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Introduction: It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency.
Objective: The aim is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (CDS-type) for the management of distal malignant biliary obstruction.
Methods: This is a multicentre, open-label, randomised controlled trial with two parallel groups. The primary endpoint was the rate of recurrent biliary obstruction (RBO), as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin >50% within 14days), adverse events, and others.
Results: Between November-2020 and October-2022, 123 patients were screened and 84 with malignant biliary obstruction, and underwent EUS-CDS, were randomised: 44 patients in LAMS group and 40 in LAMS-DPS group. The rate of RBO (31.8 vs12.5%; OR 3.26[IC95% 1.05–10.12], p=0.04) was higher in LAMS group, and procedure time (30 vs 20-min, p=0.02) in DPS-group. Although, more biliary reinterventions (22.7 vs 12.5%, p=0.26) and longer time-to-RBO (51.5 vs 155.5days, p=0.10) were encountered in LAMS group, it was non-significant. AEs were higher in DPS-group (4.5 vs20%, p=0.04). No differences between technical (88 vs 97%) and clinical success (88 vs 92%). NCT04595058 ClinicalTrials.gov.
Conclusions: This trial confirms that CDS with LAMS is an effective technique. The technical strategy of placing a pigtail within the LAMS is associated with a lower risk of RBO, but longer procedure time and related-AEs.

Reference: Garcia-Sumalla A, Loras C, Sanchiz V, et al. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials. 2022; 23: 181.

Figure 2: Primary and secondary outcomes

Figure 2: Primary and secondary outcomes

Figure 1: Demograhics and clinical details

Figure 1: Demograhics and clinical details

Background and aims: Endoscopic transpapillary gallbladder stenting (ETGS) and endoscopic ultrasound-guided transmural stenting (EUGS) has been proposed as an alternative treatment in patients with acute cholecystitis (AC) who are not surgical candidate. We compared the outcomes of ETGS and EUGS in patients with AC at high surgical risk during an18-month follow-up.
Methods: We enrolled patients with AC at high surgical risk (Charlson Comorbidity Index ≥6) between 2021-2022. Patients were randomized to group A (received ETGS) and group B (received EUGS). A 7-Fr, 15-cm double-pigtail plastic stent (DPS) was used for ETGS. A 15- or 16-mm lumen-apposing metal stent (LAMS) or a 10x60 mm fully covered self-expandable metal stent with a 7-Fr/5-cm DPS for metallic stent anchoring (FCSEMS-DPS) were used for EUGS.
Result: We randomized 42 patients into group A (n=22) and group B (n=20). Group A had lower technical success rate (TSR) but did not reach statistical significance when compared to group B [19/22 (86.4%) vs. 20/20 (100%); p=0.09] and had similar clinical success rate (CSR) [19/19 (100%) vs. 20/20 (100%); p=1.00] (Table). Three patients did not achieve ETGS due to an acute angle of the cystic duct(n=1) and cystic duct stone obstructing a guidewire advancing into the gallbladder(n=2). The management after ETGS failure included subsequent EUGS (n=2) and EUS-guided gallbladder aspiration (n=1). Procedure-related adverse events (PAE) rates did not differ between group A and B (13.6% vs. 20%; p=0.58). In group A, 2 patients had recurrence after 9 months (at day 285 and 436) due to stent occlusion and both received ETGS stent replacement. In group B, FCSEMS-DPS migration was seen in one patient on routine plain film at 2 weeks after EUGS and this patient developed early recurrence at day 71, eventually this patient had LAMS as a replacement. At 3, 6, 12, and 18 months, the rates of recurrent AC in those who still survived were not statistically different [groups A and B: 0% (0/20) vs. 5.6% (1/18); p=0.56, 0% (0/18) vs. 7.1% (1/14); p=0.35, 5.9% (1/17) vs. 8.3% (1/12); p=0.47 and 13.3% (2/15) vs. 9.1% (1/11); p=0.64, respectively]. Death unrelated to gallstone was noted in 4 and 7 patients in group A and B, respectively (range 8-563 days after procedure). Kaplan-Meier plots demonstrated that the rates of recurrence were comparable between the two groups (p=0.61) during follow-up (median 394 days; range 8-700 days) (Figure).
Conclusion: ETGS tended to have a lower TSR compared to EUGS with comparable CSR and PAEs in the patients with AC who are not surgical candidate. During an 18-month follow-up, recurrent AC tended to be higher in ETGS group due to stent occlusion that developed at 9 months or later. For EUGS, early tubular stent migration was the only cause for recurrence, LAMS should be more preferred to prevent stent migration.

<b>Table. Outcomes of ETGS and EUGS in patients with acute calculous cholecystitis at high surgical risk (n=42)</b>

Table. Outcomes of ETGS and EUGS in patients with acute calculous cholecystitis at high surgical risk (n=42)

<b>Figure.</b><b> Kaplan-Meier analysis demonstrated </b><b>r</b><b>ecurrence-free survival curve in patients with acute calculous cholecystitis at high surgical risk who received ETGS and EUGS and had clinical success (n=39) </b>

Figure. Kaplan-Meier analysis demonstrated recurrence-free survival curve in patients with acute calculous cholecystitis at high surgical risk who received ETGS and EUGS and had clinical success (n=39)

Background:
The applications of lumen apposing metal stents (LAMS) have considerably expanded since its introduction. One such application is in patients with altered surgical anatomy other than Roux-en-Y gastric bypass with biliary pathology where anatomical reconfiguration has precluded access using a pediatric colonoscope or double balloon enteroscope. In these cases, entero-enteric LAMS (E-E LAMS) between adjacent limbs of small bowel allows direct access to the afferent limb and bile duct for endoscopic therapy. There is minimal literature on this technique for biliary access, and the success of E-E LAMS is not known. We aim to describe the safety and efficacy of E-E LAMS.

Methods:
This was a multicenter retrospective cohort study of patients who underwent E-E LAMS for the purpose of biliary intervention at 3 US centers. The primary outcome measured was technical success. Secondary outcomes measured included clinical success, defined as ability to provide efficient biliary intervention. Indications for E-E LAMS and adverse events associated with this procedure were also captured. Descriptive statistics were used to analyze the data.

Results:
17 patients underwent E-E LAMS for biliary access most often performed for biliary obstruction (47.1%) and cholangitis (45.5%) (Table 1). In 76.5% of patients, E-E LAMS was performed following failed access with deep enteroscopy or hepaticogastrostomy; for others E-E LAMS was the initial procedure. Technical and clinical success were achieved in 100% of patients. Roux-en-Y hepaticojejunostomy (RYHJ) anatomy was present in 64.7% of patients. 47.0% had malignant disease and 25% of those patients had evidence of omental metastases or ascites.

A 20 mm LAMS was used in 70.6% of patients. Access to the afferent jejunal limb was achieved either from the duodenum (47.1%) or the jejunum (52.9%). A wire-guided technique was used in 42.6%. In just over half of patients the LAMS was sutured after deployment and dilation. A single channel therapeutic scope was most frequently used to perform ERCP (76.5%). Two adverse events were noted; 1 patient had a perforation of the opposite jejunal wall that was treated with through-the-scope clips accessed through the LAMS, and one patient had minor bleeding that was managed conservatively. There was no misdeployment, stent dislodgement or migration.

Conclusions:
This is the largest study to date evaluating the safety and efficacy of E-E LAMS and demonstrates 100% technical and clinical success for biliary intervention with minimal risk of adverse events. These findings further broaden the spectrum of endoscopic options for biliary access in patients with altered anatomy and allow more advantageous endoscopes to be used for biliary interventions.

INTRODUCTION:
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing stent (LAMS) is conventionally performed on non-surgical candidates with acute calculous cholecystitis, with LAMS left in situ indefinitely. This may lead to their ingrowth, overgrowth, migration, bleeding, and other complications. LAMS is not designed as a permanently indwelling stent. Long-term effects of permanently indwelling LAMS in EUS-GBD still need to be evaluated. Susceptibility of gallbladder mucosa may present a potential risk to develop secondary pathology. A proactive approach with direct peroral cholecystoscopy (DPOCS) and complete stone clearance can allow the removal of LAMS and avoid the need for indefinite EUS-GBD.
METHODS:
In 2016, we have introduced a protocol for EUS-GBD patients who are not candidates for surgery and whose life expectancy is longer than 12 months. DPOCS is performed 6 weeks after EUS-GBD, combined either with contrast or CO₂cholecystogram and cholangiogram, in order to confirm the stone clearance. If needed, electrohydraulic lithotripsy (EHL) is engaged in to achieve complete stone clearance and to allow LAMS removal. Fistula after EUS-GBD is left to close spontaneously. All consecutive cases undergoing DPCOS were analyzed retrospectively.
Stent patency, spontaneous stone clearance, need for lithotripsy, a number of sessions, adverse events, cystic duct patency, recurrence of acute cholecystitis, and subsequent need for reintervention are evaluated as well.
RESULTS:
175 consecutive cases of DPOCS following EUS-GBD with LAMS were included, with median follow-up of 777 days (IQR 507.5) [191-1826].
DPOCS in 6 weeks after EUS-GBD confirmed complete stone clearance in 76.6% of cases. In 23.4% of cases, additional lithotripsy by means of electrohydraulic lithotripsy (EHL) was performed in order to achieve complete stone clearance and to allow LAMS removal (Figure 1). In 13.7% of EHL cases, more than one session was required (Figure 2). Mean number of DPOCS sessions was 1.16±0.43. With mean number of EHL sessions 1.68±0.65. In 16.6% of all cases, was impossible to confirm cystic duct patency. All procedures were performed on an outpatient/one-day basis. No adverse events related to follow-up DPOCS were observed. The recurrence of acute cholecystitis was observed in 5 (2.9%) of cases after the removal of LAMS. In 3 cases new EUS-GBD was performed and in 2 cases laparoscopic cholecystectomy. No stents were left behind in all 175 cases following complete stone clearance confirmation.
CONCLUSIONS:
A proactive approach in EUS-GBD seems to be a safe approach in the prevention of late adverse events and secondary pathologies of the gallbladder while avoiding permanently indwelling LAMS. DPOCS is a safe and reliable tool to achieve this goal. The recurrence rate of acute cholecystitis is similar to those with permanently indwelling LAMS.

FIGURE 1 - Complete spontaneous stone clearance vs need for proactive approach

FIGURE 1 - Complete spontaneous stone clearance vs need for proactive approach

FIGURE 2 - Number of DPOCS sessions required

FIGURE 2 - Number of DPOCS sessions required

Background:
It is unclear whether preoperative biliary drainage (PBD) by endoscopic retrograde cholangiopancreatography (ERCP) is equivalent to electrocautery-enhanced lumen-apposing metal stent (ECE-LAMS) before pancreatoduodenectomy (PD).
Methods:
Patients who underwent PBD for distal malignant biliary obstruction (DMBO) followed by PD were retrospectively included in nine expert centres between 2015 and 2022. The patients who went straight to surgery without PBD excluded from the study. ERCP or endoscopic ultrasound-guided choledochoduodenostomy with ECE-LAMS were performed. In intent-to-treat (ITT) analysis, patients drained with ECE-LAMS were considered the study group (first-LAMS group) and those drained with conventional transpapillary stent the control group (first-cannulation group). The rates of technical success, clinical success, drainage-related complications, surgical complications and oncological outcomes were analysed.
Results:
Population: Between 2015 and 2022, 156 patients from nine centres with resectable or borderline DMBO were included: 128 underwent ERCP (first-cannulation group) and 28 ECE-LAMS (first-LAMS groups) in first intent. Finally, 112 received transpapillary stents (all-stent group) and 44 patients received EUS-CD in the all-LAMS group (including 16 failure of ERCP stent placement).
The technical and clinical success rates were 83.5% and 70.2% in the first-cannulation group versus 100% and 89.3% in the first-LAMS group (p = 0.02 and p = 0.05 respectively). Technical and clinical success rates were similar whether patients were drained using ECE-LAMS in a high- or low-volume centres (<20 procedures) (p>0.05).
The overall endoscopic complication rate was 30.5% in first-cannulation group versus 17,9% in first-LAMS group (p=0,25). It was 31.2% in the patients with LAMS after ERCP failure (n = 16). No difference in endoscopic complication rates was found between high and low volume centres(18.2% vs 16.6%, p = 1). The median delay between biliary drainage and surgery or the start of chemotherapy was shorter in the first-LAMS group.
The overall complication rate after PD was higher in the first-cannulation group than in the first-LAMS group (92.2% vs. 75.0%, p = 0.016). In the PP analysis, it was lower in the all-LAMS group (77.3%) than in the all-stent group (93.7%, p = 0.008).
The overall complication rate over the entire patient journey was 93.7% in first-cannulation group vs. 92.0% in first-LAMS group (p = 0.04).
Oncological outcomes: Overall survival and progression-free survival did not differ between the groups.
Conclusion: PBD with ECE-LAMS is easier to deploy and more efficient than ERCP in patients with DMBO. It is associated with less surgical complications after pancreatoduodenectomy without compromising the oncological outcome. A future prospective randomised controlled trial is needed to confirm these results.

Background
Endoscopic retrograde cholangiopancreatography (ERCP) in patients with malignant distal biliary obstruction (MBO) is associated with a 75-94% technical success rate and up to 3-18% pancreatitis rate. Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) potentially results in higher technical success without the risk of pancreatitis. However, currently available prospective studies regarding EUS-CDS instead of ERCP used self-expandable metal stents (SEMS), while single step lumen-apposing metal stents (LAMS) may simplify the procedure and improve outcome. Therefore, this prospective pilot study assessed the effectiveness and safety of EUS-CDS using LAMS as primary drainage strategy in MBO.

Methods
Prospective single center pilot study in patients with a proven MBO and bile duct diameter of at least 12mm, requiring biliary drainage, excluding patients with gastric outlet obstruction. Patients underwent EUS-CDS using a 6x8mm LAMS. Primary outcome was technical success confirmed by a cholangiogram. Secondary outcomes were clinical success, defined as 50% decrease of bilirubin or relieve of symptoms after technical success, procedure time, adverse events (AEs) and re-interventions within 6 months.

Results
Overall, 22 patients were enrolled, see table. Technical success was achieved in 20/22 patients (91%). In one patient the stent was unintentionally placed in the cystic duct requiring a successful second EUS-CDS procedure. In the second patient the stent was maldeployed in the bile duct wall and ERCP was performed in the same procedure. Median procedure time was 12.5 minutes (IQR 7-16). Periprocedural AEs occurred in three patients (14%); limited bile leakage for which a short course of antibiotics was prescribed (n=2) and a self-limiting bleeding that led to blood cloths obstructing the stent for which a double pigtail stent (DPS) was placed (n=1).

Clinical success was achieved in 18/20 patients (90%). In the two remaining patients adequate biliary drainage was later achieved after additional DPS placement.

Ten patients (50%) experienced cholangitis after a median of 9 days (IQR 4.5-89.75). In two patients antibiotics sufficed, in eight patients a DPS was placed through the LAMS. Three of these patients needed additional re-interventions afterwards. Other AEs were; duodenal perforation during re-intervention successfully treated with an over the scope clip (n=1) and mild intermittent abdominal pain which resolved after DPS placement (n=1). One patient deceased within 30 days due to fulminant disease progression.

Conclusion
This study found a 91% technical success of EUS-CDS using LAMS as the primary drainage strategy in MBO and a low rate of procedure-related AEs. However, the substantial rate of stent dysfunction currently precludes EUS-CDS using LAMS solely as a valid alternative for ERCP.

Table. Baseline characteristics in 22 patients undergoing EUS-CDS

Table. Baseline characteristics in 22 patients undergoing EUS-CDS

Paul Fockens

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