Introduction: Obstructive jaundice is a clinical syndrome that is commonly seen in gastroenterology. Endoscopic retrograde cholangiopancreatography (ERCP) has been recognized as a first-choice therapeutic approach, with percutaneous biliary interventions (PBIs) being a viable alternative. Recent data questions the performance and safety profile of PBIs.

Aim: The aim of the present study was to assess retrospectively the short-term clinical outcomes of PBIs in terms of technical and clinical success and adverse events (AEs) rate.

Patients and methods: This is a retrospective, single-center cohort study of 62 consecutive patients subjected to PBI between January 2019 and August 2022.

Results: Technical and clinical success rates of 97.10% and 79.40%, respectively were established. No PBI showed statistically significant superiority over the others. None of the evaluated factors showed significant influence on the therapeutic outcome and AEs. A total AE rate of 26.5% was calculated. All AEs were moderate to severe (grade III-IV according the Clavien-Dindo system). The mean hospital stay was 7.11±3.68 days. A total of 44.1% of the patients required multiple admissions.

Existing studies establish similarly high technical (75%-100%) and acceptable clinical (84%) success rates. Alarmingly high AEs incidence of almost 50% has been found in recently published studies. Infection was the most common adverse event we found in our study. Almost universally, PBIs are used as salvage techniques in patients with malignant disease, failed prior ERCP, and poor performance status.

Conclusion: PBIs remain a viable option to ERCP, but stricter patient selection and a gradual transition to EUS-guided draining procedures are likely required.

biliary drainage, cholangiopancreatography, endoscopy, percutaneous, rendezvous, ultrasound

AEs : adverse events

ECOG : Eastern Cooperative Oncology Group

ERCP : endoscopic retrograde cholangiopancreatography

EUS : endoscopic ultrasonography

EUS-BD : endoscopic ultrasound-guided biliary drainage

EUS-CDS : endoscopic ultrasound-guided choledochoduodenostomy

GB : gall bladder

GI : gastrointestinal

GSD : gallstone disease

ICU : intensive care unit

INR : international normalized ratio

PABS : percutaneous antegrade biliary stenting

PBIs : percutaneous biliary interventions

PC : percutaneous cholecystostomy

PEBD : percutaneous external biliary drainage

PS : performance status

PTBD : percutaneous transhepatic biliary drainage

PT-Rv : percutaneous rendezvous

SEMS : self-expandable metal stent

US : ultrasound

Obstructive jaundice is one of the most challenging conditions to manage in the field of interventional gastroenterology. A variety of both benign and malignant diseases could serve as an underlying cause for such occurrences. Its social relevance is highlighted by real-life data claiming that about 80,000 new cases (8% of all cases of gallstone disease) of choledocholithiasis are established in the USA annually.‌^[1] Furthermore, pancreatic cancer is the fourth most common cause of cancer-related death in Europe and the third most common in the USA, with its incidence expected to rise by 50% by 2035.^{[2, 3]} In about 70% of pancreatic cancer patients jaundice is the leading symptom, with about 80% of them being unfit for surgery at the time of diagnosis. To add on that, in the USA, there are about 7,000 to 8,000 cases of primary biliary tract tumors every year, most of them radically inoperable.^[4]

The presented data underlines the importance of minimally invasive techniques aiming to restore adequate biliary drainage. Historically, surgical treatment of obstructive jaundice has been associated with a high rate of adverse events (5%–30%) and a somewhat high mortality rate (3%–10%).^{[5, 6]} These worrisome numbers lead to a gradual transition from surgical to endoscopic or percutaneous interventions as a primary treatment modality for biliary obstruction, especially in cases induced by unresectable gastrointestinal (GI) malignancies.

Currently, there are three pivotal techniques to obtain biliary drainage in the setting of obstructive jaundice:

1. Endoscopic retrograde cholangiopancreatography (ERCP).

Since its introduction in 1968 by William McCune^[7], ERCP has become the first-line approach in the management of biliary obstruction. Achieving high success (90%-95%) and low adverse event (5.18-9.8%) rates, while preserving the anatomy and physiology of the GI tract, its value in the management of a broad spectrum of biliary disorders is enormous.^[7–10] Unfortunately, achieving drainage via ERCP is impossible in about 3% to 10% of patients due to a variety of factors such as an inaccessible papilla, failure to cannulate, altered anatomy, and so on.^{[8, 11]}

2. Endoscopic ultrasound-guided biliary drainage (EUS-BD).

EUS-BD is a technique developed recently by Giovannini et al., who performed the first endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) in 2001, followed by hepaticogastrostomy in 2003.^{[12, 13]} This technique is predominantly used in patients with malignant diseases, although certain benign indications have emerged in recent years as well.^[14] EUS-BD, albeit alternating the anatomy of the upper GI tract to a certain extent, still preserves the normal flow of bile in the GI lumen. Additionally, it has certain theoretical advantages over ERCP in terms of lower stent occlusion rate. While being acceptably safe (AEs – 29%)^{[15, 16]} and with a high success rate (>90%)^[15], it is worth noting that this subset of procedures is rarely performed outside tertiary expert centers, and their general applicability in every-day clinical practice is still limited.

3. Percutaneous biliary interventions (PBIs).

PBIs is a general term that encompasses a number of interventions unified by access to the biliary tree through a percutaneous route. All of them can be performed under fluoroscopic or sonographic guidance, depending on local expertise. PBIs show high technical and clinical success rates for alleviating hyperbilirubinemia, varying between 90%–100% and 77%–98%, respectively, depending on etiology.^[17] Unfortunately, the complication rate is considerably high (8%-30%), with a mortality rate of 0-3%.^[17] Reinterventions are also an issue with such procedures and are needed in approximately 5%–25% of patients.^{[17, 18]} Other factors that are worth considering (at least for the external drainage procedures) include the persistent need for external drainage catheters, which worsen patients’ quality of life, impair normal intestinal absorption and integrity, and lead to loss of fluid and electrolytes. The spectrum of PBI includes: 1. percutaneous external biliary drainage (PEBD); 2. percutaneous transhepatic rendezvous technique (PT-Rv); 3. percutaneous antegrade biliary stenting (PABS); 4. combined percutaneous and endoscopic techniques (hybrid techniques); and 5. percutaneous cholecystotomy (PC).

With the advent of new EUS-guided drainage techniques, the application of PBIs to ensure biliary drainage is increasingly debated. The clinical outcomes and adverse event rate are under discussion. Little is known about the individual performance of the different types of PBIs. The influence of certain factors such as etiology and level of obstruction, patient’s performance status (PS), and access route on the outcomes has hardly been investigated. Information on the number of interventions needed to achieve and maintain drainage, hospital admissions, and the total duration of hospital stay, which might be considered important surrogates of procedure efficiency, is lacking.

The primary endpoint of the current paper was to evaluate the short-term outcomes of PBIs in terms of technical and clinical success rates and AEs in general and specifically for each type of percutaneous intervention. As a secondary endpoint, we aimed to evaluate the influence of certain factors including type of procedure, utilized access route, etiology, level of obstruction, and patient’s performance status on the outcomes.

Prior to the procedures, oral and written informed consent was obtained, and the patients and their relatives were thoroughly informed about the possible clinical outcomes, adverse events, and complications, as well as the valid alternatives. The study was conducted in accordance with the Declaration of Helsinki and approved by the Local Ethics Committee for studies involving humans.

The study included 68 patients treated with PBIs for various biliary tract disorders at the University Hospital’s Gastroenterology Department between January 2019 and August 2022. The research is designed as a single-center, retrospective cohort study. A total of 92 procedures were analyzed.

Patient selection

Inclusion criteria: age ≥18 years; interventional treatment with any type of PBI (PEBD, PT-Rv, PABS, hybrid techniques, PC) was considered the chief inclusion criterion; follow-up of at least 30 days post-procedure or until death; and competence to give informed consent was also required.

Exclusion criteria: patients lost to the follow-up were excluded from analysis; also, refusal to participate in the study was considered an exclusion criterion.

The patient selection process is shown in Fig. 1.

Figure 1.

Patient selection process.

Hybrid techniques

They encompass a spectrum of procedures usually performed in the setting of complex (hilar) strictures in which a combination of percutaneous and endoscopic approach is utilized. Most commonly a combination of ERCP + PEBD (in accordance with the described technique) was used. A variation is the combination of ERCP + PABS. In this technique, initially an access to one of the liver lobes was ensured in the traditional manner through ERCP. Subsequently, percutaneous puncture of the contralateral ductal system was done and an ERCP guidewire advanced across the stricture and transpapillary (see PABS). Finally, two UC-SEMS were introduced and simultaneously released to achieve bilateral drainage. This technique was valued when bilateral cannulation was impossible endoscopically or when the common bile/hepatic duct was too narrow to introduce two SEMS consecutively.

The steps of combined percutaneous and endoscopic stenting are presented in Figs 2–4.

Figure 2.

A. Previously placed plastic stent and percutaneous catheter for type II proximal biliary obstruction. B. Trans-drainage cholangiography.

Figure 3.

A, B. PT-Rv to obtain access to the left ductal system.

Figure 4.

A. Trans-papillary cannulation of the right ductal system. B. Simultaneous advancement (endoscopic and percutaneous) of two FC-SEMS (8/100 mm).

Obstructive jaundice is a clinical syndrome increasingly established in gastroenterological practice. Its incidence in the general population is estimated to be around 5-7 per 1000 people.^[19] Therapeutic approaches in those patients are constantly evolving, which raises a continuous debate on the optimal management strategy. Treatment decision derives primarily from the etiology of obstruction. Benign causes, the most common of which is choledocholithiasis (54.1% of all cases of obstructive jaundice), are mostly managed non-surgically (endoscopically or percutaneously).^[19] Malignant diseases, if radically operable, are amenable to surgical treatment. In unresectable cases, the emphasis is set on non-surgical methods. Evidently, the mini-invasive treatment is a hallmark of the management of obstructive jaundice. Traditionally ERCP was regarded as the “gold” standard, especially in low biliary obstruction, while percutaneous drainage was a valid alternative and sometimes preferable in the setting of proximal occlusion. The advent of EUS-guided drainage techniques, however, raised a debate on the optimal alternative to ERCP, more recently even being discussed as a first-choice therapy in selected patients.^[20] Additionally, emerging data criticizes the safety profile of PBIs, questioning the benefit-to-risk ratio of the technique.^[21]

The current research included 68 patients, of whom the men were significantly more than the women (72.10% vs. 27.9%). Those results seem contradictory to general data suggesting that obstructive jaundice is more prevalent in women (male:female ratio, 1.0:1.4).^[22] This data, however, largely derives from the considerably higher incidence of GSD in women. PBI in our study (and in general) was rarely performed for choledocholithiasis. If only malignant indications are analyzed, our results are consistent with general knowledge suggesting that men with biliary obstruction are approximately twice as many as women.^[23] In terms of age, we established a mean age of 68.5±11.1 years for the entire group. Again, if only patients with malignant etiology are considered, comparable results are established in other studies (age interval 61-82 years).^[24]

As anticipated malignant obstruction was the primary indication for intervention, comprising 80.8% of all cases, 19.2% of the procedures were performed for benign indications, particularly choledocholithiasis and bile leakage. Similar results were obtained by other researchers.^[21]

We considered the decision-making process to be particularly interesting for the subsequent analysis. Our data shows that PTBD was regarded as a first-choice modality in less than half of the patients (45.60%). More commonly, it was used as a ‘salvage’ technique. In other studies, PTBD was almost entirely an alternative to ERCP.^[25] This data suggests that PBI are largely utilized in “difficult” patients, who would naturally be more prone to adverse events.

The primary endpoint of our study was to establish the short-term clinical outcomes of PBI in terms of technical and clinical success and adverse events rate. A technical success rate of 97.1% for the entire group was established. Technical failure occurred in only two patients in the ED subgroup. This is understandable considering the fact that ED comprises the largest subgroup (52% of all cases). Clinical success was 79.40%, notably higher (but not statistically significant) for the methods associated with internalization of drainage (PABS, PT-Rv). Our results confirm the general finding that, technically, PBI are highly successful. (75%-100%).^[26] Clinical success is also satisfactory, 82.4% on the average and 79.40% in our study.^[26] Existing data on the best percutaneous drainage technique is somewhat inconsistent, but our research suggests that different techniques (at least in the presence of adequate expertise) have similar performance. Our research failed to establish good predictor of therapeutic success (etiology, intervention technique, access route, performance status, etc.). The need for subsequent interventions was consistently (and significantly) associated with decreased clinical response. We might conclude that patients with one or two clinically unsuccessful procedures might benefit from reassessment, preferably in the setting of multidisciplinary team.

In terms of adverse events, we established such in approximately ¼ of all patients (26.5%), the most common complication being cholangitis. More than one complication was established in 7.40% of all cases (38.5% of all adverse events). Notably, all complications were defined as moderate or severe (grade III-V according to the Clavien-Dindo system). No correlation between the adverse event rate and type of procedure was found. The performance status or utilized access route also showed no association with the complication rate. Other studies also failed to establish such a correlation.^[21] It should be stated that the PS in our study was almost universally poor, with more than half of the patients having PS of 3 or 4. Fatal outcome directly associated with the procedure was seen in 3 patients (4.40%). They were all with advanced malignant disease, complex proximal stenosis, and poor PS.

Considerable dispersity exists in the relevant literature on the AEs rate. Even the most optimistic results, however, show a complication rate of around 13%, which might be considered acceptable for patients with malignant disease and is largely comparable to the AE rate of ERCP.^[27] A more recent Dutch study presents quite concerning results, establishing a complication rate of 50% and a mortality directly attributed to the procedure of 8.8%.^[21] This study confirms our observation that infection is the most commonly seen complication. Notably, in the aforementioned study, percutaneous drainage was used as a rescue technique after failed ERCP and in subjects with poor PS. Those facts might at least partially explain the high prevalence of the unfavorable outcomes. Unfortunately, similar outcomes are found in other papers on the subject.^{[28, 29]} In 2016, well-designed Dutch RCT comparing the efficacy and safety of pre-operative drainage by ERCP versus PBI in perihilar cholangiocarcinoma was terminated prematurely because of increased overall mortality rates in the PBI group (3/27 (11%) vs. 11/27 (41%), respectively).^[29] Cholangitis occurred in 59% in the PBI-group vs. 37% in the ERCP-group.^[29]

Upon literature review, we established a tendency (at least in the articles published in the last decade) which is in line with our findings. A complication rate of approximately 30% is found in most papers on the subject. We are inclined to explain this worsening of the clinical outcomes (at least in our study, but we think that this conclusion might be generalized) with the gradual restriction of the indications for PTBD. With the increasing success rate of ERCP even for proximal strictures and the introduction of EUS-BD, PBIs are reserved for patients with advanced disease, poor PS, and limited life expectancy. Negative effects on patient’s life quality is also a major concern.

Considering the life quality in the current study, we evaluated the number of hospital admissions and the mean hospital stay for the patients with PBI. We found that the need for multiple readmissions and continuous hospital in-stay has a profound negative impact on the patients’ life quality, especially in those with advanced malignant disease. We found that half of the patients needed more than one hospitalization (range 2-5) and the mean hospital stay was 7.11±3.68 days (ranging between 3-20 days). About ¼ of all patients needed multiple interventions to achieve and/or sustain therapeutic effect. This data reflects the general opinion that PBIs (even when clinically successful) are impairing patients’ life quality.

The current study has certain limitations. Although it includes consecutive patients, its retrospective nature obviously increases the risk of bias. The lack of control group (ERCP and/or EUS-BD) precludes ensuring of comparability of results. The discrepancy between the studied groups in terms of number of patients should be noted as well. On the other hand, it is our opinion that using hospital data as main source of information makes the results attributable to and quite adequately reflecting real clinical practice.

Management strategies for obstructive jaundice are constantly evolving. PBIs are still a valid option for resolution of biliary obstruction (particularly malignant one), showing acceptable technical and clinical success. Complication rate and life quality impact of PBIs are a major concern, which probably warrants more strict patient selection. ERCP and EUS-BD would likely result in better clinical outcomes. Well-designed prospective comparative studies evaluating ERCP, EUS-BD and PBI for relief of malignant biliary obstruction are needed to verify such statement.

Conceptualization: I.T. and Y.T.; methodology: I.T.; investigation: I.T.; resources: D.T. and I.T.; data curation: D.T.; writing – original draft preparation: I.T.; writing – review and editing: Y.T.; visualization: D.T.; supervision: Y.T.; project administration: Y.T.; funding acquisition: I.T.

This research received no external funding.

Informed consent was obtained from the subject involved in the study.

Data are available on request due to privacy restrictions.

The authors declare no conflict of interest.