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.

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.

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.

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.

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.

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.

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.

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.

Laparoscopic Choledocholithotomy With a Novel Articulating Forceps.

PURPOSE: The aim of this study was to assess the safety and effectiveness of laparoscopic common bile duct (CBD) exploration with a novel articulating forceps. METHODS: A retrospective analysis was carried out of 90 patients who underwent laparoscopic transcholedochal CBD exploration for choledocholithiasis between May 2006 and June 2014. Forty-five patients underwent laparoscopic choledocholithotomy using the routine instruments (group A). Forty-five patients underwent laparoscopic choledocholithotomy using the routine instruments plus the novel articulating forceps (group B). The 2 group populations were similar with regard to demographic data and clinical presentations. RESULTS: Laparoscopic transcholedochal CBD exploration was successful in all 90 patients. The mean diameter of the CBD was 14.42 mm in group A and 14.73 mm in group B (P > .05). The average number of stones extracted per patient was 4.22 in group A and 4.67 in group B (P > .05). The patients in group A had a significantly longer operative time than the patients in group B (109.38 vs 80.49 minutes; P < .01). The intraoperative blood loss was minimal in both groups, and no major complications were observed in either group. The mean hospitalization stay was 6.60 days in group A and 5.58 days in group B (P < .01). CONCLUSION: Laparoscopic transcholedochal CBD exploration with the novel articulating forceps is a safe and effective approach to the management of choledocholithiasis that offers a short operating time and short postoperative hospital stay.

The New Potential for Using Franseen Needles in Interventional EUS.

Objective Adverse events such as bile leakage and bleeding are among the issues that need to be resolved in EUS-guided choledochoduodenostomy (EUS-CDS). To overcome this problem, we developed a new EUS-CDS technique using a 19-G Franseen needle without tract dilation. This study aimed to evaluate the safety and efficacy of the new EUS-CDS technique. Methods This single-center retrospective study included 20 consecutive patients who underwent EUS-CDS for primary drainage using a 19-G Franseen needle between March 2020 and May 2023. The primary endpoint was the technical success rate of EUS-CDS without tract dilation. Results The technical success rate of EUS-CDS was 20/20 (100%). None of the patients required any additional tract dilation, such as by using a balloon or electric cautery. The median procedure time was 7.8 [range, 3.2-19.4] min. No early adverse events were observed. Conclusion The 19-G Franseen needle appeared to have a sufficient dilatory effect during puncturing. This EUS-CDS technique appears to be safe and effective and has the advantages of no adverse events and it is also a simplified procedure, which suggests its potential for widespread use in primary drainage.

Prospective clinical study of endoscopic ultrasound-guided choledochoduodenostomy with direct metallic stent placement using a forward-viewing echoendoscope.

A prospective clinical study was conducted to evaluate the safety, feasibility, and efficacy of endoscopic ultrasound (EUS)-guided choledochoduodenostomy (CDS) with direct metallic stent placement using a prototype forward-viewing echoendoscope. The indication for EUS - CDS in this study was lower biliary obstruction only, and not failed endoscopic biliary drainage, because the aim was to evaluate EUS - CDS for first-line biliary drainage therapy. The technical and functional success rates were 94 % (17 /18) and 94 % (16 /17), respectively. Early complications (focal peritonitis) were encountered in two patients (11 %). No patients developed late complications. EUS - CDS with direct metallic stent placement using a forward-viewing echoendoscope was generally feasible and effective for malignant distal biliary tract obstruction. The forward-viewing echoendoscope was useful, especially for deploying the metallic stent.

Endoscopic ultrasound-guided choledochoduodenostomy and duodenal stenting in patients with unresectable periampullary cancer: one-step procedure by using linear echoendoscope.

OBJECTIVE: Describe a case series of endoscopic ultrasound (EUS)-guided choledochoduodenostomy (EUS-CD) associated with duodenal self-expandable metal stents (SEMS) placement using solely the linear echoendoscope in seven patients with obstructive jaundice and duodenal obstruction due to unresectable periampullary cancer. MATERIAL AND METHODS: EUS-CD in the first portion of the duodenum, associated with duodenal SEMS placement was performed in seven patients with unresectable periampullary cancer with obstructive jaundice and invasive duodenal obstruction. Laboratory tests and clinical follow-up were performed until patient's death. The procedure was performed by an experienced endoscopist under conscious sedation. The puncture position was chosen based on EUS evaluation, at the common bile duct (CBD) above the tumor, through the distal part of the duodenal bulb. After that, the needle was withdrawn and a wire-guided needle knife was used to enlarge the site puncture in the duodenal wall. Then, a partially covered SEMS was passed over the guide, through the choledochoduodenal fistula. Duodenal SEMS placement was performed during the same endoscopic procedure. RESULTS: The procedure was performed in seven patients, ranging between 34 and 86 years. Technical success of EUS-CD, by the stent placement, occurred in 100% of the cases. There were no early complications. Duodenal SEMS placement was effective in 100% of the cases that remained alive after a follow-up of 7 and 30 days. CONCLUSION: The results suggest therapeutic EUS one-step procedure drainage as an alternative for these patients, with good clinical success, feasible technique and safety.

A catheter-based suture-free approach to bilioenteric anastomosis: a pilot study.

Bilioenteric anastomoses are commonly performed during liver transplantation, reconstruction following tumor resection, and repair of bile duct injury. Ischemia plays an important role in both short- and long-term complications related to biliary anastomoses. The authors describe a catheter-based, suture-free approach to bilioenteric anastomosis that aims to reduce or eliminate tissue trauma and foreign material that contribute to anastomotic ischemia. The device uses a novel "umbrella" anchoring mechanism to approximate bowel to the transected bile duct over a percutaneously placed transhepatic catheter. The authors performed an open choledochojejunostomy using the device in 7 pigs. The anastomosis was assessed with cholangiography, gross inspection, and histology at the time of necropsy. The procedure was well tolerated, with no evidence of anastomotic leak in any of the study animals. This alternative catheter-based approach to bilioenteric anastomoses is safe and effective, offers potential advantages over traditional approaches, and can be easily adapted to a minimal access surgery.

Primary closure following laparoscopic common bile duct exploration combined with intraoperative cholangiography and choledochoscopy.

BACKGROUND: Laparoscopic common bile duct exploration (LCBDE) has become one of the main options for treating choledocholithiasis associated with cholelithiasis. Our objective was to assess the short-term outcomes of patients undergoing laparoscopic primary closure of the common bile duct (CBD) compared with laparoscopic choledochotomy plus T-tube drainage. METHODS: We retrospectively studied 137 patients undergoing primary closure following LCBDE (group A) compared with 102 cases with laparoscopic choledochotomy plus T-tube drainage (group B) between January 2007 and January 2010. Intraoperative cholangiography (IOC) and choledochoscopy were performed in all patients. RESULTS: Three patients in group A (2.2%) were converted to open surgery and two (2.0%) in group B because of serious adherence. According to routine IOC, unexpected CBD stones were found in 16 cases (6.8%). The duration of the operation in group A was shorter than in group B (92.4 ± 15.2 vs. 125.7± 32.6 min, P < 0.05), as was length of postoperative stay (3.1± 2.4 vs. 5.7± 4.3 days, P < 0.05). Postoperative bile leakage occurred in six patients (4.5%) in group A and four cases (4.0%) in group B; all of the patients recovered after simple drainage without reoperation. Bile peritonitis was seen in one case after T-tube removal. The median follow-up was 26 months. There were no recurrences. CONCLUSIONS: Laparoscopic primary closure of the CBD is safe and successful for the management of CBD stones. Application of IOC and choledochoscopy to ensure clearance of the CBD and careful suturing are essential for primary closure.

Roux-en-Y choledochojejunostomy using novel magnetic compressive anastomats in canine model of obstructive jaundice.

BACKGROUND: The traditional hand-sewn Roux-en-Y choledochojejunostomy is technically complicated, and the incidence of postoperative complications has remained high. A set of novel magnetic compressive anastomats was introduced to facilitate choledochojejunostomy and improve the prognosis of patients. METHODS: After ligating the common bile duct for 7 days, 16 dogs were randomly divided into two groups (n=8 per group). Anastomats were used in the study group, and the traditional hand-sewn method was used in the control group for standard Roux-en-Y choledochojejunostomy. We compared the operation time, incidence of complications, gross appearance, and pathological disparity in stoma between the two groups in 1-month and 3-month follow-up examinations. RESULTS: The time spent on constructing the anastomosis for the study group was significantly shortened. Although no anastomotic stenosis occurred in the two groups, the narrowing rate of biliary-enteric anastomosis was much higher in the control group. There was one case of bile leakage in the control group, whereas no bile leakage occurred in the study group. A smoother surface, an improved layer apposition, and a lower local inflammatory response were identified in the anastomosis of the study group. CONCLUSION: The structures of the novel magnetic compressive anastomats are simple, and they are time-saving, safe and efficient for performing Roux-en-Y choledochojejunostomy procedures in a canine model of obstructive jaundice.