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.

Background: Enteral stents (ES) and the more recent, Endoscopic ultrasound guided Gastrojejunostomy (EUS-GJ) are endoscopic techniques for palliation of malignant gastric outlet obstruction with benefit in terms of early resumption of oral intake and relatively non-invasive nature of procedure. Previous studies have shown EUS-GJ to be superior to ES in terms of clinical success in short and long term. We hypothesized that the benefit of EUS-GJ was driven by better gastric emptying as compared to ES. The aim of this pilot study was to analyze the difference in gastric emptying times between EUS-GJ and ES.
Methods: Consecutive patients who underwent ES and EUS-GJ for palliation of gastric outlet obstruction at a tertiary care oncology institute were screened over 6 months between April and October 2022. Patients should have either undergone ES with WallFlex Enteral Stents (Boston Scientific Ltd., USA; 22 mm diameter) or EUS-GJ using 20 X 10 mm Hot Axios stents (Boston Scientific Ltd., USA). Exclusion criteria were poor performance status (ECOG >2) or other critical illness for which patient was hospitalised. On follow-up at 2 weeks after ES or EUS-GJ, patients underwent Gastric Emptying Study after consumption of a semisolid test meal (porridge 100-150 gm) labelled with 0.8-1.2 mCi of Technetium-99m Sulphur colloid using a dual-head gamma camera. Patients were nil-per-orally prior to procedure. Readings of gastric emptying were taken at 0, 1, 2 and 4 hours and t1/2 of semisolid emptying was calculated. In addition, Gastric Outlet Obstruction symptom score (GOOSS) at baseline and at 2 weeks were also compared. Primary outcome measure was Gastric emptying time with t1/2 of semisolid test meal. Normal value of t1/2 was 120 mins for semisolids as per previous Indian normative data. Secondary outcome was clinical success as measured by 2-point increase in GOOSS at baseline and at 2 weeks.
Results: Twenty-Six patients were enrolled in this pilot study (12 EUS-GJ and 14 ES). There were no differences with respect to age, sex, site of obstruction, Charlson comorbidity index, baseline performance status or presence of ascites (Table 1). There was significant difference in the median Gastric Emptying t1/2 between those who underwent EUS-GJ and ES (86.5 mins vs 133 mins)(p=0.036) (Figure 1). Abnormal emptying was seen in 1 (8.3%) patient who underwent EUS-GJ and 6 (42.8%) patients undergoing ES (p=0.08). Clinical success at 2 weeks was achieved in 91.6% patients undergoing EUS-GJ and 71.4% patients undergoing ES (p=0.33).
Conclusion: There is a significantly delayed gastric emptying after ES as compared to EUS-GJ. Narrowing secondary to tumor itself may impact clearance of stomach contents. Rapid emptying of gastric contents may explain the higher clinical success rate achieved by EUS-GJ as compared to ES.

Introduction
Despite the advantages of EUS-guided Gastroenterostomy (EUS-GE) over enteral stenting (ES) for malignant Gastric Outlet Obstruction (mGOO) in retrospective series, ES is still advocated for patients with shorter life expectancy, whilst no prospective comparison is available.

Methods
All consecutive patients with mGOO treated between March-2021 and June-2022 in a tertiary, academic center were allocated to EUS-GE versus ES after multidisciplinary discussion and included in a prospective registry (PROTECT, NCT04813055) with monthly follow-up.
Technical/Clinical Success, Adverse Events, Symptom’s recurrence, and Survival were compared after 1:1 matching for primary disease, disease stage, ASA score and Charlson Comorbidity Index (CCI).

Results
During study period, 52 EUS-GE and 28 ES were performed (higher baseline ASA score [p=0.02] in the ES group).
After matching, 22 patients per arm were analysed, with no baseline differences in age, sex, BMI, primary disease (pancreatic cancer=86%) and stage (metastatic=69%), CCI (8 [5-9]) and ASA score.
Technical success was 100% in both arms (p=1). Patients treated with EUS-GE experienced higher clinical success (ability to eat at least a soft solid: 100% vs 73%, p=0.01) and shorter refeeding time (2[1-2] versus 3.5[2-7] days, p=0.002), with a trend to reduced adverse events (5% vs 14%, p=0.3). During a median FU of 75[42-103] and 45[18-143] days respectively, symptoms’ recurrence was 5% vs 29% (p=0.04) without any difference in overall survival.

Conclusions
In this first, prospective, matched comparison including frailer patients with more advanced neoplasms, EUS-GE confirmed higher and faster clinical success than ES, with reduced dysfunction and without any increased invasiveness.

Michele Reni

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