for emergency surgery. There were five female patients with a mean age of 70.0 years (range: 55 to 88 years). The mean time from symptom onset to treatment was 2.7 days (range: 1 to 5 days). All patients had gallstones. All cases have undergone laparoscopic cholecystectomy (LapC) at a mean of 36.8 days (range: 32 to 43 days) after EUS-GBD. The technical success rate, clinical success rate, adverse event rate, mean hospital stay, and conversion rate to open surgery were evaluated.

Results

The technical success rate was 100%, and the clinical success rate was also 100%. No adverse events or open surgery occurred. The mean hospital stay after EUS-GBD was 5.3 days (range: 5 to 6 days), and the mean hospital stay after LapC was 5.3 days (range: 5 to 6 days).

Conclusion

Preoperative EUS-GBD using the novel drainage kit was feasible and safe.

Disclosure

Stock ownership: KOEDA Inc.

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

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) 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 ultrasonography–guided rendezvous technique (EUS-RV) has been reported to be useful as a salvage method in cases of difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP). Having said that, needle-knife precut (including transpancreatic sphincterotomy) is often selected over EUS-RV. However, it is associated with adverse events such as retroperitoneal perforation, retroperitonitis, and papillary hemorrhage. On the other hand, EUS-RV has been reported to afford a higher success rate and lower incidence of adverse events. Nevertheless, few studies have compared the effectiveness of EUS-RV and the precut method.

Aims & Methods

To compare the outcomes of EUS-RV and the precut method in cases of difficult cannulation of the common bile duct due to stones.
From January 2018 to September 2022, 735 patients with a naive papilla with common bile duct stones underwent ERCP excluding post-reconstruction intestinal tract (excluding the Billroth-I method). Forty-three patients underwent salvage cannulation. EUS-RV and the precut method were attempted in 14 and 29 cases, respectively. There was no case in which the precut method and EUS-RV were performed in a single session. All patients received standard post-ERCP pancreatitis prophylaxis, and the success rates of the technique, adverse event rates, and procedure time were documented.

Results

The technical success rates of biliary cannulation via EUS-RV and the precut method were 83% and 79%, respectively. The corresponding adverse event rates were 13% and 28%. The adverse events noted were as follows: two cases of posterior hemorrhage and one of pancreatitis in patients who underwent EUS-RV and three cases of pancreatitis and one of posterior hemorrhage among patients in whom the precut method was performed. The median times from starting the usual cannulation technique to the decision to switch to the salvage method were 17 and 20 min, respectively, among patients in whom EUS-RV and precut method were attempted. The corresponding median times from the decision to switch to the salvage method to successful biliary cannulation (or quitting in cases of failure) were 20 and 26 min (p = 0.02).

Conclusion

EUS-RV tended to have a higher success rate and cause fewer adverse events than the precut method. However, the associated procedure time was significantly longer, partly because it included the time required to replace the endoscope twice. The findings suggest that EUS-RV can be an option in cases in which the usual cannulation technique has failed, because the associated technical success and adverse event rates are similar.

References

Mallery, 2004 ;
Kim, 2010 ;
Iwashita, 2012 ;
Dhir, 2013 ;
Kawakubo, 2013

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