Optimal endoscopic drainage strategy for concomitant biliary and gastric outlet obstruction: a multicenter retrospective study (ENDO-GOBO)

Abstract

Background:

Concomitant malignant gastric outlet obstruction (MGOO) and malignant biliary obstruction (MBO) represent a challenging clinical scenario in which the optimal endoscopic strategy remains unclear.

Objectives:

This study aimed to compare real-life combinations of endoscopic ultrasound-guided biliary drainage—hepatogastrostomy (EUS-HGS) or choledochoduodenostomy (EUS-CDS)—with gastric outlet obstruction management—EUS-guided gastroenterostomy (EUS-GE) or enteral stenting (ES).

Design:

This was an international multicenter retrospective cohort study involving 11 tertiary centers (2017–2023).

Methods:

Consecutive patients with MBO and MGOO were included. All patients underwent both biliary and gastric outlet drainage using one of four combinations: EUS-HGS/EUS-GE, EUS-HGS/ES, EUS-CDS/EUS-GE, or EUS-CDS/ES. The primary outcome was stent dysfunction (biliary or digestive). Secondary outcomes included clinical success and adverse events.

Results:

A total of 159 patients were included (median age 70 years; pancreatic cancer 64.8%). Stent dysfunction occurred in 12.0% of patients treated with EUS-HGS/EUS-GE versus 26.6% with EUS-CDS/ES, 36.7% with EUS-HGS/ES, and 50.0% with EUS-CDS/EUS-GE (p = 0.059). At 12 months, stent obstruction-free survival was significantly higher with EUS-HGS/EUS-GE (84.0%) compared with EUS-CDS/ES (51.2%, p = 0.0466), EUS-CDS/EUS-GE (42.0%, p = 0.0377), and EUS-HGS/ES (52.3%, p = 0.0512). Severe adverse events were more frequent with EUS-HGS (15.0% in HGS/ES; 8.0% in HGS/EUS-GE) compared with EUS-CDS (1.6% in CDS/ES; 0% in CDS/EUS-GE; p = 0.014).

Conclusion:

In malignant obstruction, the choice of gastric outlet strategy appears to markedly influence biliary stent patency. When EUS-GE is performed, EUS-HGS may provide superior durability but at the cost of higher morbidity. Conversely, when ES is selected, EUS-CDS appears safer. These findings support a tailored approach integrating anatomical considerations and center expertise when selecting the optimal endoscopic double-drainage strategy.

Plain language summary

Which endoscopic drainage strategy works best when both the bile duct and the stomach outlet are blocked by cancer? A large international study comparing four minimally invasive treatments

Cancers of the pancreas or bile ducts can block two important pathways in the digestive system: the bile duct, preventing bile from flowing normally, and the outlet of the stomach, preventing food from passing into the intestine. When both blockages occur together, patients often experience jaundice, vomiting, weight loss, and are unable to continue chemotherapy. This situation is very difficult to manage, and doctors must decide how to drain both areas using minimally invasive endoscopic procedures. Today, several techniques are available thanks to endoscopic ultrasound (EUS). However, until now, doctors did not know which combination of procedures worked best or offered the longest-lasting results. In this international study, we analysed 159 patients treated in 11 hospitals in France, Canada, and the United States. Each patient received one biliary drainage technique (either EUS-guided hepaticogastrostomy or EUS-guided choledochoduodenostomy) and one treatment for the stomach outlet (either EUS-guided gastroenterostomy or enteral stenting). We found that the combination of hepaticogastrostomy plus EUS-guided gastroenterostomy resulted in the fewest long-term problems and the lowest need for repeat procedures. This combination kept the bile duct and stomach outlet open the longest. However, this approach also carried a slightly higher risk of complications, meaning it may not be suitable for all patients—especially those who are very frail or have fluid in the abdomen (ascites). When a standard metal stent was used to open the stomach outlet, choledochoduodenostomy appeared to be a safer choice for draining the bile duct. Overall, our study shows that the choice of treatment for the stomach outlet has a direct impact on how well the bile duct drainage will work. These results can help doctors personalize treatment plans based on the patient’s condition, expected survival, and the expertise of each medical center.

Keywords

biliary stenosis EUS-CDS EUS-GJ GOBO hepaticogastrostomy therapeutic endoscopic ultrasound

Introduction

The incidence of biliary-pancreatic malignancies is rising significantly.¹ These tumors often result in malignant biliary obstruction (MBO) and gastric outlet obstruction (GOO), affecting 60%–80% and 20%–25% of cases, respectively.^2,3 When these clinical conditions occur simultaneously, the disease is generally at an advanced stage, necessitating a palliative approach. Therefore, therapeutic strategies should be as minimally invasive as possible to improve the patient’s quality of life and enable continued systemic oncological treatment.

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for managing MBO. However, its efficacy is diminished in cases with concurrent malignant GOO (MGOO), leading to higher rates of procedural failure.⁴ Given its comparable technical and clinical success rates, EUS-guided biliary drainage, through EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided hepaticogastrostomy (EUS-HGS), is now recognized as the primary alternative.⁵ While EUS-guided biliary drainage has a technical success rate similar to that of percutaneous transhepatic biliary drainage, it offers a higher clinical success rate and a lower incidence of adverse events, making it the preferred technique.^5,6

On the other hand, treatment of MGOO with enteral stenting (ES) is associated with a high rate of reintervention. The development of EUS-guided gastroenterostomy (EUS-GE) appears promising in addressing this issue because it provides a higher clinical success rate with fewer reinterventions and is less invasive than surgical treatment.⁷

Concomitant gastric outlet and biliary obstruction (GOBO) is a complex condition that may limit certain therapeutic options. To date, only a few small retrospective studies have investigated this condition,^8
–13 but the recent development of EUS-guided procedures is now changing treatment strategies.

Therefore, the aim of our study was to analyze and compare various procedural combinations in the context of GOBO.

Patients and methods

Study design

We conducted an international multicenter retrospective study involving 11 tertiary centers across three countries: France (n = 9), Canada (n = 1), and the United States (n = 1).

Selection criteria

All consecutive patients presenting with distal MBO and malignant gastric outlet obstruction (MGOO) who underwent a combination of biliary drainage (either EUS-CDS or EUS-HGS) and GOO management (either EUS-GE or ES) between 2017 and 2023 were eligible for inclusion.

Patients with hilar or perihilar biliary obstruction (including perihilar cholangiocarcinoma or gallbladder cancer with hilar involvement) were not included, ensuring that EUS-CDS was technically feasible in all cases.

Double endoscopic management was performed concomitantly, with an allowance for a 15-day interval between MGOO and MBO therapeutic management based on the practices of different centers. Patients were excluded if they had undergone prior biliary or GOO management or had a history of surgically altered pancreaticobiliary anatomy.

Patients were followed until death or until they underwent pancreaticoduodenectomy, with a minimum follow-up period of 30 days unless death occurred sooner.

Variability in technique selection

The choice between biliary and gastric outlet drainage techniques was not standardized across centers and reflects the retrospective, real-life nature of the study. Because data were collected over an extended period, therapeutic strategies evolved in parallel with changes in clinical practice. In particular, EUS-GE progressively became the preferred approach for MGOO in several participating centers, replacing ES in routine practice. Similarly, the selection between EUS-CDS and EUS-HGS depended on center-specific expertise and the usual practice patterns of each endoscopy team. Consequently, the distribution of procedures across groups reflects contemporary clinical evolution rather than predefined allocation criteria.

Definitions

Biliary obstruction was defined as the presence of jaundice (bilirubin >50 µmol/L) or abnormal liver function tests that contraindicated continuation of chemotherapy, combined with compatible findings on imaging or endoscopy.

GOO was defined using the GOO Scoring System (GOOSS) as a score of 0 or 1 (indicating no intake or liquids only),¹⁴ along with duodenal stenosis identified on imaging or endoscopy.

Double stenosis was defined as the combination of MBO and MGOO. Fever was defined as a core body temperature exceeding 38.0°C at the time of the biliary drainage procedure.

Ascites was defined as the presence of a small amount of free intra-abdominal fluid detected by cross-sectional imaging (CT or Ultrasound) prior to the procedure, regardless of its location.

The location of duodenal stenosis was classified according to the criteria proposed by Mutignani et al.¹⁵: type I, proximal to the major papilla; type II, involving the major papilla; and type III, distal to the major papilla.

Biliary clinical success was defined as a reduction in bilirubin levels by at least 50% by day 15 or normalization by day 30, or normalization of liver function tests allowing continuation of oncological treatment. Patients who died before day 15 were classified as clinical failures, even if the stent remained patent.

For GOO, clinical success was defined as a post-procedural GOOSS score of ⩾2 at 1 week.

Biliary stent dysfunction was defined as the need for stent cleaning, replacement, or additional stenting following endoscopic or radiologic confirmation of stent occlusion or migration, resulting in cholangitis or elevated bilirubin levels.

Digestive stent dysfunction was defined as the need for additional endoscopic intervention following endoscopic or radiologic confirmation of stent occlusion or migration, resulting in a GOOSS score of 0 or 1.

Stent dysfunction was defined as either biliary or digestive stent dysfunction, whichever occurred first.

Patients requiring additional biliary or GOO management within 15 days were considered to have experienced stent dysfunction but were deemed to have achieved clinical success if they met the specified criteria at 1 month, thanks to the rescue procedure.

Procedure-related adverse events at 1 month were classified according to the AGREE classification, with events considered severe if the AGREE score was ⩾3.¹⁶

In accordance with French legislation on data studies, this study has been approved by the Institutional Review Board (74-2024-11) and the Ethics Committee of Limoges University Hospital. The reporting of this study conforms to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.¹⁷

Procedures

All procedures were performed under general anesthesia or deep sedation.

For EUS-CDS, 6- or 8-mm-diameter lumen-apposing metal stents (LAMSs; Hot Axios; Boston Scientific^®, Marlborough, Massachusetts, USA) were placed between the duodenum and the main bile duct using the free-hand technique.

For EUS-HGS, a 19-G needle was used to puncture the target site before opacification and guidewire placement (0.025-inch Visiglide; Olympus or 0.035-inch Jagwire; Boston Scientific, Tokyo, Japan). A 6-Fr cystotome (Endoflex, Voerde, Germany) was then used to create a tract for placement of a partially covered stent (Giobor, Taewoong^®, or Wallflex; Boston Scientific).

For EUS-GE, 15- or 20-mm LAMSs were inserted using the free-hand technique. The jejunum downstream of the stenosis was dilated, either with a nasobiliary drain inserted beforehand or through endoscope irrigation upstream of the stenosis.

Outcomes

The primary outcome was the rate of stent dysfunction (biliary or digestive) during follow-up. The secondary outcomes were clinical success, median time to stent dysfunction, number of stent dysfunctions, and adverse events as previously defined.

Statistical analysis

Descriptive variables are presented as mean ± standard deviation, and categorical outcomes are presented as absolute and relative (%) frequencies. Group comparability was assessed by comparing the baseline demographic data and follow-up duration between groups. Normality and heteroskedasticity of continuous data were evaluated using the Shapiro–Wilk test and Levene’s test, respectively. Continuous outcomes were compared using analysis of variance, Welch’s analysis of variance, or the Kruskal–Wallis test based on the data distribution. Categorical outcomes were compared using the Chi-squared test or Fisher’s exact test, as appropriate.

The Kaplan–Meier method was used to estimate survival probabilities and their pointwise 95% confidence intervals. Patients were censored at the time of stent dysfunction, the last follow-up date, or death, whichever occurred first. Survival probabilities between groups at 12 months were compared using the Cloglog fixed-point method.

A multivariable logistic regression analysis was conducted to assess the association between stent dysfunction and variables of interest. Multicollinearity was evaluated using the Belsley–Kuh–Welsch technique. Heteroskedasticity and residual normality were tested with the Breusch–Pagan test and the Shapiro–Wilk test, respectively.

To account for the sequential nature of the procedures and eliminate immortal time bias, survival analyses and time-at-risk were anchored to the date of the second procedure (completion of the double-drainage montage). A delayed entry (left-truncation) approach was applied, ensuring that the interval between the first and second interventions did not contribute to the follow-up time. To account for the increased risk of type I error associated with multiple subgroup comparisons, a Bonferroni correction was applied to all p-values in Tables 2 and 3. For these analyses, the significance threshold was adjusted by the number of independent comparisons, and both raw and adjusted p-values are reported to ensure full transparency. The alpha risk for primary and multivariable analyses remained set at 5%. Statistical analysis was performed using EasyMedStat (version 3.36, EasyMedStat, Paris, France).

Results

During the study period, 159 patients who met the inclusion criteria were recruited. Their baseline characteristics are shown in Table 1. Their median age was 70 years (interquartile range: 63.5–79.0 years), and 52.8% were male. Pancreatic cancer was the primary disease in 64.8% of patients. Metastatic disease was present in 55.7% of patients, and 11.8% of patients had ascites.

Table 1.

Overall population characteristics.

Variable	Total (n = 159)
Age (years)—median (Q1–Q3)	70 (63.5–79)
Gender male—n (%)	84 (52.8)
Primary disease—n (%)
Pancreatic cancer	103 (64.8)
Duodenal cancer	13 (8.2)
Ampullary cancer	5 (3.1)
Cholangiocarcinoma	3 (1.9)
Other cancers (metastasis, gallbladder, gastric)	35 (22.0)
Oncological staging—n (%)
Resectable	10 (6.3)
Borderline/locally advanced	44 (27.8)
Metastatic	88 (55.7)
N.A.	16 (6.3)
ASA score—n (%)
1	9 (5.7)
2	48 (30.4)
3	83 (52.5)
4	18 (11.4)
Fever—n (%)	18 (11.3)
Ascites—n (%)	20 (11.8)
Bile duct diameter (mm) (Q1–Q3)	16 (13.1–19)

The characteristics of each treatment group are listed in Table 2. The 159 patients received one of the following treatment combinations: EUS-CDS + EUS-GE (10 patients), EUS-CDS + ES (64 patients), EUS-HGS + EUS-GE (25 patients), or EUS-HGS + ES (60 patients). Apart from differences in the primary disease (p = 0.019), the groups were comparable. The median overall survival was 95 days (35–271 days).

Table 2.

Groups characteristics.

Characteristics	EUS-HGS + ES (n = 60)	EUS-CDS + ES (n = 64)	EUS-HGS + EUS-GE (n = 25)	EUS-CDS + EUS-GE (n = 10)	p-Value	p-Value adj (Bonferroni)
Gender male—n (%)	37 (57.81)	28 (46.67)	13 (52.0)	6 (60.0)	0.622	NS
Age (years)—median (Q1–Q3)	67 (60.75–79)	72.5 (66–79)	73 (66–79)	65.5 (51.25–71.75)	0.051	NS
ASA score—median (Q1–Q3)	3 (2–3)	3 (2–3)	3 (2–3)	3 (2–3)	0.511	NS
Primary disease—n (%)					0.019	0.04
Pancreatic cancer	35 (58.33)	46 (71.88)	14 (56.0)	8 (80.0)
Duodenal cancer	6 (9.38)	6 (10.0)	1 (4.0)	0 (0.0)
Ampullary cancer	1 (1.56)	0 (0.0)	0 (0.0)	1 (10.0)
Cholangiocarcinoma	4 (6.25)	0 (0.0)	2 (8.0)	0 (0.0)
Others^a	19 (31.67)	7 (10.94)	8 (32.0)	1 (10.0)
Metastatic disease—n (%)	35 (58.33)	34 (53.97)	15 (60.0)	4 (40.0)	0.746	NS
Ascites—n (%)	6 (10.0)	10 (15.62)	2 (8.0)	0 (0.0)	0.545	NS
Bile duct diameter (mm) (Q1–Q3)	15 (12–18)	17 (15–20)	14 (11–16)	16 (15–16)	0.007	0.047
Type of “bilioduodenal” stricture					0.132	NS
Type I	46 (76.67)	35 (54.69)	18 (72.0)	6 (60.0)
Type II	9 (15.0)	22 (34.38)	6 (24.0)	4 (40.0)
Type III	5 (8.33)	7 (10.94)	1 (4.0)	0 (0.0)
Follow-up (days)—median (Q1–Q3)	107 (36–166)	88 (34.75–243.25)	86 (27–274.25)	288 (122–359)	0.121	NS
Pancreaticoduodenectomy—n (%)	5 (8.33)	3 (4.69)	0 (0.0)	0 (0.0)	0.507	NS
Oncologic treatment in follow-up—n (%)	32 (55.17)	34 (60.71)	8 (40.0)	7 (87.5)	0.122	NS

Metastasis, gallbladder, gastric neoplasia.

ES, enteral stenting; EUS-CDS, EUS-guided choledocoduodenostomy; EUS-GE, EUS-guided gastroenterostomy; EUS-HGS, EUS-guided hepaticogastrostomy; NS, not significant.

Outcomes of the different treatment combinations are detailed in Table 3.

Table 3.

Outcomes of the different combinations.

Results	EUS-HGS + ES (n = 60)	EUS-CDS + ES (n = 64)	EUS-HGS + EUS-GE (n = 25)	EUS-CDS + EUS-GE (n = 10)	p-Value	p-Value adj (Bonferroni)
Clinical success—n (%)	48 (80.0)	57 (89.06)	24 (96.0)	10 (100.0)	0.144	NS
Biliary	47 (88.33)	58 (90.62)	24 (96.0)	10 (100.0)	0.650	NS
GOO	49 (81.67)	58 (90.62)	25 (100.0)	10 (100.0)	0.052	NS
Stent dysfunction—n (%)	22 (36.67)	17 (26.56)	3 (12.0)	5 (50.0)	0.059	NS
Biliary	11 (18.33)	12 (18.75)	2 (8.0)	4 (40.0)	0.176	NS
GOO	17 (28.33)	9 (14.06)	1 (4.0)	1 (10.0)	0.033	NS
Time to biliary or digestive stent dysfunction (days)—median (Q1–Q3)	67.0 (11.75–298.25)	41 (11.0–105)	35.0 (22.0–56.5)	48.0 (31.0–146.0)	0.571	NS
Adverse events—n (%)	14 (23.33)	12 (18.75)	6 (24.0)	2 (20.0)	0.916	NS
Biliary	12 (20.0)	9 (14.06)	5 (20.0)	1 (10.0)	0.78	NS
GOO	3 (5.0)	3 (4.69)	2 (8.0)	1 (10.0)	0.697	NS
Severe adverse events (AGREE ⩾3)—n (%)	11 (18.33)	4 (6.25)	2 (8.0)	1 (10.0)	0.188	NS
Biliary	9 (15.0)	1 (1.56)	2 (8.0)	0 (0.0)	0.014	0.04
GOO	3 (5.0)	3 (4.69)	0 (0.0)	1 (10.0)	0.434	NS

ES, enteral stenting; EUS-CDS, EUS-guided choledocoduodenostomy; EUS-GE, EUS-guided gastroenterostomy; EUS-HGS, EUS-guided hepaticogastrostomy; GOO, gastric outlet obstruction; NS, not significant.

Clinical success

There were no statistically significant differences in clinical success (p = 0.144) among the four groups.

Stent dysfunction

The EUS-HGS + EUS-GE combination appeared to have the lowest rate of stent dysfunction, with rates as follows: 3/25 (12.00%) for EUS-HGS/EUS-GE, 17/64 (26.56%) for EUS-CDS/ES, 22/60 (36.67%) for EUS-HGS/ES, and 5/10 (50.00%) for EUS-CDS/EUS-GE (p = 0.059; Figure 1).

Figure 1.

Flow chart.

Using the Cloglog fixed-point method, stent obstruction-free survival at 12 months was better with the EUS-HGS/EUS-GE combination (Figure 1):

EUS-CDS/ES: 51.2% (95% CI: 29.3–69.4) versus EUS-HGS/EUS-GE: 84.0% (95% CI: 56.7–94.7), p = 0.0466.

EUS-CDS/EUS-GE: 42.0% (95% CI: 10.7–71.5) versus EUS-HGS/EUS-GE: 84.0% (95% CI: 56.7–94.7), p = 0.0377.

EUS-HGS/ES: 52.3% (95% CI: 31.0–69.9) versus EUS-HGS/EUS-GE: 84.0% (95% CI: 56.7–94.7), p = 0.0512.

During follow-up, some patients required multiple endoscopic procedures. The number of reinterventions needed during follow-up is summarized in Supplemental Figure 1.

The EUS-HGS/EUS-GE combination had the lowest number of reinterventions during follow-up (EUS-HGS/EUS-GE: 0.16 ± 0.46 vs EUS-CDS/ES: 0.34 ± 0.64 vs EUS-HGS/ES: 0.60 ± 0.95 vs EUS-CDS/EUS-GE: 0.70 ± 0.90; p = 0.052).

The median time until biliary stent dysfunction was comparable in the biliary drainage groups (EUS-HGS: 86.0 days (29–288) vs EUS-CDS: 41.5 days (12.75–115.25); p = 0.236).

In cases of biliary stent dysfunction, only three patients in the EUS-CDS group and one patient in the EUS-HGS group required biliary drainage through an alternative route. All other biliary reinterventions were performed through the previous EUS-guided biliary drainage approach. Except for one patient, no coaxial pigtail stents were placed during the initial procedure of EUS-CDS.

Adverse events

All adverse events are listed in Table 4.

Table 4.

Adverse events.

Results	EUS-HGS + ES (n = 60)		EUS-CDS + ES (n = 64)		EUS-HGS + EUS-GE (n = 25)		EUS-CDS + EUS-GE (n = 10)		p-Value	p-Value adj (Bonferroni)
Adverse events—n (%)	14 (23.33)		12 (18.75)		6 (24.0)		2 (20.0)		0.916	NS
Biliary	12 (20.0)		9 (14.06)		5 (20.0)		1 (10.0)		0.78	NS
GOO	3 (5.0)		3 (4.69)		2 (8.0)		1 (10.0)		0.697	NS
Severe adverse events (AGREE ⩾3)—n (%)	11 (18.33)		4 (6.25)		2 (8.0)		1 (10.0)		0.188	NS
Biliary	9 (15.0)		1 (1.56)		2 (8.0)		0 (0.0)		0.014	0.04
GOO	3 (5.0)		3 (4.69)		0 (0.0)		1 (10.0)		0.434	NS
Grade AGREE—n (%)	Biliary	Digestive	Biliary	Digestive	Biliary	Digestive	Biliary	Digestive
I	0 (0.0)	0 (0.0)	1 (1.56)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
			-1 perforation
II	2 (3.33)	1 (1.67)	7 (10.94)	0 (0.0)	3 (12.0)	2 (8.0)	1 (10.0)	0 (0.0)
	-1 infections	-Aspiration pneumonia and severe hydro	-4 infections		-2 infections	-1 prolonged hospitalization for pain	-1 perforation
	-1 prolonged hospitalization for pain	-electrolytic disorder	-2 perforations		-1 prolonged hospitalization for pain	-1 perforation
			-1 bleeding
IIIa	7 (11.67)	1 (1.67)	0 (0.0)	2 (3.13)	1 (4.0)	0 (0.0)	0 (0.0)	0 (0.0)
	-2 bleeding	-1 stent migration		-2 stent migration	-1 bleeding
	-3 bile leak				-1 stent migration
	-3 stent migration
	-1 infection
IIIb	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.56)	0 (0.0)	0 (0.0)	0 (0.0)	1 (10.0)
				-1 perforation				-1 perforation
IVa	0 (0.0)	0 (0.0)	0 (0.0)		0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
IVb	0 (0.0)	0 (0.0)	0 (0.0)		1 (4.0)	0 (0.0)	0 (0.0)	0 (0.0)
					-1 biliary peritonitis
V	2 (3.33)	1 (1.67)	1 (1.56)		0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
	-1 peritoneal stent migration	-1 aspiration pneumonia	-1 AXIOS in pancreatic duct
	-1 severe sepsis

ES, enteral stenting; EUS-CDS, EUS-guided choledocoduodenostomy; EUS-GE, EUS-guided gastroenterostomy; EUS-HGS, EUS-guided hepaticogastrostomy; GOO, gastric outlet obstruction; NS, not significant.

The adverse event rate at 1 month was similar across the groups. However, significantly more severe biliary adverse events occurred when EUS-HGS was performed (9/60 (15.0%) in the EUS-HGS/ES group vs 2/25 (8.0%) in the EUS-HGS/EUS-GE group vs 1/64 (1.56%) in the EUS-CDS/ES group vs 0/10 (0.0%) in the EUS-CDS/EUS-GE group; p = 0.014).

Four deaths were recorded in connection with the endoscopic procedure: one due to peritoneal stent migration, one due to severe sepsis, one due to aspiration pneumonia, and one following AXIOS stent placement in the pancreatic duct.

Digestive stent dysfunction only

The use of an EUS-GE-based combination significantly reduced the incidence of digestive stent dysfunctions (p = 0.033; Figures 2 –4).

Figure 2.

Stent obstruction-free survival.

Figure 3.

GOO recurrence-free survival.

Figure 4.

Cox proportional hazards regression analysis for the composite outcome (stent dysfunction or death).

Kaplan–Meier analysis showed a significant difference in recurrence-free survival distributions between the EUS-GE and ES groups (p = 0.0316). At 12 months, recurrence-free survival was 63.7% (95% CI: 47.3–76.2) for ES and 92.5% (95% CI: 72.8–98.1) for EUS-GE (p = 0.021).

Factors affecting all stent dysfunction

In the multivariable analysis (Table 5), a stricture involving the papilla (HR, 0.286 (0.104–0.788)) was independently associated with a reduced risk of stent dysfunction. In the multivariable analysis, using the EUS-HGS + EUS-GE combination as the reference group, both the EUS-CDS + EUS-GE (OR, 7.9; 95% CI (1.29–48.56)) and EUS-HGS + ES (OR, 4.03; 95% CI (1.05–15.44)) combinations were identified as independent risk factors for biliary stent dysfunction.

Table 5.

Multivariable analysis of factors affecting stent dysfunction.

	Odds ratio	p-Value
Procedure combination
EUS-HGS + EUS-GE	1
EUS-CDS + EUS-GE	7.9 (1.29; 48.56)	0.0256*
EUS-CDS + ES	3.35 (0.847; 13.21)	0.0848
EUS-HGS + ES	4.03 (1.05; 15.44)	0.0419*
Type of “bilioduodenal” stricture
Type I	1
Type II	0.286 (0.104; 0.788)	0.0155*
Type III	0.713 (0.197; 2.59)	0.607

ES, enteral stenting; EUS-CDS, EUS-guided choledocoduodenostomy; EUS-GE, EUS-guided gastroenterostomy; EUS-HGS, EUS-guided hepaticogastrostomy.

indicates a statistically significant difference (p < 0.05).

Discussion

Our study suggests that the combination of EUS-HGS and EUS-GE provides a high rate of durability in this challenging context, with a reintervention rate of 8% for biliary obstruction and 4% for digestive obstruction. By contrast, the combination of EUS-CDS and EUS-GE was associated with the highest numerical reintervention rate (50%). However, this observation must be interpreted with caution; due to the small sample size of this specific subgroup (n = 10), this finding should be considered a clinical trend that confirms observations from other small cohorts, such as Vanella et al., rather than a definitive statistical conclusion.

In the management of MBO, EUS-guided drainage techniques have significantly impacted clinical practice. While ERCP remains the gold standard, duodenal stenosis or invasion is a major cause of failure. Even when ERCP succeeds, duodenal involvement increases the risk of trans-papillary stent obstruction,⁴ and reintervention can be complex or impossible in cases of disease progression. For these reasons—efficacy, patency, and reintervention—EUS-guided biliary drainage is becoming the preferred treatment for patients with GOBO, occurring in up to 25% of pancreatic head tumors.¹⁸ Yet, the optimal endoscopic approach remains uncertain. Few studies have focused on GOBO. The main study, by Vanella et al.,¹³ reported favorable outcomes with EUS-HGS and EUS-GE, though in only six patients. The EUS-CDS and EUS-GE combination was also linked to a high biliary dysfunction rate (31.2%), similar to our series. These findings were prospectively confirmed in just 20 patients by the same team.¹⁹

Several publications have already identified the presence of duodenal stenosis as an established risk factor for biliary LAMS dysfunction in the case of EUS-CDS.^20,21 Our study confirmed this finding, regardless of the treatment used for duodenal stenosis—whether with a stent or EUS-GE. The most widely accepted mechanical explanation for recurrent cholangitis is food stagnation in the duodenum upstream of the stenosis. This stagnation, which EUS-GE does not resolve despite alleviating symptoms, contributes to biliary obstruction. However, in previous studies,²² among patients who initially received EUS-CDS for biliary drainage and later developed GOO, EUS-GE did not result in a higher risk of biliary stent dysfunction compared to ES. Instead, it showed better outcomes in terms of sustained relief from GOO symptoms. This suggests that the combination of these procedures may not be the only factor influencing outcomes. Some teams have suggested that adding a coaxial pigtail stent could reduce EUS-CDS obstruction.²³ In our series, however, the only patient with a preventive coaxial pigtail drain experienced biliary obstruction.

Interestingly, when GOO was managed with duodenal stents, our results showed no difference in biliary patency between the EUS-guided biliary drainage procedures (EUS-HGS vs EUS-CDS).

Our study also confirmed the superiority of EUS-GE over duodenal stenting for MGOO. Historically, the SUSTENT trial demonstrated that although ES offered faster short-term clinical improvement, it was associated with more frequent symptom recurrence and reinterventions compared to surgery.²⁴ As recent randomized controlled trials have corroborated findings from retrospective cohorts, and with the ENDURO trial further establishing EUS-GE as a highly effective alternative to surgical gastrojejunostomy, EUS-GE is increasingly becoming the standard of care for GOO.^25
–27,28 If EUS-GE becomes the standard, the numerical trend toward higher EUS-CDS dysfunction observed in our study, when combined with EUS-GE, suggests that EUS-HGS might be considered as a potentially more durable biliary drainage approach in cases of concomitant obstruction. However, this potential gain in durability must be weighed against the safety profile of the biliary drainage route. In our cohort, EUS-HGS was associated with a higher rate of severe adverse events (15.0%) compared to EUS-CDS, primarily due to bile leaks and peritonitis. These findings highlight the technical complexity of the transhepatic approach and suggest that while EUS-HGS may be the preferred option for ensuring long-term biliary patency in patients with a longer life expectancy, it requires high-endoscopic expertise to mitigate the risk of immediate post-procedural complications.

Although most patients with GOBO are at an advanced stage—as shown by our population, with more than 55% having metastatic disease—what strategy should be employed for patients with a potential surgical plan?

Initially, there was some hesitation about performing extra-anatomical biliary drainage via EUS (CDS or HGS) in patients with surgical plans. However, emerging data suggest this approach can be considered if ERCP is unfeasible or has failed.^29
–31

Additionally, EUS-GE has shown improvements in clinical response and may enhance nutritional outcomes, which is essential for the medical management of these patients. Surgical resection appears feasible after EUS-GE,³² although further data are still needed. Adverse events must also be considered; we found a significantly higher rate of severe adverse events in the EUS-HGS groups.

While optimizing the nutritional status and biliary drainage is reasonable—especially because advances in oncology are extending life expectancy for these patients³³—the increased risk of morbidity must not be overlooked, particularly for those with advanced disease, comorbidities, or limited life expectancy (<3 months). In these cases, EUS-CDS with LAMS combined with duodenal stenting may remain a safer option. New devices, such as LAMS dedicated specifically to EUS-HGS, are expected to be available soon and may simplify this procedure while reducing complication risks in the near future.

The limitations of this study include its retrospective design, variability in practices across centers, and uneven distribution of biliary drainage routes. In addition, the EUS-GE/EUS-CDS group had a small sample size, though outcomes were consistent with those reported by Vanella et al.,¹³ supporting the likely increased risk of LAMS dysfunction in this context. Furthermore, as a retrospective study, the choice of the endoscopic strategy was at the endoscopist’s discretion and may have been influenced by individual preference, anatomical considerations, or the era of the procedure. While this introduces a potential selection bias, the baseline characteristics in Table 1 were mostly comparable between groups. This suggests that the higher rate of severe adverse events noted in the EUS-HGS group likely reflects the inherent technical difficulty of this technique rather than a bias toward more complex cases. Another limitation is the exclusion of transpapillary stenting. In participating expert centers, ERCP was rarely performed, except in specific cases of type III obstruction (only 8% of patients). The absence of percutaneous transhepatic drainage may raise questions; however, current data support the superiority of EUS-guided biliary drainage in clinical success, adverse events, and quality of life.

The strengths of this study include the substantial sample size, with more than 150 cases of concurrent obstruction, as well as the even distribution between the EUS-HGS (85 patients) and EUS-CDS groups (74 patients), unlike previous studies. In addition, procedures were conducted by 22 physicians across 11 centers, minimizing expertise bias because each physician performed either HGS, CDS, or both in this study.

Conclusion

Managing malignant GOBO is a complex clinical challenge. Our study suggests that the choice of GOO management may influence the durability of the biliary drainage strategy. While limited by small subgroup sizes, we observed a numerical trend suggesting that EUS-HGS may offer better long-term patency when combined with EUS-GE, whereas EUS-CDS appears to be a viable alternative when ES is used. These findings, which align with preliminary data from other cohorts, should be confirmed by larger prospective studies. A tailored approach, considering patient anatomy and local expertise, remains essential for optimizing palliative outcomes.

Supplemental Material

sj-docx-1-tag-10.1177_17562848261446493 – Supplemental material for Optimal endoscopic drainage strategy for concomitant biliary and gastric outlet obstruction: a multicenter retrospective study (ENDO-GOBO)

Supplemental material, sj-docx-1-tag-10.1177_17562848261446493 for Optimal endoscopic drainage strategy for concomitant biliary and gastric outlet obstruction: a multicenter retrospective study (ENDO-GOBO) by Thomas Beuchard, Jean-Philippe Ratone, Marion Schaefer, Marc Barthet, Thomas Guilmoteau, Timothée Wallenhorst, Sharif Yassin, Farimah Fayyaz, Enrique Perez-Cuadrado-Robles, Antoine Debourdeau, Sarah Leblanc, Romain Legros, Hugo Lepetit, Martin Dahan, Fabrice Caillol, Marc Giovannini, Jean-Baptiste Chevaux, Ivann Bouteiller, Mohamed Gasmi, Diane Lorenzo, Laurent Poincloux, Thomas Grainville, Yen-I Chen, Mouen Khashab, Vincent Lepilliez, Bertrand Napoleon, Marco Spadaccini, Yanis Dahel, Jean-Michel Gonzalez, Jérémie Jacques and Jérémie Albouys in Therapeutic Advances in Gastroenterology

Supplemental Material

sj-docx-2-tag-10.1177_17562848261446493 – Supplemental material for Optimal endoscopic drainage strategy for concomitant biliary and gastric outlet obstruction: a multicenter retrospective study (ENDO-GOBO)

Supplemental material, sj-docx-2-tag-10.1177_17562848261446493 for Optimal endoscopic drainage strategy for concomitant biliary and gastric outlet obstruction: a multicenter retrospective study (ENDO-GOBO) by Thomas Beuchard, Jean-Philippe Ratone, Marion Schaefer, Marc Barthet, Thomas Guilmoteau, Timothée Wallenhorst, Sharif Yassin, Farimah Fayyaz, Enrique Perez-Cuadrado-Robles, Antoine Debourdeau, Sarah Leblanc, Romain Legros, Hugo Lepetit, Martin Dahan, Fabrice Caillol, Marc Giovannini, Jean-Baptiste Chevaux, Ivann Bouteiller, Mohamed Gasmi, Diane Lorenzo, Laurent Poincloux, Thomas Grainville, Yen-I Chen, Mouen Khashab, Vincent Lepilliez, Bertrand Napoleon, Marco Spadaccini, Yanis Dahel, Jean-Michel Gonzalez, Jérémie Jacques and Jérémie Albouys in Therapeutic Advances in Gastroenterology

Footnotes

Acknowledgements

The authors would like to thank Ramziath Mama Kossou Karim.

Authors’ note

The English in this document has been checked by at least two professional editors, both native speakers of English. For a certificate, please see: .

Declarations

ORCID iDs

Antoine Debourdeau

Jérémie Albouys

Supplemental material

Supplemental material for this article is available online.

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