Interventional procedure overview of endoscopic ultrasound-guided biliary drainage for biliary obstruction
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Evidence summary
Population and studies description
This overview is based on 2,644 patients from 1 systematic review and meta-analysis, 1 RCT, 1 non-randomised comparative study, 5 case series and 1 case report. Of these 2,644 patients, 2,533 patients had the procedure. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 9 studies as the key evidence in table 2 and table 3, and lists 78 other relevant studies in table 5. Due to the large body of evidence for this procedure, studies that met the criteria but had less than 50 patients were not included in table 5.
The studies were done in Italy, the UK, Ireland, the USA, France, Ecuador, Spain, India, Brazil, South Korea, Germany and Japan. The systematic review was done in the USA but locations of included studies were not reported. Of the case series reported, 4 were retrospective and 1 was prospective, and the single non-randomised comparative study included was prospective.
The study from Fugazza (2022) was a multicentre analysis of 256 people with jaundice caused by DMBO who had EUS-CDS after ERCP failure. The case series from On (2022) was a multicentre review of EUS-CDS in 120 consecutive patients with DMBO. An additional case series of 205 patients who had EUS‑HGS looked at the procedure specifically in the context of malignant biliary obstruction (Marx 2022). A case report highlighted an adverse event which occurred after EUS-HGS in a person with pancreatic adenocarcinoma (Takahashi 2022).
There was also 1 RCT of 125 people which compared EUS-BD and ERCP safety and efficacy in people with unresectable malignant distal biliary obstruction (Paik 2018).
The systematic review from Dhindsa (2022) included 1,437 patients who had EUS-BD across 23 studies and did not exclude studies on the basis of benign or malignant biliary obstruction.
The prospective non-randomised comparative study of 182 people (Tyberg 2022) comparing EUS-CDS and EUS-HGS, which recruited people from the USA, Brazil, India, Ecuador, France and Spain, did not specifically exclude cases of benign biliary obstruction. But, in the final analysis 91% (165/182) of included people had malignant biliary obstruction as an indication.
Two studies looked at people with biliary obstruction because of benign causes. The case series of 215 people from Hathorn (2022) was a retrospective single-centre study in the USA which compared EUS-guided transhepatic biliary drainage outcomes in populations with benign and malignant causes of biliary obstruction. The case series of 103 people from Fuldner (2021) was a single-centre study which also examined the efficacy and safety of EUS-BD after failed ERCP in people with benign biliary obstruction.
Follow-up of all key studies ranged from a median of 70 days to a mean of 257 days; however, study follow-up was not reported in the systematic review and meta-analysis or the case report. The mean age of patients ranged from 62.9 years to 73.4 years.
Table 2 presents study details.
Study no. | First author, date country | Patients (male: female) | Age (years) | Study design | Inclusion criteria | Intervention | Follow up |
|---|---|---|---|---|---|---|---|
1 | Dhindsa 2020 (SR+MA done in USA, countries not reported for included studies) | 1,437 (774:663) | Mean 67 | Systematic review and meta-analysis | Cohort studies looking at EUS-BD with information on adverse events, subcategories of adverse events, technical success rate, and clinical success rate. | EUS-BD (transgastric 29.5%, transduodenal 34.4%, other techniques 19.8%) | Not reported |
2 | Fugazza 2022 Italy | 256 (141:115) | Mean 73.4 | Case series | Patients with jaundice caused by DMBO after ERCP failure. | EUS-CDS | Mean 151±162 days |
3 | On 2022 UK and Ireland | 120 (66:54) | Mean 73 | Case series | Patients with DMBO | EUS-CDS | Median 70 days (range 3 to 869) |
4 | Hathorn 2022 USA | 215 (101:114) (130 malignant, 85 benign) | Mean 62.9 | Case series | Patients who had EUS-guided transhepatic biliary drainage | EUS-HGS | Mean 257.31 ± 308.11 days (124.53± 229.86 days for benign disease, 457.27 ± 466.31 days for malignant disease) |
5 | Marx 2022 | 205 (104:101) | Mean 68 | Case series | Patients that had EUS-HGS between 2002 and 2018 for malignant biliary obstruction | EUS-HGS | Median 6.4 months (95% CI 4.1 to 10 months) |
6 | Tyberg 2022 USA, France, Ecuador, Spain, India, Brazil | 182 (93:89) (95 EUS-HGS versus 87 EUS-CDS) | Mean 70 | Non-randomised comparative study | Patients with biliary obstruction with prior failed ERCP who had EUS-HGS or EUS-CCD; at least 6-month follow-up data or death within 6 months. | EUS-HGS and EUS-CDS | 6 months or until death |
7 | Paik 2018 South Korea | 125 (67:58) (64 EUS-BD versus 61 ERCP) | Mean 66.8 | RCT | Presence of unresectable malignant distal biliary obstruction (>2 cm distal to the hilum) with patholologic or radiologic diagnosis prior to endoscopic intervention; >18 years old; a Karnofsky index of 30% or greater, no serious or uncontrolled coexisting medical illness. | EUS-BD (EUS-CDS 50%, EUS-HGS 50%) and ERCP | Median 155 days (IQR 100 to 234 days) |
8 | Fuldner 2021 Germany | 103 | 66 | Case series | Patients with benign biliary obstruction and previously failed ERCP. | EUS-BD (transgastric 70%, transduodenal 16%, transjejuneal 14%) | Not reported |
9 | Takahashi 2022 Japan | 1 (female) | 77 | Case report | - | EUS-HGS | Not reported |
Procedure technique
Of the 9 studies included, 8 specified the exact technique used; the systematic review specified the proportion of interventions that were transgastric, transduodenal or used another route, but was not more specific (Dhindsa 2020).
Of the remaining 8 studies, 6 studies used EUS-HGS, and 5 studies used EUS‑CDS (3 studies used both techniques). The case series of 103 people used multiple stenting techniques in addition to EUS-HGS and EUS-CDS which included EUS-RV and antegrade internal drainage (Fuldner 2021).
A variety of plastic and metal stents were used in the key evidence papers, but the most commonly named stents were the HotAXIOS stents (Boston Scientific), and the Hanarostent (MiTech), which were each named in 2 of the 9 studies.
Efficacy
Technical success
Technical success was reported in 7 studies. In the systematic review and meta-analysis of 1,437 people, the pooled rate of technical success (defined as successful stent deployment) was 92% (95% CI 87.7% to 94.2%; n=23 studies; I2= 76.5%; Dhindsa 2020).
In the case series of 256 people with jaundice caused by DMBO, the rate of technical success (defined as successful stent placement) of EUS-CDS was 93% (239/256; Fugazza 2022).
In the case series of 120 people with DMBO, the technical success rate of EUS‑CDS (defined as successful stent placement) was 91% (109/120; On 2022).
In the case series of 215 people, overall technical success rate of transhepatic EUS-BD was 95% (204/215). When split by indication, reported technical success in malignant patients was 97% (126/130) and technical success in benign patients was 92% (78/85; Hathorn 2022).
In the non-randomised comparative study of 182 people, technical success was 92% for both EUS-CDS (80/87) and EUS-HGS (87/95; Tyberg 2022).
In the RCT of 125 people, technical success of EUS-BD was 94% (60/64) and was comparable to ERCP technical success of 90% (55/61); difference 3.6% (95% CI -4.4% to 11.6%, p=0.003 for noninferiority between procedures; Paik 2018).
In the case series of 103 people with benign biliary obstruction, the technical drainage success rate was 96% (99/103) and stent placement rate was 86% (85/99; Fuldner 2021).
Clinical success
Clinical success, largely defined by reduction in bilirubin serum levels, was reported in 7 studies. In the systematic review and meta-analysis of 1,437 people, the pooled rate of clinical success (defined in most included studies as a reduction in serum total bilirubin by 50% at 1 week or <3 mg/dL at 2 weeks after the procedure) was 87% (95% CI 82.3% to 90.6%; n=21 studies; I2= 72.4%; Dhindsa 2020).
In the case series of 256 people with jaundice caused by DMBO, the proportion of people with a decrease in bilirubin levels of at least 50% within 2 weeks of EUS-CDS was 96% (230/239). The mean percentage decrease in bilirubin levels decreased by 72% to 4.11 mg/dL ± 3.96 mg/dL 2 weeks after the procedure from an initial baseline of 14.7 mg/dL ± 7.11 mg/dL (p<0.001; Fugazza 2022).
In the case series of 120 people, decrease in bilirubin levels of at least 50% within 2 weeks of procedure was 95% (92/97). The median serum bilirubin levels 2 weeks after procedure were 76.5 micromoles/litre (range 8 to 352) compared with 222.5 micromoles/litre (range 45 to 687) at baseline (p<0.001; On 2022).
In the case series of 215 people, clinical success (defined by an appropriate reduction in serum bilirubin – exact threshold not reported) was 87% (89/102) across all patients in which this outcome data was available. When split by indication, clinical success in malignant patients was 86% (63.72) and clinical success in benign patients was 90% (27/30; Hathorn 2022).
In the case series of 205 people, the proportion of people with either >50% decrease in plasma bilirubin 1 month after procedure or sufficient improvement in health for discharge was 93% (143/153) in patients with available data (Marx 2022).
In the non-randomised comparative study of 182 people, clinical success (defined as relief of cholangitis, jaundice, or pruritus with at least a 30% decrease in pre-treatment bilirubin level within a week of placement or normalisation of bilirubin within 30 days) was 86% (75/87) in EUS-HGS and 100% in EUS-CDS (80/80; Tyberg 2022).
In the RCT of 125 people, clinical success of EUS-BD was 90% (54/60); compared to ERCP which had clinical success of 95% (52/55), there was no statistically significant difference (p=0.49; Paik 2018).
Rate of reintervention
Rates of reintervention were reported in 8 studies. In the systematic review and meta-analysis of 1,437 people, the pooled rate of reintervention was 7% (95% CI 3.8% to 10.8%; n=19 studies; I2= 69.3%; Dhindsa 2020).
The rate of reintervention was 9% (22/239) in the case series of 256 people with DMBO (Fugazza 2022), 8% (9/109) in the case series of 120 people with DMBO (On 2022), and 19% (19/103) in the case series of 103 people with benign biliary obstruction (Fuldner 2021).
In the case series of 215 people, 17% (22/126) of patients with malignant disease with 6-month follow-up required reintervention (Hathorn 2022).
In the case series of 205 people, 36% (47/130) of people experienced recurrent biliary obstruction requiring reintervention, with a mean number of 1.7 reinterventions per patient (Marx 2022).
In the non-randomised comparative study of 182 people, the rate of re-stenting was 29% (25/87) for EUS-HGS and 10% (8/80) for EUS-CDS; this difference in rate of re reintervention between EUS-BD techniques was statistically significant (p=0.01; Tyberg 2022).
In the RCT of 125 people, there was a statistically significant lower rate of rate of reintervention for EUS-BD in ITT analysis compared to ERCP (16% [10/64] versus 43% [26/61], p=0.001; Paik 2018).
Stent patency
Stent patency was reported in 3 studies. In the case series of 205 people, mean stent patency duration was 153±433 days (Marx 2022).
In a non-randomised comparative study of 182 people, EUS-CDS was 4.5 times more likely than EUS-HGS to achieve longer stent patency (>30 days) or manage obstruction (OR 4.5 [95% CI 1.15 to 17.65], p=0.0302; Tyberg 2022).
In an RCT of 125 people, stent patency at 6 months according to Kaplan–Meier estimation was 85% for EUS-BD and 49% for ERCP, with a statistically significant difference in stent patency between the 2 techniques (p=0.001; Paik 2018).
Survival
Survival and mortality was reported in 4 studies. In the case series of 215 people, 51% (66/130) of people with malignant biliary obstruction died within a mean follow-up period of 457 days because of progressive disease, and 9% (8/85) people with benign disease died during a mean follow-up of 125 days due to causes unrelated to the procedure (Hathorn 2022).
In the case series of 205 people with malignant biliary obstruction, the median survival was 5.3 months (95% CI 2.9 to 7.5 months), and 15% (30/205) patients died within 30 days of the procedure (Marx 2022).
In the non-randomised comparative study of 182 people, 42% (77/182) survived for at least 6 months following the procedure (Tyberg 2022).
In the RCT of 125 people, the median overall survival according to Kaplan–Meier estimation was 178 days for EUS-BD and 144 days for ERCP, with no statistically significant difference between the two (p=0.92). In the ITT analysis, the percentage of deaths due to disease progression was 72% (46/64) for EUS-BD and 84% (51/61) in ERCP (Paik 2018).
Improvement in quality of life
Improvement in quality of life was reported in 1 study. In the RCT of 125 people, quality of life at 12 weeks was assessed using the EORTC QLQ-C30 (scored 1 to 100 for each parameter); there were statistically significant differences between EUS-BD and ERCP in mean change in global functioning (+4.17 EUS-BD versus ‑9.03 ERCP, p=0.001), mean change in emotional functioning (+1.62 EUS-BD versus -9.72 ERCP, p=0.001) and mean change in cognitive functioning (+0.93 for EUS-BD versus -11.11 ERCP, p=0.003), where higher scores in these domains indicate improved quality of life.
In the same study, there were also statistically significant differences in EORTC QLQ-C30 (scored 1 to 100 for each parameter) between EUS-BD and ERCP in mean change in fatigue score (-3.40 for EUS-BD versus +8.02 ERCP, p=0.02), mean change in pain score (-17.59 for EUS-BD versus +4.63 ERCP, p=0.01) and mean change in financial difficulties (+2.78 for EUS-BD versus 18.52 ERCP, p=0.01), where higher scores in these domains indicate worse symptoms or outcomes (Paik 2018).
Safety
Procedural death
Procedure-related death was reported in 1 study. In the case series of 205 people with malignant biliary obstruction, 5% (10/205) of people died of procedure related causes; in 1 person this was due to biliary leakage, in 1 person this was due to severe sepsis, in 1 person this was due to stent obstruction, in 3 people this was due to stent migration, in 1 person this was due to acute kidney injury, in 1 person this was due to acute pulmonary oedema, and in 2 people this was due to a combination of minor complications (Marx 2022).
Perforation
Perforation was reported in 4 studies. Duodenal perforation was reported in 2% (2/120) of people in the case series of 120 people (On 2022). Perforation was also reported in 1 person in the case series of 215 people (Hathorn 2022), in 1 person in the case series of 103 people (Fuldner 2021), and in 2% of people in both EUS-HGS (2/95) and EUS-CDS (3/87) in the non-randomised comparative study of 182 people (Tyberg 2022).
Sepsis
Sepsis was reported in 2 studies. In the case series of 215 people, 2% (5/215) of people had sepsis secondary to cholangitis and 2% (4/215) of people had septic shock (Hathorn 2022). In the case series of 205 people, there was one procedural related death from severe sepsis (Marx 2022).
Biloma
Biloma was reported in 3 studies and a case report. The case report outlined the case of a woman with formation of biloma which then became infected, leading to liver and brain abscesses. This was successfully treated with antibiotics and additional stenting (Takahashi 2022).
Biloma or abscess was reported in 2% (5/215) of people in the case series of 215 people (Hathorn 2022), and biloma was reported in 1 person who had EUS-HGS in the non-randomised comparative study of 182 people (Tyberg 2022).
In the case series of 103 people, 3% (3/103) of people had either biloma or a liver abscess (Fuldner 2021).
Infection
Infection was reported in 4 studies. In the systematic review of 1,437 people, the pooled rate of infection was 4% (95% CI 2.8% to 5.1%, I2 = 0%; Dhindsa 2020)
Infection was also reported in 2% of people in the in the case series of 256 people (Fugazza 2022), and in the non-randomised comparative study of 182 people, infection was reported in 2% (2/95) of patients who had EUS-HGS and 3% (3/87) of patients who had EUS-CDS (Tyberg 2022).
In the case series of 215 people, bacteraemia was reported in 2% (4/215) of people (3 cases in the benign group and 1 in the malignant group), and fungaemia was reported in 1 person. Fever requiring antibiotics was reported in <1% (2/215) of people (Hathorn 2022).
Stent migration
Stent migration was reported in 7 studies. In the systematic review of 1,437 people, the pooled rate of stent migration was 4% (95% CI 2.5% to 6.2%, I2 = 43.5%; Dhindsa 2020).
Stent migration was also reported in <1% of people (2/239) in the case series of 256 people (Fugazza 2022), in 1 person without combined cholangitis and 5% (6/120) of people with combined cholangitis in the case series of 120 people (On 2022), in 10% (20/205) of people (with 3 subsequent deaths) in the case series of 205 people (Marx 2022), in 1 person in the RCT of 125 people (Paik 2018) and in 11% (11/103) of people in the case series of 103 people (Fuldner 2021).
Stent migration was reported in 1 person in the EUS-HGS group and 1 person in the EUS-CDS group in the non-randomised comparative study of 182 people (Tyberg 2022).
Stent occlusion
Stent occlusion was reported in 3 studies. Stent occlusion was reported in 7% (16/239) of people in the case series of 256 people (Fugazza 2022), in 6% (7/120, 6 with combined cholangitis, 1 without cholangitis) of people in the case series of 120 people (On 2022), in 4% (8/205) of people in the case series of 205 people (with 1 subsequent death; Marx 2022).
Cholangitis
Cholangitis without accompanying stent occlusion was reported in 4 studies.
Cholangitis was reported in 7% (5/120) of people in the case series of 120 people (On 2022), 3% (6/215) of people in the case series of 215 people (Hathorn 2022), 2% (5/205) of people in the case series of 205 people (Marx 2022), and in 6% (4/64) of people in the RCT of 125 people (Paik 2018).
In the non-randomised comparative study of 182 people, cholangitis was reported in 2% (2/95) of people who had EUS-HGS, and in 1% (1/87) of people who had EUS-CDS (Tyberg 2022).
Bile leak
Bile leak was reported in 6 studies, including the case report of biloma described above (Takahashi 2022). In the systematic review of 1,437 people, the pooled rate of bile leak was 4% (95% CI 2.7% to 6.2%, I2 = 46.7%; Dhindsa 2020).
Bile leak was also reported in 2% (2/120) of people in the case series of 120 people (On 2022), in 1 person in the case series of 215 people (Hathorn 2022), in 3% (6/205) of people in the case series of 205 people (1 of which led to subsequent death; Marx 2022) and in 3% (3/103) of people in the case series of 103 people (Fuldner 2021).
Bleeding
Bleeding was reported in 5 studies. In the systematic review of 1,437 people, the pooled rate of bleeding was 4% (95% CI 2.3% to 5.3%, I2 = 41.8%; Dhindsa 2020).
Bleeding was also reported in 2% (4/239) of people in the case series of 256 people (3 moderate cases, 1 severe case; Fugazza 2022), in 1 person in the case series of 215 people (Hathorn 2022), in 2% (3/205) of people in the case series of 205 people (Marx 2022), and 6% (6/103) of people in the case series of 103 people (Fuldner 2021).
In the non-randomised comparative study of 182 people, bleeding was reported in 6% (6/95) of people who had EUS-HGS and 3% (3/87) of people who had EUS-CDS (Tyberg 2022).
The case series of 215 people also reported haematemesis in 1 person (Hathorn 2022).
Peritonitis
Peritonitis was reported in 2 studies; in 1 person who had EUS-HGS in the non-randomised comparative study of 182 people (Tyberg 2022), and in 1 person in the RCT of 125 people (Paik 2018).
Pneumoperitoneum
Pneumoperitoneum was reported in 4 studies. In the systematic review of 1,437 people, the pooled rate of pneumoperitoneum was 3% (95% CI 2.3% to 4.6%, I2 = 2%; Dhindsa 2020).
Pneumoperitoneum was also reported in 2% (2/120) of people in the case series of 120 people (On 2022) and in 2% (5/205) of people in the case series of 205 people (Marx 2022). Self-limited pneumoperitoneum was also reported in 3% (2/64) of people in the RCT of 125 people (Paik 2018).
One person in the case series of 120 people experienced retroperitoneal air as a result of the procedure (On 2022).
Pain
Pain was reported in 2 studies; in 3% (6/215) of people in the case series of 215 people (Hathorn 2022), and 2% (2/103) of people in the case series of 103 people (Fuldner 2021).
Other adverse events
Other adverse events were reported in 2 studies. In the case series of 215 people, 1 person reported haemodynamic instability,1 person reported respiratory distress and 1 person reported a Mallory-Weiss tear as a result of postprocedural nausea and vomiting (Hathorn 2022).
In the non-randomised comparative study of 182 people the rate of non-specified adverse events was 5% (5/95) in the EUS-HGS group and 12% (10/87) in the EUS-CDS group (Tyberg 2022).
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they have never happened (theoretical).
For this procedure, professional experts did not describe any additional anecdotal or theoretical adverse events.
Four professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
The total sample size was large (n=2,644), with studies conducted across Europe, Asia, North America and South America; a case series of n=120 conducted in the UK and Ireland was included in the key evidence.
Mean follow up duration was no longer than 257 days; during follow up periods there was significant death across multiple studies largely because of progressive malignant disease. The possibility of conducting further studies with longer follow-up is limited by survival in malignant disease.
The population assessed was largely patients with malignant biliary obstruction (for which there were mixed aetiologies), but there were 2 studies that reported outcomes in patients with benign biliary obstructions (Fuldner 2021; Hathorn 2022).
Quality of life outcomes were only reported in a single study (Paik 2018).
There was significant variation in the types of stents and techniques used in this procedure.
There may be a difference in efficacy and safety between EUS-HGS and EUS-CDS but the evidence is limited and non-conclusive.
The procedural deaths specified in the adverse events all occurred in a single study of people with malignant biliary obstruction (Marx 2022).
The systematic review and meta-analysis reported significant heterogeneity across studies and risk of publication bias (Dhindsa 2020).
5 studies reported conflicts of interest (Fugazza 2022, Hathorn 2022, Marx 2022, Tyberg 2022, On 2022). These conflicts involved editorial responsibility in the publishing journal (Tyberg 2022), and consultancy or speaker fees for manufacturers of the devices used in the procedure (Fugazza 2022, Hathorn 2022, Marx 2022, Tyberg 2022, On 2022)
Multiple studies (Dhindsa 2020, Fugazza 2022, Hathorn 2022, Marx 2022) specify that the results may be impacted by the learning curve of the procedure.
There are numerous ongoing studies relating to the procedure, including those listed below:
EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction (NCT03870386); RCT; Canada; estimated enrolment n=144; study start date March 2019; estimated study completion date March 2023
Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicentre randomised controlled trial (UMIN000041343); RCT; Japan; estimated enrolment 95; study start date September 2020; estimated study completion date October 2022.
EUS-guided Biliary Drainage With EC-LAMS vs ERCP as a Primary Intervention for Endoscopic Treatment of Patients With Distal Malignant Biliary Obstruction (NCT04099862); observational cohort study; Italy; estimated enrollment n=220; study start date February 2021, estimated study completion date December 2022
Multicentre, Randomised and Comparative Study of Lumen-apposing Metal Stents With or Without Coaxial Plastic Stent for Endoscopic Ultrasound-guided Transmural Biliary Drainage (NCT04595058); RCT; Spain; estimated enrolment n = 60; study start date November 2022; estimated study completion date November 2023.
Comparison of Efficacy and Safety of Endoscopic Biliary Drainage and Percutaneous Transhepatic Biliary Drainage for the Management of Perihilar Malignant Biliary Obstruction: a Monocentric Retrospective Study (NCT05078801); observational cohort study; France; estimated enrolment n=100; study start date July 2021; estimated study completion date October 2022
Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus Endoscopic Retrograde Cholangiopancreatography for Primary Biliary Decompression in Distal Malignant Biliary Obstruction (NCT04898777); RCT; Egypt; estimated enrolment n=50; study start date July 2021; estimated study completion date January 2023
Feasibility of EUS-guided Biliary Drainage With LAMS for the Treatment of Patients With Distal Malignant Biliary Obstruction (SPAXUS) (NCT04723199); observational cohort study; Italy; estimated enrolment n=20; study start date December 2020; estimated study completion date December 2021 (results yet to be published)
Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study (NCT04403893); observational cohort study; Italy; estimated enrolment n=20; study start date June 2020; estimated study completion date December 2021 (results yet to be published)
Prospective Multi-site Study of Ultrasound-guided Percutaneous Biliary Drainage and Endoscopic Ultrasound-guided Biliary Drainage With Implantation of a Self-expanding Metal Stent in Patients With Malignant, Distal Bile Duct Obstruction (NCT03546049); RCT; Germany; estimated enrolment n=216; study start date December 2018; estimated study completion date December 2022
Efficacy and Safety of Lumen Apposing Metal Stents: a Retrospective Multicentre Study (NCT03903523); observational cohort study; Italy; estimated enrolment n=500; study start date April 2019; estimated study completion date December 2023
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