Introduction

Lumen-apposing metal stents (LAMS) provide a conduit to access lumens close to the gastrointestinal tract to perform various interventions. While outcomes of LAMS placement in native anatomy have been reported, data on LAMS placement in surgically altered anatomy (SAA) is sparse.

Aims & Methods

We aim to assess technical, clinical, and safety outcomes of LAMS placement in patients with SAA for different indications. This was an international multicenter retrospective observational study at 25 tertiary-care centers through November 2023. Consecutive patients with SAA who underwent LAMS placement under endoscopic ultrasound guidance were included. Primary outcome was technical success defined as correct placement of LAMS. Secondary outcomes were clinical success and safety.

Results

255 patients with SAA (118 males; average age 61 ± 15 years) underwent LAMS placement. Surgical anatomy included total gastrectomy (n=3; 1.2%) subtotal gastrectomy (n=8; 3.1%), billroth I (n=19; 7.5%) billroth II (n=23; 9.0%), sleeve gastrectomy (n=16; 6.3%), pancreaticoduodenectomy (n=72; 28.2%), total pancreatectomy (n=3; 1.2%), roux-en-y gastric bypass (n=106; 41.6%), partial gastrectomy with roux-en-y (n=3; 1.2%); esophagectomy with partial gastrectomy (n=2; 0.8%). Indications were malignant biliary obstruction (n=32; 12.5%), cholecystitis (n=12; 4.7%), drainage of peri-pancreatic fluid collections (n=46; 18.0%); EUS- guided creation of enteric anastomoses (n=74; 29.0%); endoscopic ultrasound-directed transgastric ERCP (EDGE) (n=82; 32.2%); others (n=9; 3.5%). Both technical and clinical success ranged between 50% to 100%. Overall adverse event rate was 10.6% (n=27/255).

Conclusion

This study shows that placement of LAMS is associated with varying technical and clinical success rates in patients with SAA. The rate of adverse events is noteworthy, and thus, these procedures should be performed by expert endoscopists at tertiary centers.

Introduction

The introduction of lumen-apposing metal stents (LAMSs) has revolutionized the field of therapeutic endoscopic ultrasound (EUS). In the last decade, its utilization for off-label indications has markedly increased, particularly among patients with surgically altered anatomy to establish access in the excluded segment of the gastrointestinal tract. Indications for anastomosis creation include EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE), EUS-directed transgastric intervention (EDGI), or endoscopic reversal of Roux-en-Y gastric bypass (RYGB) for specific indications (see below).

Aims & Methods

This study aims to evaluate the effectiveness and safety of LAMS in patients with surgically altered anatomy for EDGE, EDGI, and reversal of RYGB. We collected data on all LAMS procedures conducted in patients with surgically altered anatomy, between October 2019 and February 2024 at the University Hospital of Ghent.
We used our prospective LAMS database and retrieved missing data from retrospective analysis of the medical patient records. The main outcome data of interest were technical success, clinical success, and adverse events. Technical success was defined as a successful placement of LAMS in the desired position. Clinical success was defined as either successful endoscopic access to the intended excluded gastrointestinal segment or achievement of the intended therapeutic goal when RYGB reversal was necessary. Adverse events were classified according to the AGREE criteria.

Results

A total of 73 LAMS procedures were performed: 70 cases of EUS-guided gastro-gastrostomy in patients with RYGB and 3 cases of EUS-guided gastro-enterostomy in patients with hepaticojejunostomy. Indications for LAMS procedures included 55 (75.3%) cases of EDGE, 13 (17.8%) cases of EDGI (such as gastroduodenoscopy and EUS), and 5 (6.8%) cases of RYGB reversal. Reversal of RYGB was required for one cachectic patient due to metastatic cholangiocarcinoma, three patients with hyperinsulinemic hypoglycemia, and one patient with therapy-resistant small intestinal bacterial overgrowth (SIBO).
The overall technical and clinical success rates were very high at 97.3% and 95.9%, respectively. Adverse events were observed in 11 out of 73 (15.1%) cases, including 7 (9.6%) minor events (AGREE score < 3) and 4 (5.5%) major events (AGREE score ≥ 3). Major events included stent migration (N=1), persistent fistula (N=2), and respiratory desaturation (N=1). All events could be successfully managed, and there were no procedure-related deaths. In 69.9% of cases, our method involved a dual-step approach, strategically implemented to await fistula maturation and reduce the risk of perforation. The median LAMS dwell time was 38 days (range 7, 431). LAMS was removed in 72.6% of the cases. Loss of LAMS patency occurred in 1 out of 73 (1.4%) cases and was endoscopically managed.

Conclusion

In conclusion, our study demonstrates that EUS-GG and EUS-GE offer an effective and safe approach to create anastomoses between gastrointestinal (GI) segments when performed by experts. With high technical (97.3%) and clinical (95.9%) success rates, LAMS proves beneficial for accessing excluded GI segments and reversing RYGB. Adverse events (15.1%) were mostly minor and manageable, with no procedure-related mortality. The extended patency duration and low re-intervention rate highlight LAMS as a minimally invasive and durable option in therapeutic endoscopic ultrasound procedures. Further prospective studies are required.

Introduction

EUS-guided choledochoduodenostomy (EUS-CDS) is a minimally invasive procedure used to treat malignant biliary obstruction (MBO) by the transduodenal placement of a lumen-apposing metal stent (LAMS) into the extrahepatic bile duct. In order to identify the factors that contribute to safe and effective EUS-CDS procedures using LAMS we performed a systematic review of the literature with meta-analysis.

Aims & Methods

The methodology of our analysis was based on PRISMA recommendations. Electronic databases (Medline, Scopus, EMBASE) were searched up to November 2022. Full articles including patients with distal malignant biliary obstruction who underwent EUS-CDS using LAMS after failed ERCP were eligible. Technical success, clinical success, and adverse events were pooled by means of a random model. Multivariate meta-regression and subgroup analysis were performed to assess the correlation between outcomes and different variables.

Results

Twelve studies with 845 patients were included in the meta-analysis. Pooled technical and clinical success rates were 96% (95%CI: 94%-98%; I2=52.29%) and 96% (95%CI: 95%-98%), respectively, with no significant association with baseline characteristics, such are sex, age, common bile duct (CBD) diameter and stent size. The pooled AE rate was 12% (95%CI: 8%-16%; I2=71.62%). The AE rate was significantly lower when using an 8x8mm stent as compared to a 6x8 mm LAMS (OR 0.59, 0.35-0.99; p=0.04), with no evidence of heterogeneity (I2=0%).

Conclusion

EUS-CDS with LAMS is confirmed to be a safe and effective option for relief of MBO. The selection of appropriate stent size is crucial for achieving optimal outcomes.

Introduction

The use of lumen-apposing metal stents (LAMS) in therapeutic endoscopy has significantly increased in recent years due to their expanding role in a variety of procedures, such as drainage of pancreatic fluid collections, endoscopic ultrasound (EUS)-guided choledochoduodenostomy, EUS-guided gallbladder drainage, gastro-enteric anastomoses, or abscess drainage.

Aims & Methods

This study aims to analyze the spectrum of indications and complication rates between 2016 and 2024. It includes a retrospective analysis of all patients who received LAMS at our center during this period.

Results

A total of 201 LAMS placements were performed: 82 for biliary drainage, 69 for peripancreatic collections, 41 for gastric outlet obstruction, 8 for abscesses, and 1 for endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE). Initially, LAMS were primarily used for the drainage of collections; however, in recent years, anastomoses have become the predominant indication. Overall, we performed 124 anastomoses (61.7%) over the observation period. Among the patients, 86 (42.8%) had malignancies necessitating LAMS placement.
The overall complication rate was 7.5% (15 cases): 6 cases of primary stent maldeployment, 5 bleeds, 2 infections related to walled-off necrosis (WON)/LAMS obstruction, and 2 buried stents. Three patients required surgery, and one underwent radiological embolization for a leak from a splenic artery pseudoaneurysm. No 30-day mortality was observed, although one patient died 65 days post-drainage, 36 days after LAMS extraction, due to splenic artery bleeding.

Conclusion

LAMS use has evolved substantially at our institution, shifting from drainage to anastomotic applications, with EUS-guided gallbladder drainage now being the most common procedure.
Despite the broad spectrum of indications, the complication rate remained low (7.5%) and was managed non-surgically in 80% of cases.
These findings support continued expansion of LAMS in therapeutic endoscopy.

Introduction

Endoscopic stenting is considered the mainstay of biliary treatment for benign biliary strictures [1]; temporary insertion of multiple plastic stents or of a fully covered self-expandable metal stent (FC-SEMS) are the preferred methods due to their favorable results [2]. However, there is a not-negligible rate of stricture recurrence and spontaneous stent migration, the latter being a leading cause of treatment failure [3]. Lumen-apposing metal stents (LAMS), developed for transluminal drainages, have a unique design with short length, large diameter and wide flanges which make them less prone to migration [4]. LAMS have recently been proposed as a novel modality for treating short benign gastrointestinal strictures [5].

Aims & Methods

Aim of our study was to describe the intraluminal use of LAMS to treat short benign biliary strictures. This was a retrospective, single-arm, single Centre study. All consecutive patients who underwent retrograde LAMS placement for benign biliary strictures, from October 2016 to July 2022, were included. Clinical data, including stricture etiology, previous upper-GI or hepatobiliary surgery, previous treatments for biliary stricture and type of LAMS used were collected from medical records. Primary outcomes were technical success and stricture resolution; secondary outcomes were stricture recurrence, number of endoscopic retrograde cholangiopancreatography (ERCP), stent migration.

Results

During the study period, seventy patients (35 male, mean age 67, range 27-90 years) underwent retrograde LAMS placement for benign biliary strictures; distal biliary stricture was the most common etiology (n=36), followed by anastomotic stricture (n=31) and proximal non-anastomotic stricture (n=3). LAMS placement was a second-line therapy, after failure of other methods, in 38 patients (54.2%). A 16-mm LAMS was used in 44 patients and a 12-mm LAMS in 26 (NAGI stent, Taewoong Medical, South Korea). Technical and clinical success were obtained in 100% and 83% of patients, respectively. Stent migration occurred in 9 (12,8%) of cases, 3 of which determined treatment failure. Stricture recurred in 9 patients within a mean of 16 months onset (range 3-30 months). We found a statistically significant higher success if the treatment was performed as a second line therapy than as a first attempt, with success rate of 91.1% and 79.3%, respectively (p=0.04). No statistically significant differences were seen between 16-mm LAMS and 12-mm LAMS placement (87% vs 76%, p=0.23).

Conclusion

LAMS placement could be a safe and effective alternative for short, benign biliary strictures, especially as a second line therapy in patients who experienced a previous endoscopic treatment failure.

References

1. Nakai Y, et al. International consensus statements for endoscopic management of distal biliary stricture. J Gastroenterol Hepatol. 2020 Jun;35(6):967-979. doi: 10.1111/jgh.14955. PMID: 31802537.
2. Dumonceau JM, et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy. 2018 Sep;50(9):910-930. doi: 10.1055/a-0659-9864. PMID: 30086596.
3. Park JS, et al. Long-term outcomes of covered self-expandable metal stents for treating benign biliary strictures. Endoscopy. 2016 May;48(5):440-7. doi: 10.1055/s-0042-101406. PMID: 26919262.
4. Sharma P, et al. Alternative uses of lumen apposing metal stents. World J Gastroenterol. 2020 Jun 7;26(21):2715-2728. doi: 10.3748/wjg.v26.i21.2715. PMID: 32550749.
5. Larson B, Adler DG. Lumen-apposing metal stents for gastrointestinal luminal strictures: current use and future directions. Ann Gastroenterol. 2019 Mar-Apr;32(2):141-146. doi: 10.20524/aog.2018.0337. PMID: 30837786;

Introduction

Endoscopic biliary drainage (BD) in patients with altered anatomy is a challenging scenario reducing the chance of clinical success compared to standard anatomy. The choice between different BD approaches is still not standardized and relies on local availability and expertise.

Aims & Methods

Aim of this study was to explore the type and the number of endoscopic BD approach in patients with altered anatomy in different Italian centers. This was a retrospective multicenter cohort study within the i-EUS network of biliopancreatic endoscopy. All adult patients with upper GI surgical altered anatomy who underwent endoscopic BD for any indication in the last 5 years were enrolled. Patients with Billroth-I or sleeve gastrectomy were excluded. Patients with duodenopancreasectomy were grouped with patients with BillrothII reconstruction for the statistical analysis. Fisher’s exact test and Mann-Whitney test were used when appropriate.

Results

21 centers participated in the study. All centers were equipped for interventional endoscopic ultrasound (EUS) whereas only 7 centers had also the availability of device-assisted enteroscopy (DAE). 428 patients were enrolled. Clinical and BD techniques characteristics of patients are described in table 1. Indication to BD was not different between patients with Billroth-II (B-II, N=263) or Roux-en-Y (RY, N=165) reconstructions. 16% of patients had at least one previous failed BD attempt. B-II anatomies were more frequently managed transpapillary with a duodenoscope or a forward viewing scope (85%), whereas in case of RY reconstruction BD approach was more heterogeneous. In 68% of RY cases endoscopic BD was performed with a luminal approach (in 43% of cases with standard scopes). In patients who underwent to EUS-BD, hepaticogastrostomy or antegrade stenting were performed in 74% of cases mostly for malignant indications (90%). Type of surgical reconstruction did not affect the clinical success (84% in BII and 79% in RY, p=ns). Interventional EUS demonstrated a higher clinical success compared to DAE (94% vs 73%, p=0.004). The total number of procedures to achieve clinical success was similar between B-II and RY patients. Patients who failed endoscopic BD for whom follow-up was available were managed by PTBD or surgery in 71% and 15% of cases respectively.

Conclusion

Endoscopic BD in altered anatomy has a sub-optimal clinical success compared to standard anatomy. A relevant proportion of patients requires more than one endoscopic attempt to achieve the clinical success. Despite the recent advent, interventional EUS is optioned in a significant proportion of patients and demonstrated a high efficacy in patients with surgically altered anatomy.