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.
