EUS-guided Choledochoduodenostomy Research Articles

Efficacy and Safety of EUS-Guided Choledochoduodenostomy Using Electrocautery-Enhanced Lumen-Apposing Metal Stents (ECE-LAMS) in the Treatment of Biliary Obstruction: A Systematic Review and Meta-Analysis

Background. Electrocautery-enhanced lumen-apposing metal stents (ECE-LAMS) have been newly developed to perform EUS-guided choledochoduodenostomy (EUS-CDS), but its benefits and harms remain obscure. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of EUS-CDS using ECE-LAMS. Method. In the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), we searched PubMed, Embase, and Scopus databases through January 1, 2001, and April 27, 2020. The primary outcomes of the pooled analysis were to determine the technical success, clinical success, and overall adverse events rates. The secondary outcomes were pooled rates of short-term and long-term adverse events. Results. Six studies with 270 patients were finally included in this meta-analysis. The pooled rates of technical, clinical success, and adverse events were 95.1% (95% CI = 90.6–97.5%, I2 = 25%), 93.3% (95% CI = 87.4–96.5%, I2 = 28%), and 15.3% (95% CI = 10.6–21.6%, I2 = 13%), respectively. The pooled rates of short-term and long-term adverse events were 3.6% (95% CI = 1.3–9.6%, I2 = 0%) and 11.3% (95% CI = 7.6–16.5%, I2 = 0%), respectively. Conclusion. EUS-CDS using ECE-LAMS provides favorable outcomes in patients with biliary obstruction. It has been associated with a higher success rate and a lower rate of adverse events when compared with the biliary drainage approaches previously used. Large and randomized controlled observational studies are required to further refine the findings in the present analysis.

Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial.

Introduction:In patients with malignant distal bile duct obstruction and normal gastrointestinal anatomy, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is indicated when endoscopic retrograde cholangiopancreatography (ERCP) fails. The ERCP drainage route passes through the tumor, whereas the EUS-CDS route does not. Therefore, EUS-CDS is expected to have a longer stent patency than ERCP. However, for first-line biliary drainage, it remains unclear whether EUS-CDS or ERCP is superior in terms of stent patency. To reduce the frequency of highly adverse events (AEs) such as bile peritonitis or stent migration following EUS-CDS, we developed an antimigration metal stent with a thin delivery system for tract dilatation. This study is designed to assess whether EUS-CDS with this novel stent is superior to ERCP with a traditional metal stent in terms of stent patency when the two techniques are used for first-line drainage of malignant distal biliary obstruction.Methods/design:This study is a multicenter single-blinded randomized controlled trial (RCT) involving 95 patients in four tertiary centers. Patients with malignant distal biliary obstruction that is unresectable or presents a very high surgical risk and who pass the inclusion and exclusion criteria will be randomized to EUS-CDS or ERCP in a 1:1 proportion. The primary endpoint is the stent patency rate 180 days after stent insertion. Secondary outcomes include the rates of technical success, clinical success, technical success in cases not requiring fistulous-tract dilation (only EUS-CDS group), procedure-related AEs, re-intervention success, patients receiving post-drainage chemotherapy, procedure time, and overall survival time.Discussion:If EUS-CDS is superior to ERCP in terms of stent patency and safety for the first-line drainage of malignant distal biliary obstruction, it is expected that the first-line drainage method will be changed from ERCP to EUS-CDS, and that interruption of chemotherapy due to stent dysfunction can be avoided.Trial registration:University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), ID: UMIN000041343. Registered on August 6, 2020. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047201Version number: 1.2, December 7, 2020.

Is a coaxial plastic stent within a lumen-apposing metal stent useful for the management of distal malignant biliary obstruction?

There are uncertainties concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS). The aim of this study was to determine whether a DPS within a biliary LAMS offers a potential benefit in EUS-guided CDS for the palliative management of malignant biliary obstruction. This was a multicentre retrospective study at three tertiary institutions. May 2015 to August 2020. Two interventional strategies (LAMS alone and LAMS plus DPS) were compared. The choice was the endoscopist's discretion. Inclusion: unresectable/inoperable biliopancreatic tumours with previous failed ERCP. Clinical success: bilirubin decrease > 30% at 4weeks. Forty-one consecutive cases of EUS-CDS using biliary LAMS were treated (22 women; mean age, 72.3years) during the study period. The procedure was technically successful in 39 (95.1%), who were managed using the two strategies (22 LAMS alone; 17 LAMS plus DPS). No differences between the groups, in terms of clinical success (77.3 vs 87.5%, p = 0.67), adverse events (AEs, 13.6 vs 11.8%, p = 0.99), recurrent biliary obstruction (RBO, 13.6 vs 23.5%, p = 0.67), or survival rate (p = 0.67) were encountered. The LAMS alone group had a shorter length of procedure (50min vs 66min, p = 0.102). No risk factors related to clinical success, AEs, RBO, or survival were detected. The technical variant of adding a coaxial DPS within LAMS in EUS-CDS seems not to be enough to prevent biliary morbidities, and it is a time-consuming strategy. Although prospective studies are needed, these results do not support its routine use.

EUS-guided choledochoduodenostomy creation using a biliary fully covered self-expanding metal stent after maldeployment of lumen-apposing metal stent.

Video 1Video depicts EUS-guided choledochoduodenostomy creation using a biliary fully covered self-expanding metal stent after maldeployment of a lumen-apposing metal stent.

Efficacy of lumen-apposing metal stents or self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy: a systematic review and meta-analysis.

Endoscopic ultrasound (EUS)-guided biliary drainage is becoming an option for palliation of malignant biliary obstruction. Lumen-apposing metal stents (LAMS) are replacing self-expandable metal stents (SEMS). The aim of this meta-analysis was to evaluate the efficacy and safety of LAMS and SEMS for EUS-guided choledochoduodenostomy (EUS-CDS). A meta-analysis was performed using PRISMA protocols. Electronic databases were searched for studies on EUS-CDS. The primary outcome was clinical success. Secondary outcomes were technical success, reintervention, and adverse events. We used the random effects model with the DerSimonian-Laird estimation, and the results were depicted using forest plots. Subgroup analyses were also performed with data stratified by selected variable. Overall, 31 studies (820 patients) were included. The pooled rates of clinical and technical success were 93.6 % (95 % confidence interval [CI] 88.6 %-96.5 %) and 94.8 % (95 %CI 90.2 %-97.3 %) for LAMS, and 91.7 % (95 %CI 88.1 %-94.2 %) and 92.7 % (95 %CI 89.9 %-94.9 %) for SEMS, respectively. The pooled rates of adverse events were 17.1 % (95 %CI 12.5 %-22.8 %) for LAMS and 18.3 % (95 %CI 14.3 %-23.0 %) for SEMS. The pooled rates of reintervention were 10.9 % (95 %CI 7.7 %-15.3 %) for LAMS and 13.9 % (95 %CI 9.6 %-19.7 %) for SEMS. Subgroup analyses confirmed these results. This meta-analysis showed that LAMS and SEMS are comparable in terms of efficacy for EUS-CDS. Clinical and technical success, post-procedure adverse events, and reintervention rates were similar between LAMS and SEMS use; however, adverse events require further investigation.

Endoscopic ultrasound-guided choledochoduodenostomy in a case of iatrogenic liver injury related bile leak

Endoscopic ultrasound-guided choledochoduodenostomy in a case of iatrogenic liver injury related bile leak

EUS-guided choledochoduodenostomy as a rescue after failed ERCP and percutaneous transhepatic biliary drainage in the management of postoperative benign biliary stricture.

A 34-year-old woman presented with a 4-month history of obstructive jaundice. She had undergone complicated cholecystectomy and common bile duct exploration 5 years earlier. She underwent surgical choledochoduodenostomy (CDS) for recurrent biliary obstruction 5 months after the first surgery. She was asymptomatic until 4 months earlier, when she presented with obstructive jaundice and cholangitis. Magnetic resonance cholangiopancreatography showed a smooth common hepatic duct stricture, intrahepatic stones and bilateral intrahepatic biliary radicle (IHBR) dilatation.

Lumen apposing metal stents versus tubular self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy in malignant biliary obstruction.

EUS-guided choledochoduodenostomy (EUS-CDS) is an effective option for biliary drainage in malignant biliary obstruction. Lumen apposing metal stents (LAMS) are increasingly been used for EUS-CDS. It is unknown how LAMS compare to tubular self-expandable metal stents (SEMS) for EUS-CDS. Our aim is to compare the clinical outcomes of LAMS versus SEMS for EUS-CDS. Single-center retrospective cohort study of consecutive patients with unresectable malignant biliary obstruction who underwent EUS-CDS after failed ERCP for initial biliary drainage between 2011 and 2019. Clinical outcomes were compared between patients who had conventional covered SEMS and LAMS placed for EUS-CDS. Outcome measures included unplanned procedural events, technical success, clinical success, adverse events and reinterventions. Survival was analyzed by the Kaplan-Meier method. During the study period 57 patients met inclusion criteria (37 LAMS, 20 SEMS). All EUS-CDS were technically successful (LAMS group 95% CI 90.3-100%, SEMS group 95% CI 83.2-100%). There were no differences between groups in unplanned procedural events (4 LAMS deployment issues, 2 mild bleeding in SEMS group; 10 vs 10.8%), clinical success (37/37 [100%] vs 19/20 [95%]), and short-term adverse events (5/37 [13.5%] vs 4/20 [20%], p = 0.71). Complete follow-up data were available in 41 patients for a mean of 376 ± 145days. Endoscopic reintervention was required for duodenal stent placement (n = 9) or biliary stent dysfunction (n = 4), with no difference between LAMS and SEMS group (6/37 [16.2%] vs 7/20 [35%]). There were no differences in overall survival between both groups. EUS-guided choledochoduodenostomy after failed ERCP has equally high technical and clinical success rates with either LAMS or SEMS in patients with malignant biliary obstruction. No differences in adverse events, reinterventions and survival were seen with either type of stent. The cost-effectiveness of LAMS vs SEMS for EUS-guided choledochoduodenostomy remains to be proven.

Double stenting with EUS-CDS using a new anti-reflux metal stent for combined malignant biliary and duodenal obstruction.

Highlight Sasaki and colleagues report their experience with double stenting combined with endoscopic ultrasound-guided choledochoduodenostomy using a new anti-reflux metal stent to prevent duodenobiliary reflux in combined biliary and duodenal obstruction. This double stenting method is a new strategy for the management of combined biliary and duodenal obstruction.

Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation using a novel fully covered metallic stent with a 5.9-Fr ultra-thin delivery system.

Endoscopic ultrasonography-guided choledochoduodenostomy (EUS-CDS) is a potential procedure for primary drainage in unresectable malignant distal biliary obstruction and can replace endoscopic retrograde cholangiopancreatography. However, adverse events following EUS-CDS are occasionally reported, the most common being bile leak due to fistula dilation [1] [2]. The safety of EUS-CDS without fistula dilation using two types of thin, fully covered self-expandable metallic stents (FCSEMSs) has been previously reported [3] [4] [5]. Here we report a case in which EUS-CDS without fistula dilation was successfully performed using a novel FCSEMS with a 5.9-Fr delivery system (Hanarostent Benefit; M.I.Tech, Seoul, Korea) ([Fig. 1]).

Three Cases of Difficult Bile Duct Stone Removal by EUS-guided Choledochoduodenostomy

After failed removal of common bile duct or intrahepatic bile duct (IHD) stones by endoscopic retrograde cholangiopancreatography (ERCP), percutaneous lithotripsy is well-known as an effective procedure. However, it is time-consuming because multiple sessions of transhepatic tract dilatation are required. Endoscopic ultrasound (EUS)-guided choledochoduodenostomy (CDS) has been recently used to approach IHD to remove difficult bile duct stones. We recently experienced EUS-guided CDS performed with metal stent. Common bile duct or IHD stones were removed by retrieval accessories after initial failed or inadequate ERCP in three patients. Serious complications including bleeding, infection, and perforation were not noted. The duration of hospital stay from EUS-guided procedure to discharge ranged from 10 to 14 days. Although this result is interim and ongoing, it suggests that EUS-guided CDS might be an effective and safe procedure after failed ERCP to remove difficult bile duct stones through the tract.

Comparison Study between Double Bare Covered and Fully Covered Metal Stent during Endoscopic Ultrasound-Guided Choledochoduodenostomy (with Video)

Background: Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is a common technique for biliary drainage. However, EUS-CDS is associated with adverse events such as cystic duct obstruction, stent dislocation, and stent kinking caused by powerful axial force. A novel double-bare, covered self-expandable metal stent (DBSEMS) has recently become available in Japan. This pilot study evaluated the clinical outcomes of EUS-CDS using DBSEMS. Method: We retrospectively enrolled patients with malignant lower bile duct obstruction who underwent EUS-CDS due to failed endoscopic retrograde cholangiopancreatography (ERCP). EUS-CDS procedures performed between April 2017 and March 2018 used a conventional fully covered self-expandable metal stent (FCSEMS), and those performed between April 2018 and April 2019 used DBSEMS. In all stents, the diameter was 10 mm and length was 6 cm. Results: A total of 22 patients underwent EUS-CDS, performed using conventional FCSEMS (n = 12) and DBSEMS (n = 10). Four complications occurred with FCSEMS: cholangitis due to kinking (n = 3) and stent dislocation (n = 1). With DBSEMS, there were no instances of kinking, and reflux cholangitis that developed in 1 patient due to duodenal obstruction was resolved by duodenal stenting. Elapsed time to recurrent biliary obstruction was longer with DBSEMS than FCSEMS (200 vs. 99 days), although the difference was not significant (p = 0.06). Conclusion: BSEMS can help prevent cholangitis due to stent kinking after EUS-CDS, thus increasing stent patency.

Pancreaticoduodenectomy following endoscopic ultrasound-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing stents an ACHBT – SFED study

BackgroundAfter ERCP failure or if ERCP is declined for preoperative biliary drainage before pancreaticoduodenectomy, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with electrocautery-enhanced lumen-apposing stents (ECE-LAMS) might be needed. The aim of the present study was to assess the technical feasibility and short-term outcomes of pancreaticoduodenectomy (PD) following endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with electrocautery-enhanced lumen-apposing stents (ECE-LAMS). MethodsA retrospective study of all EUS-CDS procedures with ECE-LAMS followed by PD performed in France since the availability of the device in 2016. Results21 patients underwent PD in 9 departments of surgery following EUS-CDS with ECE-LAMS. The median bilirubin level at endoscopic procedure was 292 μmol/L. A 6 mm diameter stent was used in 20 cases. No complications occurred during the procedure. During the waiting time, 1 patient had an acute pancreatitis post ERCP and 3 patients developed cholangitis, treated by either an additional percutaneous biliary drainage, or an endoscopic procedure to extract a bezoar occluding the stent, or antibiotics, respectively. PD with a curative intent was performed in all cases. Overall, postoperative mortality was nil and postoperative morbidity occurred in 17 patients (81%), including 3 with severe complications (14%). No patient developed postoperative biliary fistula. In the 21 patients followed at least 6 months, no biliary complications occurred, and no tumor recurrence developed on the hepaticojejunostomy/hepatic pedicle. ConclusionPancreaticoduodenectomy following EUS-CDS with ECE-LAMS is technically feasible with acceptable short-term postoperative outcome, including healing of biliary anastomosis.

Endoscopic management of symptomatic walled-off omental fat necrosis.

Endoscopic management of symptomatic walled-off omental fat necrosis.

Outcomes of EUS-guided choledochoduodenostomy as primary drainage for distal biliary obstruction with covered self-expandable metallic stents.

Background and study aims Endoscopic ultrasonography-guided choledochoduodenostomy (EUS-CDS) is an alternative therapy for percutaneous transhepatic biliary drainage. Outcomes of EUS-CDS for distal biliary tract obstruction with a covered self-expandable metallic stent (SEMS) as a primary drainage technique are unclear because there are few relevant reports. This study aimed to determine outcomes in patients undergoing EUS-CDS using SEMS as the primary drainage technique for malignant distal biliary duct obstruction. Patients and methods This retrospective study was conducted at Aichi Cancer Center Hospital, from January 2010 to July 2018, using data from our database. Results EUS-CDS was performed as a primary drainage technique for 92 patients. The technical success rate was 92.8 %, and the clinical success rate was 91.6 %. The overall incidence of adverse events was 15.7 %. The median stent patency time for the EUS-CDS was 396 days. Nineteen patients required re-intervention because of cholangitis or jaundice. Conclusion EUS-CDS as a primary drainage technique using SEMS has high technical and clinical success rates. It should be considered an effective drainage method with respect to long-term stent patency, low re-intervention rates, and absence of severe complications.

Application and Value of Endoscopic Ultrasonography Guided Biliary Interventional Therapy in Patients With Biliary Obstruction and Surgically Altered Anatomy.

The aim of this study was to evaluate the efficacy and safety of endoscopic ultrasound-guided biliary drainage (EUS-BD) in patients with biliary obstruction and surgically altered anatomy. This was a retrospective study. We collected data from 60 patients with biliary obstruction and surgically altered anatomies who undergone EUS-BD (group A, 33 cases) and percutaneous transhepatic biliary drainage (PTBD) (group B, 27 cases) after unsuccessful endoscopic retrograde cholangiopancreatography from January 2016 to January 2018. The operation success rate, the clinical success rate, complications, hospital stay were observed. In group A, 31 cases of 33 patients were successfully operated and placed stents or drainage tube by endoscopic ultrasound puncture [endoscopic ultrasonography (EUS) guided rendezvous 8, EUS-guided hepaticogastrostomy 14, EUS-guided choledochoduodenostomy 11], 28 had a significant decrease in jaundice. The complications rate was 9.1% (biliary bleeding 2; acute cholangitis 1). There was statistically significant difference in the complications [9.09% (3/33) vs. 33.33% (9/27), χ=5.45, P<0.05] and length of hospital stay (14.45±5.78 vs. 18.52±8.64 d, t=10.03, P<0.01) between group A and group B. There was not statistical significance in the technical and clinical success rate between 2 groups [93.94% (31/33) vs. 92.60% (25/27), 84.85% (28/33) vs. 85.19% (23/27), χ1=0.10, χ2=0.11, P>0.05]. EUS-BD may be the first choice for patients with biliary obstruction and surgically altered anatomy after a failed endoscopic retrograde cholangiography in centers with expertise in EUS-BD procedures.

Risk factor analysis for adverse events and stent dysfunction of endoscopic ultrasound-guided choledochoduodenostomy.

Although the technique of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is becoming standardized, its safety issues have not been sufficiently investigated. Therefore, we aimed to identify factors associated with adverse events and stent patency in EUS-CDS. Consecutive patients who underwent EUS-CDS between September 2003 and July 2017 were included. Technical/clinical success, adverse events and stent dysfunctions were analyzed retrospectively. A total of 151 patients underwent EUS-CDS. In nine patients, procedures were discontinued before puncture. Technical and clinical success rates were 96.5% (137/142) and 98.5% (135/137), respectively. The adverse event rate was 20.4% (29/142). As a risk factor for peritonitis, plastic stents (PS) showed a significantly high odds ratio (OR) compared with covered self-expandable metal stents (CSEMS; OR, 4.31; P = 0.030). CSEMS cases showed a significantly longer patency period than PS cases (329 vs 89 days; HR, 0.35; P < 0.001). As a risk factor for early stent dysfunction (within 14 days), stent direction to the oral side showed a significantly high OR (OR, 43.47; P < 0.001). In cases with oblique-viewing EUS, double penetration of the duodenum occurred at significantly higher frequency than in cases with forward-viewing EUS (7.0 vs 0.0%; P = 0.024). Plastic stents and stent direction to the oral side were risk factors for peritonitis and early stent dysfunction, respectively. Using covered self-expandable metal stents and changing stent direction to the anal side seemed appropriate to prevent peritonitis and early stent dysfunction.

Effectiveness and safety of EUS-guided choledochoduodenostomy using lumen-apposing metal stents (LAMS): a systematic review and meta-analysis.

Endoscopic ultrasound-guided choledochoduodenostomy (CDD) is emerging as an alternative technique for biliary drainage in patients who fail conventional endoscopic retrograde cholangiopancreatography (ERCP). The lumen-apposing metal stents (LAMS) are being increasingly used for CDD. We performed a systematic review and meta-analysis to evaluate the effectiveness and safety of CDD using LAMS. We performed a systematic search of multiple databases through May 2019 to identify studies on CDD using covered self-expanding metal stents. Pooled rates of technical success, clinical success, adverse events, and recurrent jaundice associated with CDD using LAMS were estimated. A subgroup analysis was performed based on use of LAMS with electrocautery-enhanced delivery system (EC-LAMS). Seven studies on CDD using LAMS (with 284 patients) were included in the meta-analysis. Pooled rates of technical and clinical success (per-protocol analysis) were 95.7% (95% CI 93.2-98.1) and 95.9% (95% CI 92.8-98.9), respectively. Pooled rate of post-procedure adverse events was 5.2% (95% CI 2.6-7.9). Pooled rate of recurrent jaundice was 8.7% (95% CI 4.5-12.8). On subgroup analysis of CDD using EC-LAMS (5 studies with 201 patients), the pooled rates of technical and clinical success (per-protocol analysis) were 93.8% (95% CI 90.4-97.1) and 95.9% (95% CI 91.9-99.9), respectively. Pooled rate of post-procedure adverse events was 5.6% (95% CI 1.7-9.5). Pooled rate of recurrent jaundice was 11.3% (95% CI 6.9-15.7). Heterogeneity (I2) was low to moderate in the analyses. CDD using LAMS/EC-LAMS is an effective and safe technique for biliary decompression in patients who failed ERCP. Further studies are needed to assess CDD using LAMS as primary treatment modality for biliary obstruction.

EUS-guided choledochoduodenostomy by use of electrocautery-enhanced lumen-apposing metal stents: a French multicenter study after implementation of the technique (with video)

EUS-guided biliary drainage is indicated in cases of impossibility or failure of classic biliary drainage by ERCP. Recently we reported good efficiency of EUS-guided choledochoduodenostomy (EUS-CDS) using the electrocautery-enhanced lumen-apposing metal stent (ECE-LAMS) in a retrospective multicenter study. Use of the recommended technique (direct puncture with the ECE-LAMS with use of a pure cut current and a 6-mm stent) was the only predictive factor of clinical success. We re-evaluated this procedure after 1 year in the same centers. This was a French retrospective multicenter study of a prospective database including all cases of EUS-guided CDS with ECE-LAMS in the 7 centers that participated in the first study. Seventy consecutive patients were included in this study between September 1, 2017, and September 22, 2018. Failure of primary ERCP was due to duodenal stenosis in 44% of cases and to tumoral infiltration of the papilla in 22% of cases. The mean duration of the procedure was 5 ± 3 minutes. The recommended technique was used in 98.5% of cases. The technical and clinical success rates were both 97.1% (69/70). Short-term adverse events (periprocedural and intrahospital) occurred in 1.6%. EUS-CDS with the ECE-LAMS is efficacious and safe in distal malignant obstruction of the common bile duct in cases of ERCP failure with impressive results once expertise is acquired and the recommended technique (direct fistulotomy, pure cut current, and 6-mm stent) is followed.

Rescue ERCP after delayed migration of a lumen-apposing metal stent following endoscopic ultrasound-guided choledochoduodenostomy.

Rescue ERCP after delayed migration of a lumen-apposing metal stent following endoscopic ultrasound-guided choledochoduodenostomy.