Endoscopic ultrasonography-guided gastroenterostomy for malignant and benign gastric outlet obstruction: a systematic review and meta-analysis

Raffaele Mantaa, Angelo Zullob, Vincenzo De Francescoc, Marco Spadaccinid,e, Cesare Hassand,e, Luigi Gattaf

ASL Toscana Nord-Ovest, Spedali Riuniti Hospital, Livorno; Nuovo Regina Margherita Hospital, Rome; Riuniti Hospital, University of Foggia; Humanitas University, Pieve Emanuele; Humanitas Clinical Research Center, Rozzano, UOC Screening Aziendali, Azienda USL Toscana Nord-Overst, Livorno, Italy

aDigestive Endoscopy Unit, ASL Toscana Nord-Ovest, Spedali Riuniti Hospital, Livorno, Italy (Raffaele Manta); bGastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy (Angelo Zullo); cGastroenterology and Endoscopy Unit, Department of Medical and Surgical Sciences, Riuniti Hospital, University of Foggia, Foggia, Italy (Vincenzo De Francesco); dHumanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy (Marco Spadaccini, Cesare Hassan); eHumanitas Clinical and Research Center, IRCCS, Endoscopy Unit, Rozzano, Italy (Marco Spadaccini, Cesare Hassan); fUOC Screening Aziendali, Azienda USL Toscana Nord-Ovest (ATNO), Livorno, Italy (Luigi Gatta)

Correspondence to: Raffaele Manta, MD, Digestive Endoscopy Unit, ‘Spedali Riuniti’ Hospital, Livorno, Italy, e-mail raffaelemanta4@gmail.com
Received 22 May 2025; accepted 14 July 2025; published online 14 August 2025
DOI: https://doi.org/10.20524/aog.2025.0989
© 2025 Hellenic Society of Gastroenterology

Abstract

Background Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) with a lumen-apposing metal stent has been proposed as a treatment for patients with gastric outlet obstruction (GOO). We performed a systematic review and meta-analysis to compute the technical success, clinical success and complication rates of EUS-GE in treating GOO due to either neoplastic or benign diseases.

Methods The literature search was conducted in PubMed, EMBASE and the Cochrane Central Register of Controlled Trials, from inception until January 23, 2025, according to the PRISMA and MOOSE statement guidelines. The primary objective was to assess both technical and clinical success. A secondary outcome was to rate the adverse events.

Results Data from 39 studies involving 2845 patients were analyzed. The pooled technical success rate was 95.1%, and the procedure was successful in 95.3% and 95.1% of patients with malignant or benign diseases, respectively. Clinical success was achieved in 93.5% of all patients where the procedure had technical success, and in 93.1% and 94.4% of those treated for malignant and benign conditions, respectively. The overall rate of adverse events was 18.5%, including perforation (4.4%), bleeding (2.7%), stent migration (1.4%), stent closure (3.3%), infection (4.4%), and fistula (2.3%). The procedure-related mortality was 1.4%.

Conclusion EUS-GE appears to be a viable approach for the treatment of GOO patients, for both malignant and benign diseases, with favorable outcomes and an acceptable safety profile.

Keywords Endoscopic ultrasonography, gastroenterostomy, gastric outlet obstruction, lumen-apposing metal stent

Ann Gastroenterol 2025; 38 (5): 545-553

Introduction

Gastric outlet obstruction (GOO), due to either malignant or benign conditions, is traditionally treated with surgery, which improves the quality of life and survival of patients with the condition [1]. A less invasive approach, with endoscopic stenting of strictures, was subsequently introduced, but the technical unfeasibility in some cases and stent migration are potential limitations [2]. In the last decade, endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) was pioneered as a novel endoscopic method to palliate neoplastic GOO and, more recently, to treat benign obstructions, mainly due to gastroduodenal or pancreatic diseases [3-6]. Basically, EUS-GE involves creating a gastrointestinal anastomosis between the stomach and an intestinal loop, through electrocautery-enhanced dilators and lumen-apposing metal stents (LAMS), bypassing the intestinal obstruction [7]. It is performed via different procedures, namely the direct EUS-GE technique, which involves puncturing a small bowel loop adjacent to the stomach, or by preventively identifying the intestinal loop using either a nasobiliary catheter or a double-balloon device. A head-to-head comparison showed similar performance between the direct and assisted techniques [8].

Some studies reported the feasibility of EUS-GE for the treatment of GOO, and a few systematic reviews pooled the data coming from the early experiences, comparing EUS-GE with enteral stenting and surgery, and underlining its favorable profile in term of technical and clinical success [9-11]. In addition, EUS-GE was found to cause fewer adverse events (AEs) than surgery [12]. The current European Society of Gastrointestinal Endoscopy guidelines suggest considering EUS-GE in patients with malignant GOO who are poor surgical candidates, but the quality of evidence was low because of the lack of aggregate data [3]. Furthermore, evidence relating to EUS-GE in benign conditions is still limited to small case series. We therefore performed a systematic review and meta-analysis to investigate the efficacy and safety profile of EUS-GE in treating patients with GOO due to either neoplastic or benign diseases.

Materials and methods

Search strategy and study selection

This meta-analysis was developed according to the PRISMA and to the MOOSE statement guidelines [13,14]. A search of the medical literature was conducted using PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials, from inception to January 23, 2025. Studies were identified using the following terms as free text and, where possible, as MeSH and/or Emtree Term: malignant or benign gastric outlet obstruction, gastrectomy, gastric bypass, gastroenterostomy, gastrojejunostomy, gastro-entero-anastomosis, endoscopic ultrasound guided gastroenterostomy, balloon-assisted gastroenterostomy, BAGE, Hot Axios, Niti-S SPAXUS, electrocautery lumen-apposing metal stents, pure natural orifice transluminal endoscopic, hanarostent, lumen-apposing metal stents. Only full papers published in English were considered. Inclusion criteria were: a) patients aged ≥18 years; b) EUS-GE performed for treatment of GOO due to either benign or malignant diseases; c) availability of (or clearly extrapolatable) data on both technical and clinical success; d) studies including ≥10 patients; and e) data on procedure-related AEs during the procedure and/or at follow up. When more than 1 publication from the same investigator group was available, only the most updated version, including the entire sample size, was considered for this meta-analysis. The above search strategy identified relevant studies, and bibliographies of all identified relevant studies were used to perform a recursive search. Abstracts of the papers identified by the initial search were evaluated for appropriateness, in a blinded manner, independently by 2 authors (AZ and VDF), who independently extracted the following data: 1) total number of patients treated with EUS-GE; 2) number of patients treated for either malignant or benign diseases; 3) technical success rate; 4) clinical success rate; and 5) AEs, namely perforation, bleeding, stent migration, stent closure, infection, fistulas, and death. Any disagreement was resolved by discussion between the 2 authors. Risk of bias for randomized controlled trials (RCTs) was assessed as described by the Cochrane handbook [15]. The Newcastle-Ottawa scale (possible highest score: 9) was used to assess the quality of cohort studies [16]. Single-arm cohort studies (i.e., case series) [17] were evaluated using the 20-item quality appraisal checklist developed by the Institute of Health Economics (Canada) [17,18].

Outcomes

The primary objective was to assess both technical and clinical success. Technical success was defined as the successful placement of a stent across the site of obstruction, confirmed by endoscopy or fluoroscopy [7]. Clinical success was evaluated according to per-protocol analysis—i.e., in patients where the procedure achieved technical success—and was defined as at least a 1-point increase in the gastric outlet obstruction score system, which includes 4 stages (0: no oral intake; 1: liquid diet; 2: semi-solids/low-residue diet; and 3: unmodified diet) at follow up [2]. AEs were computed as secondary outcomes.

Statistical analysis

Data for primary and secondary outcomes were pooled from all kinds of studies, using a random-effects model to yield a more conservative estimate [19]. Heterogeneity between trials was assessed using the chi-squared test for heterogeneity, and the I2 statistic was also calculated [20]. StatsDirect (StatsDirect, Ltd. England) was used to generate forest plots for primary and secondary outcomes, with 95% confidence intervals (CIs), as well as funnel plots. If the number of studies was ≥10, funnel plots were also assessed for evidence of asymmetry and possible publication bias or other small study effects, using Egger’s linear regression [15, 21].

Results

Descriptive analysis

As shown in Fig. 1, the search identified 4384 citations. After duplicates had been removed, and records where the title and/or abstract were not pertinent excluded, 2600 reports were assessed for eligibility. At the end of the process, 39 studies, including 2485 patients (male 1341, 54%), were evaluated in the systematic review and meta-analysis (Table 1) [22-60]. The median number of enrolled patients was 44, ranging from 11 to 267 among studies. There was 1 RCT [56], 9 cohort studies [24,39-42,47,49,53,55], and 29 case series [22,23,25-38,43-46,48,50-52,54,57-60]. Risk of bias was low for the RCT [56] (Supplementary Table 1), the quality of the cohort studies was good (Supplementary Table 2), and the value of case series studies ranged from 15-17 (Supplementary Table 3).

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Figure 1 Flow chart showing the literature review

Table 1 Characteristics of included studies*

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Technical success

As shown in Fig. 2, the pooled technical success rate was 95.1% (94.0-96.1), when all the 2485 treated patients in the 39 studies were considered [22-60], with evidence of publication bias (Egger’s test: P=0.0014; Supplementary Fig. 1), and a moderate value of I2: 29.3%. In patients with malignant disease (N=1458; 21 studies; Supplementary Fig. 2), the procedure was successful in 95.3% of cases (95%CI 94.2-96.4) [24,26,28,29,31,33,34,37-41,46,47,49,50,54-56,59,60], with no evidence of heterogeneity or publication bias (Supplementary Fig. 3). Similar results were found in patients with a benign disease (N=230; 9 studies; Supplementary Fig. 4) [25,28,29,31,46,48,50,57,59], with a pooled technical success rate of 95.1% (95%CI 92.0-97.5). As the number of studies was <10, no funnel plot or Egger’s test was performed. Complete information on heterogeneity and publication bias is provided in Supplementary Table 4.

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Figure 2 Forest plot of the technical success rate of all patients (with malignant or benign disease)

Clinical success

As shown in Fig. 3 (N=2398; 39 studies) [22-60], the overall clinical success rate was 93.5% (95%CI 91.5-95.3) in patients with available data following a successful procedure, with substantial heterogeneity I2: 66.9% and no publication bias (Supplementary Fig. 5). In patients with malignant diseases (N=1371; 21 studies) [24,26,28,29,31,33,34,37-41,46,47,49,50,54-56,59,60], the clinical success was 93.1% (95%CI 91.0-95.0), with moderate heterogeneity I2: 45% and publication bias (P=0.0162; Supplementary Fig. 6,7). In patients with benign conditions (N=230; 9 studies) [25,28,29,31,46,48,50,57,59], clinical success was 94.4% (95%CI 86.1-99.1; Supplementary Fig. 8) with substantial heterogeneity (I2=72.8%). As the number of studies was <10, no funnel plot or Egger’s test was performed. Complete information on heterogeneity and publication bias is provided in Supplementary Table 4.

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Figure 3 Forest plot of the clinical success rate of all patients (with malignant or benign disease)

AEs

Based on the available data, the rate of AEs was 18.5%, including intestinal perforation in 4.4% (95%CI 2.8-6.0) of 2437 patients (38 studies; I2=64.9% and no publication bias; Supplementary Fig. 9,10) [22-55,57-60]; intestinal bleeding in 2.7% (95%CI 1.8-3.7) of 2437 cases (38 studies; I2=39.5% and publication bias: P<0.0001; Supplementary Fig. 11,12) [22-55,57-60]; stent migration in 1.4% (95%CI 0.9-1.2) of 2397 patients (37 studies; I2=13.7% and publication bias: P=0.0077; Supplementary Fig. 13,14) [22-36,38-59]; stent closure in 3.3% (95%CI 2.3-4.5) of 2158 cases (35 studies; I2=43.3% and publication bias: P<0.0001; Supplementary Fig. 15,16) [22-34,36,38,39,41-59]; infection in 4.4% (95%CI 2.5-6.7) of 2041 patients (32 studies; I2=79.2% and publication bias: P=0.0015; Supplementary Fig. 17,18) [22,24-27,29-34,37-39,41-47,49-59]; and fistulas in 2.3% (95%CI 1.3-3.7) of 590 cases (9 studies; I2=0% and publication bias: P<0.0011; Supplementary Fig. 19) [28,33,36,38,44,46,57-59]. As the number of studies was <10, no funnel plot or Egger’s test was performed. A procedure-related death occurred in 1.4% (95%CI 0.7-2.2) of 1671 patients (30 studies; I2=16.4% and no publication bias; Supplementary Fig. 20,21) [22-29,31-34,36,39,41,43-45,47-53,55-59]. Complete information on heterogeneity and publication bias is provided in Supplementary Table 4.” in Complete information on heterogeneity and publication bias is provided in Supplementary Table 4. The PRISMA 2020 and MOOSE checklists are reported in Supplementary Tables 5 and 6, respectively.

Discussion

Gastric and pancreatic cancers are the 5th and 6th largest contributors to cancer-related mortality worldwide, and both types of neoplasia may cause GOO syndrome in more advanced stages [61]. Moreover, some benign causes, such as peptic, non-steroidal anti-inflammatory drugs, radiation, anastomotic strictures, groove pancreatitis, polyps and stones may provoke GOO [62]. GOO syndrome entails persistent vomiting, dehydration, severe weight loss and cachexia, so that patients suffer a poor quality of life and are at increased risk of mortality, beyond the underlying diseases [62]. Surgical treatment aiming to bypass the intestinal obstruction is habitually performed as a palliative solution [63,64]. The introduction of the EUS-GE procedure has increased the possibilities of endoscopic treatment in these patients, as a less invasive approach when compared to surgery [12]. While EUS-GE could be pivotal in allowing clinical improvement towards recovery in patients with benign diseases, the indication for this procedure in oncological patients, often with poor life expectancy, should be opportunely discussed by multidisciplinary teams, since the approach has no curative intent [65]. Currently, EUS-GE should be considered in GOO patients who are poor surgical candidates, but current guidelines could be improved by more evidence [7].

How feasible, successful and safe is the EUS-GE in resolving GOO? To answer this relevant question, we performed the present systematic review and meta-analysis. Taking into account the available data from almost 2500 patients, we found that EUS-GE is feasible in 95% of cases, irrespective of the underlining disease causing the GOO. Moreover, when the procedure is successful, a clinical improvement of obstructive symptoms, allowing at least the introduction of a liquid diet, occurs in 93.5% of all patients, with no difference between benign and malignant conditions. Overall, these findings suggest that GOO can be successfully treated via the EUS-GE approach in the large majority of patients. However, since the data on benign diseases involved less than 250 patients, more information is needed. Besides being less invasive, EUS-GE is certainly cheaper as compared to surgical treatment, incurring both lower direct costs and a shorter hospital stay [9-11]. Although it is expected to be more costly than standard endoscopic stenting, the need for repeated procedures due to stent closure or migration was reported to be significantly higher following endoscopic stenting than with EUS-GE, and this may impact the overall costs [66]. Moreover, data from a recent systematic review demonstrated a significantly shorter hospital stay in favor of the EUS-GE group (mean difference: -2.82, 95%CI -5.05 to -0.59; P=0.01; I2=94%) as compared to duodenal stenting [10].

On the other hand, the type of EUS-GE procedure performed does not seem to be a matter for concern. Indeed, data from a multicenter study showed similar rates for both technical and clinical outcomes between the balloon-assisted and direct techniques—the latter being the preferred method, given its shorter procedure time when compared with the balloon-assisted approach [23].

Unfortunately, the EUS-GE procedure is not without risks. Data we analyzed found that an AE developed in up to 18.5% of patients, including intestinal perforation and bleeding, which occurred in 7% of procedures. However, in at least some cases, perforation and bleeding were successfully managed with clipping during endoscopy, even in the same session, so that the procedure was accomplished with a second LAMS without resorting to a surgical approach. Following a successful procedure, 7% of patients developed stent closure, stent migration or fistula at follow up. Therefore, the endoscopist should keep in mind that, in contrast to the EUS-guided biliary LAMS, a fistula may develop following EUS-GE, mainly involving the colon (gastro-colic; gastro-jejuno-colonic; gastro-colonic-jejunal), which may be temporarily interposed or adjacent to the jejunal loop during the procedure. Overall, the procedure-related mortality rate was 1.4%, which appears to be acceptable, particularly when considering the general frailty of the treated patients, and lower than that reported with the surgical approach [11].

Undeniably, a limitation is that EUS-GE is a technically challenging procedure, requiring high expertise on the part of the endoscopist; thus it is currently performed only in some referral centers, and not widely in all geographic areas. A study assessing learning curve showed that a progressive reduction in procedure times and AEs, indicating that a satisfactory level of competence is generally achieved after 25 procedures, while full competence is reached following 40 procedures [67]. The introduction of electrocautery-assisted lumen-apposed metallic stents (Hot-LAMS), which enabled the development of the wireless (or freehand) EUS-GE technique, was an advantage in reducing the number of procedural steps. However, the operator’s skill with the wireless technique remains a critical factor in ensuring safety and optimal results. Finally, a limitation of our systematic review is that nearly half of the considered studies were retrospective in nature, which may have produced biases [15].

In conclusion, the data from this comprehensive review showed that, in referral centers, EUS-GE appears to be a viable approach for the treatment of patients with GOO, for both malignant and benign diseases, with favorable efficacy outcomes and an acceptable safety profile.

Summary Box

What is already known:

  • Gastric outlet obstruction (GOO) is generally treated with a surgical approach

  • Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) with lumen-apposing metal stents was recently introduced to treat patients with GOO

What the new findings are:

  • This comprehensive systematic review showed that EUS-GE is feasible in more than 95% of patients, with clinical success achieved in 93.5% of these cases

  • No difference in either technical and clinical success rate emerged between patients treated for malignant or benign conditions

  • Adverse events overall occurred in almost 20% of patients, with a procedure-related mortality of 1.4%

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Notes

Conflict of Interest: None