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EUS-guided transhepatic biliary drainage for next-generation ERCPists

Published:January 15, 2022DOI:https://doi.org/10.1016/j.gie.2021.11.016

      Abbreviations:

      AE (adverse event), ETBD (endoscopic transhepatic biliary drainage), EUS-BD (EUS-guided biliary drainage), HGS (hepaticogastrostomy), PTBD (percutaneous transhepatic biliary drainage)
      ERCP is the standard treatment of choice for benign and malignant biliary obstructions. However, it is not always successful and often can be challenging in patients with surgically altered anatomy or duodenal obstruction. For several years, percutaneous transhepatic biliary drainage (PTBD) has been the standard of care in these situations. Recently, EUS-guided biliary drainage (EUS-BD), including hepaticogastrostomy (HGS) and choledochoduodenostomy, has emerged as an alternative treatment in patients with ERCP failure. Recent meta-analyses demonstrated similar or better outcomes of EUS-BD than PTBD in terms of the rates of technical success, clinical success, adverse events (AEs), or re-interventions.
      • Sharaiha R.Z.
      • Khan M.A.
      • Kamal F.
      • et al.
      Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis.
      However, the use of EUS-BD varies widely among countries, and several hurdles still exist in its popularization.
      • Yoon W.J.
      • Park D.H.
      • Choi J.H.
      • et al.
      The underutilization of EUS-guided biliary drainage: perception of endoscopists in the East and West.
      In the current issue of Gastrointestinal Endoscopy, Hathorn et al
      • Hathorn K.E.
      • Canakis A.
      • Baron T.H.
      EUS-guided transhepatic biliary drainage: a large single-center U.S. experience.
      report a large-scale single-center retrospective study of EUS-guided transhepatic biliary drainage (ETBD) in patients with benign and malignant biliary diseases. The term ETBD was used as a counterpart of PTBD, and the procedure was performed from various access points, including the esophagus, stomach, duodenum, and jejunum, although HGS was performed in ∼90% of the cases. This ETBD was performed by a single expert endoscopist between September 2014 and May 2021. Fully covered, nonforeshortening, self-expandable metal stents were used with an anchoring plastic stent in almost all cases. In this retrospective study, ETBD was attempted in 215 patients (85 with benign lesions and 130 with malignant lesions). Overall, 71.8% patients in the benign disease cohort and 23.8% in the malignant disease cohort had surgically altered anatomy. Ninety-four patients (43.7%) had a previous history of failed ERCP. The technical and clinical success rates were 95.3% and 87.25%, respectively. AEs occurred in 40 (18.6%) patients. The reintervention rate was 17.4% for patients with malignant disease who survived for >6 months. The authors preferred to perform ETBD rather than EUS-guided choledochoduodenostomy when the duodenal bulb was intact, owing to the difficulty in the management of retroperitoneal stent misdeployment, risk of bleeding, or potential for difficult surgical resection in patients with distal malignant biliary obstruction. However, further larger comparative studies may be required for resolving these controversial issues.
      The authors should be commended for a thorough review of ETBD outcomes in a large series of patients with benign and malignant disease. The short-term outcomes and AE rates were comparable with those reported by previous studies conducted in Asian and European countries. Inasmuch as ETBD is not been widely performed in the United States, compared with other countries, for several reasons, such as the limited availability of dedicated accessories or reimbursement issues, these results are quite remarkable.
      • Barakat M.T.
      • Adler D.G.
      EUS-guided biliary drainage: a realistic perspective.
      Overall, 40 patients (18.6%) experienced AEs: 19 (16.2%) and 21 (21.4%) patients from the benign and malignant cohorts, respectively. These events included 13 mild, 21 moderate, and 6 severe AEs according to the modified lexicon criteria of the American Society for Gastrointestinal Endoscopy. Moreover, a majority of the cases were infection related. Serious AEs included septic shock (n = 4), hemodynamic instability related to postprocedural bleeding (n = 1), and perforation requiring exploratory laparotomy (n = 1). No patient experienced bile peritonitis secondary to leakages or intraperitoneal stent migration, which have been the most concerning AEs reported previously.
      • Forbes N.
      • Coelho-Prabhu N.
      • Al-Haddad M.A.
      • et al.
      ASGE Standards of Practice Committee
      Adverse events associated with EUS and EUS-guided procedures.
      In this study, the outpatient cases constituted 40% of the cohort, and approximately 14% of them were admitted after the procedure. Considering these AE profiles, the ETBD procedure in an outpatient setting may be presumed to be risky and uncomfortable until its standardization with a dedicated device.
      The AE rates were higher at the beginning of the studies and tended to decrease over time, indicating that a learning curve exists in the performance of ETBD. Previous studies suggested that 33 cases were required for learning EUS-guided HGS, based on the procedure time and AEs.
      • Oh D.
      • Park D.H.
      • Song T.J.
      • et al.
      Optimal biliary access point and learning curve for endoscopic ultrasound-guided hepaticogastrostomy with transmural stenting.
      Tyberg et al
      • Tyberg A.
      • Mishra A.
      • Cheung M.
      • et al.
      Learning curve for EUS-guided biliary drainage: what have we learned?.
      reported that the mastery of EUS-BD is achieved after ∼100 cases. However, the necessity of EUS-BD is not considerably high, even in a tertiary care center. In a previous study, EUS-BD was required in only 0.6% (3/524) of native papillae; however, this study had few patients with surgically altered anatomy (n = 2) and duodenal obstruction (n = 3).
      • Holt B.A.
      • Hawes R.
      • Hasan M.
      • et al.
      Biliary drainage: role of EUS guidance.
      Therefore, the learning curve of EUS-guided HGS or BD may be a challenging issue in small-ERCP-volume centers.
      As the authors have acknowledged, this study has several notable limitations. First, the results may not be generalizable because the procedure was performed by a single experienced endoscopist in a tertiary center. Even in the hands of an expert with extensive experience of ERCP and therapeutic endosonography, the AE rate was as high as 19.5%, including 2.8% cases of severe AEs. Second, this study had no comparative group. Because the study population was composed of patients with heterogeneous causes of biliary obstruction, it is difficult to design a study that can directly compare the outcomes of ETBD and PTBD.
      Given the low rate of ERCP failure, most next-generation performers of ERCP might have limited experience of ETBD. Subsequently, the following question arises: How can we develop ETBD as a comfortable procedure? First, significant ERCP experience might be a prerequisite for the steep learning curve of ETBD. Performing EUS-BD without adequate experience of ERCP may be dangerous and harmful for patients, similar to the case of a surgeon performing robotic or laparoscopic surgery without the experience of open surgery. Second, ETBD can be considered in selected patients with highly expected failed ERCP, such as those with surgically altered anatomy. Thus, patients who are deemed suitable to undergo ETBD could be provided with the opportunity to give informed consent before the start of ERCP. Although this process may be time-consuming, a larger number of patients who would be benefit from ETBD could immediately undergo the procedure after failed ERCP in the same session, without interruption of the endoscopic procedure. Third, with the impact of systemic chemotherapy, the demand by patients with a long-term PTBD tube for internalization may be increasing. The conversion of external PTBD to ETBD may be useful for beginners in ETBD with substantial experience of ERCP; this is because temporary PTBD tube clamping and injection of contrast material through the PTBD tube for artificial intraductal dilation may enhance bile duct access during ETBD. Although the ETBD procedure would be failed in a patient with a longstanding PTBD tube, it would be better to attempt ETBD in such a patient with an uncomfortable external drainage tube.
      • Paik W.H.
      • Lee N.K.
      • Nakai Y.
      • et al.
      Conversion of external percutaneous transhepatic biliary drainage to endoscopic ultrasound-guided hepaticogastrostomy after failed standard internal stenting for malignant biliary obstruction.
      Fourth, hands-on training or use of a simulator for ETBD may be helpful for surgeons to gain experience and perform this procedure comfortably. Fifth, on the basis of this study and our experience,
      • Oh D.
      • Park D.H.
      • Song T.J.
      • et al.
      Optimal biliary access point and learning curve for endoscopic ultrasound-guided hepaticogastrostomy with transmural stenting.
      dilation of the intrahepatic duct to at least 5 mm in diameter may be required for easy access with ETBD. Therefore, the ERCP physician can choose suitable patients with good indications for ETBD, and this might be the number one priority for a successful and comfortable procedure.
      This large-scale retrospective study conducted in a single tertiary center in the United States shows that ETBD has high technical and clinical success with modest AE rates in patients with benign and malignant biliary obstruction. With time, the volume of the procedure has increased rapidly, and the AE rates have decreased steadily. This study shows that ETBD has the potential to be an important tool in the repertoire of next-generation ERCP physicians. However, we recommend caution in the interpretation of the current data because the ETBDs in this retrospective study were performed by a single high-level expert. Further studies are necessary to elucidate the long-term outcomes of ETBD and the learning curve, and to identify training-related issues. However, given that the number of patients with biliary obstruction and surgically altered anatomy—or those with favorable oncologic outcomes and prolonged life expectancy who would require ETBD as an alternative to PTBD—is increasing, and because a dedicated device for ETBD has been introduced, the era of ETBD is expected to arrive in the immediate future.

      Disclosure

      Both authors disclosed no financial relationships.

      References

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      Linked Article

      • EUS-guided transhepatic biliary drainage: a large single-center U.S. experience
        Gastrointestinal EndoscopyVol. 95Issue 3
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          EUS-guided hepaticogastrostomy has been performed for many years with most published experience from outside the United States. The luminal access point can be from the esophagus, stomach, duodenum, or jejunum; biliary access can be either into the right or left intrahepatic system. Thus, we prefer the term EUS-guided transhepatic biliary drainage (ETBD). We describe what is believed to be the largest single-center U.S. experience of ETBD for management of benign and malignant biliary disease.
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