Society: ASGE

Background
EUS-guided gastroenterostomy (EUS-GE) is a novel method for palliating gastric outlet obstructon due to unresectable malignancies. The procedure is associated with high technical and success rates and potentially lower recurrent obstructions, reinterventions and better gastric outlet obstruction scores. However, results from randomized controlled studies are lacking. Hence, the aim of the current study is thus to compare EUS-GE with the use of a double balloon occluder (EPASS) and duodenal stent (DS) under a randomized setting. We hypothesize that EPASS could reduce the re-intervention rates when compared to DS.
Methods
The was a prospective multi-centered randomized controlled study conducted between December 2020 to February 2022 in 7 institutions. We included consecutive patients suffering from malignant gastric outlet obstruction due to unresectable primary gastro-duodenal or pancreatico-biliary malignancies. Included patients were randomized to receive EPASS or DS. The primary outcome measurement was the 6 month re-intervention rate. Secondary outcomes include technical and clinical success, adverse events rate, mortality, pre and post stenting gastric outlet obstruction scores (GOOS), causes of stent dysfunction, the duration of stent patency, cost and quality of life assessment scores.
Results
During the study period, 97 patients were included (EPASS 48, DS 49). There were no significant differences in background demographics. The EPASS group was associated with significantly better 6 month stent patency rate (97.9% vs 71.4%, P < 0.001) and mean stent patency days [176.7 (22.7) vs 152.9 (59.1), P = 0.013]. The reintervention rate was significantly lower in the EPASS group (2.1% vs 28.6%, P < 0.001). The 1 month gastric outlet obstruction score was significantly better in the EPASS group [2.3 (0.7) vs 1.9 (0.95), P = 0.031]. There were no significant differences in technical and clinical success rates (95.8% vs 100%, P = 0.242 and 100% vs 91.7%, P = 0.117 respectively), procedural time [40.3 (16.6) vs 37.8 (91.7), P = 0.865], hospital stay [7.1 (9.4) vs 9.0 (7.2), P = 0.289], 30-day mortality [5 (10.4) vs 1 (2), P = 0.097] and 30-day adverse events [7 (14.6) vs 7 (14.6), P = 1].
Conclusions
EPASS significantly improved the stent patency and eating functions in patients suffering from malignant gastric outlet obstruction. This should be the procedure of choice when the expertise is available.

Comparison of outcomes between the 2 groups.

Comparison of outcomes between the 2 groups.

The Kaplan-Meier curve showing the cumulative stent patency rate of the 2 groups of patients. The stent patency rate is significantly higher in the EPASS group at 6 months (P < 0.001).

The Kaplan-Meier curve showing the cumulative stent patency rate of the 2 groups of patients. The stent patency rate is significantly higher in the EPASS group at 6 months (P < 0.001).

Background and Aims:
Gastric outlet and biliary obstruction are common manifestations of gastrointestinal malignancies and some benign diseases, for which a standard treatment would be surgical gastroenterostomy and hepaticojejunostomy (i.e. ‘double bypass’). Therapeutic endoscopic ultrasound (EUS) has allowed for the creation of an EUS-guided double bypass using EUS-guided gastroenterostomy (EUS-GE) and biliary drainage (EUS-BD). However, same-session double EUS-bypass has only been described in small proof-of-concept series and lack comparison with surgical double bypass.

Methods:
A retrospective multicenter analysis was performed of all consecutive same-session double EUS-bypass procedures performed in 5 academic centres. EUS-GE was performed using either WEST or EPASS-technique, whereas EUS-guided hepaticogastrostomy, choledochobulbostomy, rendez-vous and antegrade stenting were allowed for EUS-BD. Surgical comparators were extracted from these centers’ databases from the same time interval. Efficacy, safety, hospital stay, nutrition and chemotherapy resumption, long-term patency and survival were compared.

Results:
In total, 154 patients were identified, of which 53 (34.4%) received treatment with EUS and 101 patients with surgery (65.6%). At baseline, patients undergoing EUS exhibited higher ASA scores and a higher median Charlson Comorbidity Index (9.0 [IQR 7.0-10.0] vs. 7.0 [IQR 5.0-9.0], p<0.001).
Technical success (96.2% vs. 100%, p=0.117) and clinical success rates (90.6% vs. 82.2%, p=0.234) were similar when comparing EUS and surgery. Overall (11.3% vs. 34.7%, p=0.002) and severe adverse events (3.8% vs. 19.8%, p=0.007) occurred more frequently in the surgical group. In the EUS group, median time to oral intake (0 [IQR 0-1] vs. 6 [IQR 3-7] day(s), p<0.001) and hospital stay (4.0 [IQR 3-9] vs 13 [IQR 9-22] days, p<0.001) were significantly shorter.

Conclusion:
Despite being used in a patient population with more comorbid conditions and potentially more advanced disease stage, same-session double EUS bypass achieved similar efficacy with lower overall and severe adverse events when compared to surgery. The current study furthermore suggests that EUS-GE and EUS-BD can be performed safely and effectively in a single session. Although future efforts should be directed towards further optimizing outcomes of double EUS-bypass, and adequate long-term biliary drainage in particular, the current study underlines the usefulness of EUS in patients with both GOO and biliary obstruction.

Halit Topal

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