Safety and Efficacy of Covered Self-Expandable Metallic Stent for Choledochojejunal Anastomotic Stricture: A Multi-Center Retrospective Cohort Study.

BACKGROUND: Benign choledochojejunal anastomotic stricture (CJS) is a complication of pancreaticoduodenectomy and choledochojejunostomy. Typically managed with endoscopic balloon dilatation, CJS has a high recurrence rate. Covered metallic stent (CMS) placement is a potential alternative; however, a comprehensive evaluation is lacking. OBJECTIVES: The aim of this study was to evaluate the treatment outcomes of CMS placement in patients with CJS. METHODS: We retrospectively analyzed patients who underwent balloon dilation via endoscopic retrograde cholangiopancreatography using a double-balloon endoscope for CJS between October 2010 and October 2023. The study outcomes included technical and clinical success rates, adverse event rates, choledochojejunal anastomotic stricture recurrence rates, and time to recurrence for balloon dilation and CMS treatment for CJS. RESULTS: There were 43 patients, 55 procedures (40 balloon dilation and 15 CMS placement). The technical and clinical success rates were 100% for both treatments. Recurrence of CJS was observed in 35% (14/40) of the patients in the balloon dilation group. The recurrence rate was significantly higher in the balloon dilation group than in the CMS group (35% vs. 0%, p = 0.006). The time to CJS recurrence was significantly shorter in the balloon dilation group than in the covered metallic stent group (NR vs. NR, p = 0.03). CONCLUSION: Placement of CMS for treating patients with CJS was demonstrated to be an effective and safe method with a lower recurrence rate than balloon dilation.

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.

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

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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.

Initial clinical experience of a steerable access device for EUS-guided biliary drainage.

BACKGROUND AND AIMS: EUS-guided biliary drainage (EUS-BD) has been used as a rescue procedure after failed endoscopic retrograde cholangiography (ERC), and there is growing interest in EUS-BD as a primary therapy for distal malignant biliary obstruction. After EUS-guided needle puncture of an obstructed bile duct, directional control of wire advancement remains an area of need, potentially addressed by a new steerable EUS access system. The aim of this study was to evaluate the safety and efficacy of this novel steerable access system in patients undergoing EUS-BD after failed ERC. METHODS: We performed a retrospective study of prospectively acquired data at 3 tertiary academic hospitals. Consecutive patients who had failed ERC followed by EUS-BD using the access device were included. Primary outcomes were safety and technical feasibility (successful completion of EUS-BD). Secondary outcomes were clinical success (75% improvement in liver function tests at 30 days) and device performance. RESULTS: Twenty-two consecutive patients underwent EUS-BD between October 10, 2018 and March 3, 2019. Needle puncture and selective wire advancement in the intended direction were both successful in 100% of cases (22/22). Technical success was 95% (21/22). Fifty-nine percent (13) underwent rendezvous, 32% (7) underwent choledochoduodenostomy, and 4.5% (1) underwent hepaticogastrostomy. One patient (4.5%) underwent percutaneous transhepatic cholangiography. There were no cases of wire shearing. The adverse event rate was 4.5% (mild pancreatitis in 1 patient). There was no bile leak, bleeding, or death at 30 days' follow-up. CONCLUSIONS: This first clinical experience with a steerable access system for EUS-BD suggests it is safe and effective, particularly with regard to controlling direction of wire advancement.

Magnetic compression anastomosis for the treatment of benign biliary strictures: a clinical study from China.

BACKGROUND: Magnetic compression anastomosis (MCA) is a revolutionary minimally invasive method to perform choledochocholedochostomy in patients with benign biliary stricture (BBS). We conducted MCA for the treatment of severe BBS that could not be treated by conventional methods. PATIENTS AND METHODS: Patients with BBSs that could not be treated using conventional treatments were included. All patients underwent percutaneous transhepatic biliary drainage (PTBD) before MCA, and underwent cholangiography via simultaneous PTBD and endoscopic retrograde cholangiopancreatography (ERCP). The MCA device consisted of a parent and a daughter magnet. The daughter magnet was delivered via the PTBD route to the proximal end of the obstruction, and the parent magnet was delivered via ERCP to the distal end of the obstruction. After recanalization, the MCA device was removed, and biliary stenting (or PTBD) was performed for at least 6 months. RESULTS: Of the 9 patients (age 49 ± 12.9 years), 6 had undergone orthotopic liver transplantation. MCA was successful in all 9 patients. The stricture length was 3 ± 1.7 mm, and recanalization occurred after 16.3 ± 13.2 days. Multiple plastic stents (4 patients), fully covered self-expandable metallic stents (4 patients), or PTBD (1 patient) was used after recanalization. Two mild adverse events occurred (cholangitis, 1 patient; biliary bleeding, 1 patient), but were resolved with conservative treatment. Stents were retrieved after > 6 months, and no stenosis occurred during 2-66 months of stent-free follow-up. CONCLUSION: The MCA technique is a revolutionary method for choledochocholedochostomy in patients with severe BBS unresponsive to conventional procedures.

Comprehensive and innovative techniques for laparoscopic choledocholithotomy: A surgical guide to successfully accomplish this advanced manipulation.

Surgeries for benign diseases of the extrahepatic bile duct (EHBD) are classified as lithotomy (i.e., choledocholithotomy) or diversion (i.e., choledochojejunostomy). Because of technical challenges, laparoscopic approaches for these surgeries have not gained worldwide popularity. The right upper quadrant of the abdomen is advantageous for laparoscopic procedures, and laparoscopic choledochojejunostomy is safe and feasible. Herein, we summarize tips and pitfalls in the actual procedures of choledocholithotomy. Laparoscopic choledocholithotomy with primary closure of the transductal incision and transcystic C-tube drainage has excellent clinical outcomes; however, emergent biliary drainage without endoscopic sphincterotomy and preoperative removal of anesthetic risk factors are required. Elastic suture should never be ligated directly on the cystic duct. Interrupted suture placement is the first choice for hemostasis near the EHBD. To prevent progressive laceration of the EHBD, full-layer interrupted sutures are placed at the upper and lower edges of the transductal incision. Cholangioscopy has only two-way operation; using dedicated forceps to atraumatically grasp the cholangioscope is important for smart maneuvering. The duration of intraoperative stone clearance accounts for most of the operative time. Moreover, dedicated forceps are an important instrument for atraumatic grasping of the cholangioscope. Damage to the cholangioscope requires expensive repair. Laparoscopic approach for choledocholithotomy involves technical difficulties. I hope this document with the visual explanation and literature review will be informative for skillful surgeons.

Beyond palliation: using EUS-guided choledochoduodenostomy with a lumen-apposing metal stent as a bridge to surgery. a case series.

We present five cases of pylorus-preserving pancreaticoduodenectomy (PPPD) after endoscopic ultrasonography-guided choledochoduodenostomy (EUS-CD) using a lumen-apposing metal stent (LAMS) as a bridge to surgery in patients with resectable distal malignant biliary obstruction and failed endoscopic retrograde cholangiopancreatography (ERCP). The patients underwent an EUS-CD using EC-LAMS, the bile duct being accessed using the transbulbar approach. The technical success rate of EUS-CD was 100%. No procedure-related adverse events occurred. All patients underwent PPPD with a technical success rate of 100%. The presence of a transduodenal LAMS did not impede surgery. No biliary or duodenal fistula occurred in the patients. Pancreatic fistulas with late bleeding were observed in two patients (one fatal). These few cases indicate that PPPD after EUS-CD using LAMS is feasible and safe. EUS-CD should be performed irrespective of the stage of the disease, also for patients fit for surgery. Additional larger prospective studies are required to confirm this preliminary data, in particular for possible interference with postoperative outcomes.

Selective Indication of T-Tube in Liver Transplantation: Prospective Validation of the Results of a Randomized Controlled Trial.

BACKGROUND AND AIMS: T-tube placement during choledochocholedochostomy (CCS) associated with liver transplantation (LT) remains controversial. This study was designed to validate the results of an earlier prospective randomized controlled trial (RCT) on use versus nonuse of the T-tube during CCS associated with LT. METHODS: Prospective cohort study. The primary outcome was the overall incidence of biliary complications (BCs). RESULTS: In total, 405 patients were included, and the median overall monitoring period was 29 months (interquartile range: 13-47 months). Selective use of the T-tube reduced BCs (23% vs 13%; P = .003), of which 75% were type IIIa or less in the Clavien-Dindo classification. The overall BC rate did not differ between patients with versus without T-tube placement. CONCLUSIONS: We confirmed that selective use of a rubber T-tube during CCS associated with LT, following the principles established in our prospective RCT, reduced the rate of BC by 10% without detriment, even after enrolling patients at an a priori greater risk of BCs than were the RCT patients.

Endoscopic ultrasound-guided choledochoduodenostomy using a lumen apposing metal stent for acute cholangitis.

We present the case of a 51-year-old woman with a history of uterine cancer who presented to the emergency room with a clinical picture of acute cholangitis. An abdominal ultrasound and a computed tomography scan were performed, revealing a gigantic lymphadenopathy mass compressing the common bile duct and the duodenum. After failure to perform an endoscopic retrograde cholangiopancreatography (ERCP) due to a modified anatomy, we performed an endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) and placed a Hot AXIOS 10Fr/10 mm stent with efficient biliary drainage. In addition, we inserted a duodenal uncoated 120/22 mm expandable metallic stent. EUS-CDS presents a valid alternative in patients with failed ERCP and should be considered as an important option for rapid biliary decompression in patients with acute cholangitis.

Long-term outcomes of EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction: a prospective multicenter study.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDS) using conventional tubular stents has been successfully performed. However, EUS-CDS carries a high risk of bile leakage with attendant adverse events. This study aimed to prospectively evaluate the long-term outcome of EUS-CDS using a dedicated lumen-apposing metal stent (LAMS). METHODS: Nineteen patients (mean age, 70.6 years; 12 men) with unresectable malignant diseases were treated in 5 tertiary referral centers. EUS-CDS was performed using a fully covered LAMS with a cautery-enhanced delivery system for EUS-CDS. RESULTS: All stents were successfully deployed without any adverse events. Jaundice improved in 79% of the patients within 7 days and finally in 95%. In 95% of patients the stents remained in good anastomotic position without migration or dislocation during the follow-up period (median, 184 days; range, 12-819). One patient had a fever the day after stent placement. During the follow-up period 5 patients had secondary stent obstruction because of food residue (n = 2), kinking (n = 1), suspected tumor ingrowth (n = 1), and spontaneous dislodgement (n = 1). Five patients developed obstruction in the second portion of the duodenum. The overall adverse event rate was 36.8% (7/19), mostly with mild severity. CONCLUSIONS: This study revealed that the novel dedicated LAMS used has high technical and clinical success rates for EUS-CDS. The adverse events and patency rates are inferior to the historically reported data of a conventional transpapillary metal stent. Development of a more suitable dedicated LAMS is anticipated.

Retrospective Clinical Study of the Effects of T-Tube Placement for Bile Duct Stricture.

BACKGROUND T-tube placement in the common bile duct (CBD) is a surgical alternative to bile duct reconstruction in cholecystectomy for cholecysto-choledocholithiasis, or gallstones. The aim of this retrospective clinical study was to investigate the incidence of late complications of T-tube placement. MATERIAL AND METHODS Retrospective review identified 35 patients who had T-tube placement during cholecystectomy. Clinical data were collected on surgical indications, patient demographics, and clinical symptoms. Ultrasound (US) was used measure the diameter of the common bile duct (CBD), intrahepatic ducts, and presence or absence of stones in the CBD. Data from laboratory investigations included the aspartate aminotransferase-to-platelet ratio index (APRI), which was used as a non-invasive method to evaluate both cholestasis and liver fibrosis. RESULTS Of the 35 patients included in the study, 33 (94.3%) underwent open cholecystectomy, CBD exploration, and T-tube placement due to cholecysto-choledocholithiasis. The remaining two patients (5.7%) underwent primary CBD repair and T-tube placement secondary to CBD injury. The mean follow-up period after T-tube placement was 69 months. In patients with T-tube placement, the CBD diameters ranged from 4-21 mm, were normal in 20 patients (57.1%), dilated in 15 patients (42.9%), with the mean CBD diameter being 8.91±4.82 mm. No residual or recurrent CBD calculus and no clinical or laboratory evidence of cholangitis or cholestasis were found. CONCLUSIONS A retrospective clinical study at a single surgical center, showed that T-tube placement during open cholecystectomy and CBD exploration was a safe procedure that did not result in late complications.

Long-term outcomes of a newly developed hybrid metal stent for EUS-guided biliary drainage (with videos).

BACKGROUND AND AIMS: Although fully covered self-expandable metal stents (FCSEMSs) have been commonly used for EUS-guided biliary drainage (EUS-BD), FCSEMS migration is a main limitation of this procedure. In the present study we evaluated the technical and clinical success rates, adverse events, and long-term outcomes of a newly developed hybrid stent that has been customized for EUS-BD. METHODS: From September 2011 to May 2015, 54 consecutive patients with biliary obstruction were enrolled in this prospective, observational study. These patients were candidates for alternative BD techniques because of failed ERCP. The hybrid metal stent used for EUS-BD in this study was partially covered, had anchoring flaps, and is commercially available in Korea. RESULTS: EUS-guided hepaticogastrostomy (EUS-HGS) was performed in 21 patients and EUS-guided choledochoduodenostomy (EUS-CDS) in 33 patients. The technical and clinical success rates of EUS-BD were 100% (54/54) and 94.4% (51/54), respectively. Immediate adverse events developed after EUS-BD in 9 patients (16.6%; cholangitis in 3, bleeding in 2, self-limited pneumoperitoneum in 3, and abdominal pain in 1). Proximal or distal stent migration was not observed during the follow-up period (median, 148.5 days; IQR, 79.7-244), and the mean stent patency duration was 166.3 days and 329.1 days in the EUS-HGS and EUS-CDS groups, respectively. CONCLUSIONS: EUS-BD with the hybrid metal stent is technically feasible and can effectively treat biliary obstruction after failed ERCP. EUS-BD with the hybrid metal stent can reduce stent-related adverse events, especially stent migration.

Outcomes after discontinuation of routine use of transanastomotic biliary stents in pediatric liver transplantation at a single site.

Routine use of transanastomotic biliary stents (RTBS) for biliary reconstruction in liver transplantation (LT) is controversial, with conflicting outcomes in adult randomized trials. Pediatric literature contains limited data. This study is a retrospective review of 99 patients who underwent first LT (2005-2014). In 2011, RTBS was discontinued at our center. This study describes biliary complications following LT with and without RTBS. 56 (56%) patients had RTBS. Median age at LT was 1.9 yr (IQR 0.7, 8.6); 55% were female. Most common indication for LT was biliary atresia (36%). Most common biliary reconstruction was Roux-en-Y choledochojejunostomy (75% with RTBS, 58% without RTBS, p = 0.09). Biliary complications (strictures, bile leaks, surgical revision) occurred in 23% without significant difference between groups (20% with RTBS, 28% without RTBS, p = 0.33). Patients with RTBS had routine cholangiography via the tube at 6-8 wk; thus, significantly more patients with RTBS had cholangiograms (91% vs. 19%, p < 0.0001). There was no difference in the number of patients who required therapeutic intervention via endoscopic or percutaneous transhepatic cholangiography (11% with RTBS, 19% no RTBS, p = 0.26). Routine use of RTBS for biliary reconstruction in pediatric LT may not be necessary, and possibly associated with need for costlier, invasive imaging without improvement in outcomes.