T-tube or no T-tube for biliary tract reconstruction in orthotopic liver transplantation: an updated systematic review and meta-analysis.

Objectives: Biliary tract reconstruction with or without T-tube is commonly used in orthotopic liver transplantation (OLT). However, the efficacy and safety of T-tube usage remain controversial. This meta-analysis was conducted to assess the latest evidence of clinical outcomes.Methods: Embase, Cochrane Library, PubMed, and Web of Science were systematically searched from inception to 20 January 2021 for eligible studies. The analyses were performed using Review Manager and Stata.Results: A total of 24 trials involving 3320 participants were included in the meta-analysis. Compared with the no T-tube group, there was a higher incidence of overall biliary complications (OR:1.54; 95%CI, 1.06-2.24; P = 0.02), bile leaks (OR:2.34; 95%CI,1.57-3.48; P < 0.0001), cholangitis (OR:2.78; 95%CI,1.19-6.51; P = 0.002), and longer cold ischemia time (MD:22.27; 95%CI,0.80-43.74; P = 0.04) in the T-tube group. Furthermore, the no T-tube group had significantly higher odds of biliary strictures than the T-tube group (OR:0.60; 95%CI, 0.47-0.78; P = 0.0001).Conclusion: T-tube is still not routinely recommended, but is a good choice for OLT patients at high risk of biliary strictures. Notably, the higher rate of biliary complications in the T-tube group did not translate into an increase in endoscopic or re-operative interventions.

Biliary Internal Stents and Biliary Complications in Adult Liver Transplantation.

BACKGROUND: Biliary complications in liver transplantation (LT) can cause significant morbidity or even lead to a potential graft loss and patient mortality. Oftentimes biliary internal stents (ISs) are used at the time of LT to lower the risk for or prevent these biliary complications; however, their efficacy and outcomes remain controversial. METHODS: A retrospective cohort study was conducted on all of the adult patients who underwent a deceased-donor LT (DDLT) with an end-to-end choledococholedocostomy. An IS was placed across the biliary anastomosis, passing through the ampulla. We compared the demographic profiles and various outcomes between the 2 groups (no-IS group vs IS group) and examined risk factors associated with anastomotic biliary complications. RESULTS: The study comprised 350 patients in the no-IS group and 132 patients in the IS group. Anastomotic biliary fistula (ABF) occurred in 5 (1.4%) and 1 (0.8%) patients in the no-IS group and the IS group, respectively (P = .55). Anastomotic biliary stricture (ABS) occurred in 53 (15.1%) and 18 (13.6%) patients, respectively (P = .68). No significant difference was found in the overall biliary complications between the 2 groups (P = .33). In multivariate logistic regression analysis, acute rejection was the only risk factor for ABS (P = .02). One biliary complication-induced mortality occurred in the no-IS group in which the patient died of an ABF-induced hepatic artery pseudoaneurysm rupture. CONCLUSION: The use of biliary ISs in DDLT did not reduce the overall risk for biliary complications, but more research is needed to draw definite conclusions.

Antimicrobial susceptibility of biliary stents do not predict infectious complications after whipple.

BACKGROUND: Postoperative infectious complications after a pancreaticoduodenectomy remain a significant cause of morbidity. Studies have demonstrated that a preoperative biliary stent increases the risk of postoperative infectious complications. Few studies have investigated the specific preoperative biliary stent bacterial sensitivities to preoperative antibiotics and the effect on infectious complications. The goal of this study was to investigate if the presence of a preoperative biliary stent increases the risk of postoperative infectious complications in patients undergoing a pancreaticoduodenectomy. Additionally, we aimed to investigate biliary stent culture sensitivities to preoperative antibiotics and determine if those sensitivities impacted postoperative infectious complications after a pancreaticoduodenectomy. METHODS: A retrospective chart review of patients who had undergone a pancreaticoduodenectomy at a single institution tertiary care center from 2007 to 2018 was performed. Perioperative variables including microbiology cultures from biliary stents were collected and analyzed. RESULTS: A total of 244 patients underwent a pancreaticoduodenectomy. A preoperative biliary stent was present in 45 (18%) patients. Infectious complications occurred in 25% of those patients with a preoperative biliary stent, and 19% of those without (P = .37). Of those patients with a stent that was cultured intraoperatively, 92% grew bacteria and 61% of those were resistant to the preoperative antibiotics administered. Of the patients with a preoperative biliary stent and bacteria resistant to the preoperative antibiotics, 17% developed a postoperative infectious complication, compared with 20% if the bacteria cultured was susceptible to the preoperative antibiotics (P = .64). CONCLUSION: Infectious complications after pancreaticoduodenectomy are a significant cause of morbidity. Stent bacterial sensitivities to preoperative antibiotics did not reduce the postoperative infectious complications in the preoperative biliary stent group suggesting a multifactorial cause of infections.

Percutaneous stent placement for malignant hilar biliary obstruction: side-by-side versus stent-in-stent technique.

BACKGROUND: Currently, side-by-side (SBS) and stent-in-stent (SIS) are the two main techniques for stent deployment to treat hilar biliary obstructions. Previous studies comparing these two techniques are very limited, and thus, no consensus has been reached on which technique is better. The purpose of this study is to compare the clinical efficacy and safety of SBS and SIS deployment via a percutaneous approach for malignant hilar biliary obstruction. METHODS: From July 2012 to April 2019, 65 patients with malignant hilar biliary obstruction who underwent bilateral stenting using either the SBS or SIS techniques were included in this study. Among them, 27 patients underwent SIS stent insertion (SIS group), and the remaining 38 patients underwent SBS stent insertion (SBS group). Technical success, improvement of jaundice, complications, duration of stent patency, and overall survival were evaluated. RESULTS: Technical success was achieved in all patients in the two groups. The serum bilirubin level decreased more rapidly 1 week after the procedures in the SBS group than in the SIS group (P = 0.02). Although the total complication rate did not differ between the two groups, cholangitis was found to be more frequent in the SIS group (P = 0.04). The median stent patency was significantly longer in the SBS group (149 days) than in the SIS group (75 days; P = 0.02). The median overall survival did not significantly differ between the two groups (SBS vs. SIS, 155 days vs. 143 days; P > 0.05). CONCLUSIONS: Percutaneous transhepatic bilateral stenting using either the SBS or SIS technique is safe and effective in the management of malignant hilar biliary obstruction. However, SBS offers a quicker improvement of jaundice, a lower incidence of cholangitis after the procedure, and a longer stent patency period than SIS.

A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study.

BACKGROUND: Biliary decompression can reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for biliary drainage with the aim of improving hepatic function, relieving jaundice, and reducing adverse effects of obstruction. The purpose of this study was to evaluate the performance characteristics of a newly-designed, uncovered metal biliary stent for the palliation of malignant biliary obstruction. METHODS: This post-market, prospective study included patients with biliary obstruction due to a malignant neoplasm treated with a single-type, commercially available uncovered self-expanding metal stent (SEMS). Stents were placed as clinically indicated for palliation of jaundice and to potentially facilitate neo-adjuvant chemotherapy. The main outcome measure was freedom from recurrent biliary obstruction (within the stent) requiring re-intervention within 1, 3, and 6 months of stent insertion. Secondary outcome measures included device-related adverse events and technical success of stent deployment. RESULTS: SEMS were placed in 113 patients (73 men; mean age, 69); a single stent was inserted in 106 patients, and 2 stents were placed in 7 patients. Forty-eight patients survived and/or completed the 6 month study protocol. Freedom from symptomatic recurrent biliary obstruction requiring re-intervention was achieved in 108 of 113 patients (95.6, 95%CI = 90.0-98.6%) at study exit for each patient. Per interval analysis yielded the absence of recurrent biliary obstruction in 99.0% of patients at 1 month (n = 99; 95%CI = 97.0-100%), 96.6% of patients at 3 months (n = 77; 95%CI = 92.7-100%), and 93.3% of patients at 6 months (n = 48; 95%CI = 86.8-99.9%). In total, only 5 patients (4.4%) were considered failures of the primary endpoint. Most of these failures (4/5) were due to stent occlusion from tumor ingrowth or overgrowth. Overall technical success rate of stent deployment was 99.2%. There were 2 cases of stent-related adverse events (1.8%). There were no cases of post-procedure stent migration, stent-related perforation, or stent-related deaths. CONCLUSIONS: This newly designed and marketed biliary SEMS system appears to be effective at relieving biliary obstruction and preventing re-intervention within 6 months of insertion in the overwhelming majority of patients. The device has an excellent safety profile, and associated high technical success rate during deployment. TRIAL REGISTRATION: The study was registered on clinicaltrials.gov on 14 October 2013 and the study registration number is NCT01962168. University of Massachusetts Medical School did not participate in the study.

Six-month Survival of Patients with Malignant Distal Biliary Stricture Following Endoscopic Biliary Stent Procedure and Its Associated Factors.

BACKGROUND: unresectable malignant distal biliary stricture patients require endoscopic biliary stent placement procedure. The survival rate and its associated factors in Indonesia are unknown. OBJECTIVES: To identify 6-month survival of patients with malignant distal biliary stricture following endoscopic biliary stent procedure and its associated factors. METHODS: a retrospective cohort study was conducted using medical records of patients with unresectable malignant distal biliary stricture, which involved caput of pancreas, ampulla of Vater or distal cholangiocarcinoma following endoscopic biliary stent procedure between June 2015 and August 2017 at Cipto Mangunkusumo National Central General Hospital. The cumulative survival was defined by using the Kaplan-Meier curve. Bivariate and multivariate analyses were performed using Cox regression of some factors including failure of biliary stent insertion, bleeding, sepsis, comorbidities, malnutrition, and serum albumin levels. RESULTS: out of total 120 subjects, 85 subjects died within 6 months following the stent procedure with a proportion of 180-day survival of 24% and a median survival of 81 days (CI 95%: 56-106 days). In bivariate analysis, factors of comorbidities, sepsis, malnutrition and albumin levels ≤ 3.0 g/dL had p values of < 0.25; while the subsequent multivariate analysis showed that albumin level of ≤ 3.0 g/dL had HR of 2.73 (CI 95%: 1.48 - 5.05; p = 0.001). CONCLUSION: the 6-month survival following endoscopic biliary stent procedure is 24% with a median survival of 81 days. Albumin level of ≤ 3.0 g/dL has a 2.73 times greater risk for 6-month mortality rate.

Biliary spontaneous dislodgement spiral stent for patients who underwent mechanical lithotripsy.

BACKGROUND: The incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis (PEC) in patients who underwent mechanical lithotripsy (ML) for large stone removal is high (up to 13.3%). One of the main causes is remaining small fragments or sludge that can impair normal biliary drainage. Endoscopic placement of a nasobiliary tube or a conventional plastic biliary stent has been commonly used under such conditions, but the patient may suffer from significant discomfort after the placement of a nasobiliary tube, while additional endoscopy is required for stent removal. We developed a biliary spontaneous dislodgement spiral stent (BSDSS) to overcome those shortcomings. AIM: To evaluate the feasibility, safety, and effectiveness of inserting a BSDSS for patients who underwent ML for large stone removal. METHODS: We conducted a single-center, retrospective, cohort study at West China Hospital, Sichuan University. A total of 91 consecutive patients with large biliary stones (≥ 10 mm) in the common bile duct who underwent ML between November 2017 and July 2018 were included. The 49 eligible patients were divided into the BSDSS group and the nasobiliary tube group. Technical success, post-ERCP adverse events (including PEC, post-ERCP pancreatitis, stone recurrence, BSDSS retention, self-extraction and dislocation of the nasobiliary tube), drainage time, and postoperative stay were measured and compared. RESULTS: Twenty-one patients in the BSDSS group and 28 patients in the nasobiliary tube group were included in the analyses. The baseline characteristics and clinical information were similar in the two groups. Insertions of BSDSS and nasobiliary tube were technically successful in all 49 patients. There was no significant difference in the incidence of overall post-ERCP adverse events between the two groups (4.8% in the BSDSS group vs 17.9% in the nasobiliary tube group, P = 0.219). The median duration of drainage time (3 d in the BSDSS group vs 4 d in the nasobiliary tube group) and length of postoperative stay (4 d in the BSDSS group vs 5 d in the nasobiliary tube group) also did not differ (P = 0.934, and P = 0.223, respectively). CONCLUSION: Endoscopic placement of a BSDSS appears to be feasible, safe and effective for patients who underwent ML for large stone removal.

US Food and Drug Administration and Off-Label Use of Metal Expandable Biliary Stents within the Peripheral Vasculature-Update.

In the past, some medical device manufacturers were obtaining marketing clearance for metallic stents indicated for biliary use; however, these devices were being promoted and used in the peripheral vasculature, creating a patient safety problem. The US Food and Drug Administration (FDA) acted in 2006-2008 to help decrease off-label use of metal expandable biliary stents. This communication describes the early and continued efforts of the FDA to address safety concerns relating to off-label use of metal expandable biliary stents and the status of this issue. An analysis of Medical Device Reporting (MDR) data from January 1, 2005, through December 31, 2018, was conducted to determine the percentage of MDR reports associated with off-label use. The percentage was approximately 90% in 2001-2006 and decreased to < 40% a decade later. In reports associated with off-label use, these devices are still associated with death and serious injury; however, the percentage of injury MDR reports associated with off-label device use has trended down since 2007. Whereas 92%-95% of reported serious injuries were with off-label placement in 2005-2007, 43%-79% of injuries were with off-label placement in 2008-2018. Collaborative efforts among the FDA, manufacturers, and physicians appear to have made progress in addressing this issue.

No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.

OBJECTIVE: To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction. METHODS: Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival. RESULTS: A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3). CONCLUSION: In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival. KEY POINTS: • Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. • Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. • Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.

Management of Difficult Bile Duct Stones by Large Balloon, Cholangioscopy, Enteroscopy and Endosonography.

Endoscopic management of bile duct stones is now the standard of care, but challenges remain with difficult bile duct stones. There are some known factors associated with technically difficult bile duct stones, such as large size and surgically altered anatomy. Endoscopic mechanical lithotripsy is now the standard technique used to remove large bile duct stones, but the efficacy of endoscopic papillary large balloon dilatation (EPLBD) and cholangioscopy with intraductal lithotripsy has been increasingly reported. In patients with surgically altered anatomy, biliary access before stone removal can be technically difficult. Endotherapy using two new endoscopes is now utilized in clinical practice: enteroscopy-assisted endoscopic retrograde cholangiopancreatography and endoscopic ultrasound-guided antegrade treatment. These new approaches can be combined with EPLBD and/or cholangioscopy to remove large bile duct stones from patients with surgically altered anatomy. Since various endoscopic procedures are now available, endoscopists should learn the indications, advantages and disadvantages of each technique for better management of bile duct stones.

Percutaneous transpapillary biliary stent placement for distal malignant biliary obstruction: Outcomes and survival analysis.

BACKGROUND/AIMS: For distal malignant biliary obstruction (MBO), a percutaneous metal stent is usually inserted by the transpapillary method. However, stent-related complications and recurrent biliary obstruction following transpapillary stent placement are concerns, and survival analysis of patients with distal MBO has rarely been done. MATERIALS AND METHODS: From January 2012 to March 2016, 104 patients underwent transpapillary uncovered metal stent placement for distal MBO at our institution. Clinical success, complications, recurrent biliary obstruction rates, and predictors of survival were analyzed. RESULTS: Of the total 104 patients, clinical success after stent insertion was achieved in 93 patients (90.3%). Major complications were observed in 24 patients (23.1%), which were as follows: cholangitis in 19 patients; pancreatitis in four patients; and biloma in one patient. Recurrent biliary occlusion was observed in 28 patients (26.9%). The median overall survival period was 162 days. The 3-, 6-, and 12-month overall survival rates after stent insertion were 64.4%, 41.3%, and 10.6%, respectively. Results of multivariate analysis indicated that metastatic carcinoma compared with ampullary carcinoma (HR=3.82; 95% CI, 1.30-11.24; p=0.015) and longer biliary stricture (HR=1.04; 95% CI, 1.02-1.06; p<0.001) were independent risk factors for worse survival after metal stent insertion. CONCLUSION: Transpapillary stent placement was found to be effective with acceptable complication rates for treating distal MBO. Primary tumor and length of biliary stricture were found to be statistically significant independent prognostic factors for survival.

Novel Application of Internal-External Drainage Catheter as Biliary Stent for Percutaneous Transhepatic Treatment of Biliary Strictures in Living Donor Liver Transplantation Recipient Patients.

OBJECTIVES: Although endoscopic management is considered as the first-line treatment for biliary strictures, it may be challenging in living donor liver transplant recipients due to the complex nature of duct-to-duct reconstruction. In this study we present the use of a pigtail drainage catheter as a biliary stent to treat biliary strictures after a living donor liver transplant. METHODS: Twenty-seven patients with biliary strictures were treated with our novel technique. In this technique, a pigtail catheter was trimmed into 3 parts (proximal, middle, and distal portions). A suture string was passed through the distal hole of the middle portion, which was then reversed and used as a stent while the proximal portion was used as a pusher. Following balloon dilation of the stenotic segment, the distal, reversed middle, and proximal portions were loaded over the guidewire. After proper placement of the stent, the retractor suture string, pusher, and guidewire were removed. The stent was removed during the third or fourth month of placement through endoscopic retrograde cholangiopancreatography (ERCP) in all patients. RESULTS: No significant complications developed during the procedure or follow-up period. Ten patients required re-stenting by ERCP during the same session. The mean follow-up period was 2 years. Cholestase enzymes and bilirubin levels were within normal limits in all patients during follow-up. CONCLUSION: Stents derived from drainage catheter facilitate treatment of biliary strictures in patients not eligible for the retrograde approach. This stent is cheap, easy to implement, can be easily removed by ERCP, and re-stenting can be applicable in retrograde if needed.

Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial.

BACKGROUND AND AIMS: Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within an acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully-covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx. METHODS: Patients with pancreatic cancer and planned NATx who need treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMSs versus UCSEMSs. The primary endpoint was sustained biliary drainage, defined as the absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery or at 1 year. RESULTS: The intention-to-treat population included 119 patients (59 FCSEMSs, 60 UCSEMSs). Sustained biliary drainage was equally successful with FCSEMSs and UCSEMSs (72.2% vs 72.9%, noninferiority P = .01). Reasons for FCSEMS and UCSEMS failure differed significantly between the groups and included tumor ingrowth in 0% versus 16.7% (P < .01), and stent migration in 6.8% versus 0% (P = .03), respectively. Serious adverse event rates related to stent placement were not significantly different in both groups (23.7% [14/59] vs 20.0% [12/60], P = .66), as were acute cholecystitis rates when the gallbladder was in situ (9.3% [4/43] vs 4.8% [2/42], P = .68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4-cm stent length and presence of the gallbladder. CONCLUSION: FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in patients with pancreatic cancer receiving NATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder. (Clinical trial registration number: NCT02238847.).

Combination of endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography-guided biliary drainage in malignant hilar biliary obstruction.

Adequate biliary drainage (BD), defined as more than 50% of liver volume drained, is an ideal BD method in patients with advanced and unresectable malignant hilar biliary obstruction (MHBO). Endoscopic retrograde cholangiopancreatography (ERCP) with multi-segmental BD is technically challenging. ERCP with percutaneous biliary drainage (PTBD) or PTBD alone has cumbersome maintenance of PTBD line and external bag. The utility of EUS-guided BD (EUS-BD) has risen significantly over last 5 years mostly in the clinical setting of distal bile duct obstruction. Information on EUS-BD for malignant hilar biliary obstruction (MHBO) is thus far limited to only two small studies. This review suggests a new concept of a combination of ERCP and EUS-BD (CERES) for BD in MHBO as a primary BD method whereby ERCP with a single self-expandable metal stent (SEMS) is placed into either the right or the left intrahepatic bile duct (IHD). If SEMS is placed in the right biliary system, EUS-guided hepaticogastrostomy (EUS-HGS) can subsequently be carried out. However, if the stent is placed into the left biliary system, EUS-guided hepaticoduodenostomy (EUS-HDS) is done. For MHBO with non-functioning right lobe of the liver, EUS-HGS is carried out after failed ERCP, or primary HGS can be carried out in the left lobe of liver. For MHBO with non-functioning left lobe of the liver, EUS-HDS is carried out after failed transpapillary stenting of the right lobe by ERCP. Based on our experience, CERES is promising as it can fulfil gaps of both PTBD and ERCP by allowing internal drainage that can circumvent the inconvenience associated with PTBD and offer higher technical success rate compared to ERCP with bilateral SEMS placement.

Prospective comparison of endoscopic bilateral stent-in-stent versus stent-by-stent deployment for inoperable advanced malignant hilar biliary stricture.

BACKGROUND AND AIMS: Although the efficacy of palliative bilateral biliary drainage using self-expandable metal stents has been demonstrated, it is unclear which bilateral method is optimal for advanced malignant hilar biliary strictures (MHSs). This pilot study compared bilateral stent-in-stent (SIS) with stent-by-stent (SBS) deployment for advanced MHSs. METHODS: Patients with inoperable high-grade MHSs were enrolled in this prospective randomized multicenter study. The primary outcome was the rate of adverse events, whereas secondary outcomes were technical and clinical success, reintervention, therapeutic outcomes, stent patency, and survival duration. RESULTS: This study randomized 69 of 74 pathologically diagnosed patients to the SIS (n = 34) or SBS (n = 35) groups. The total adverse event rate after stent deployment did not differ between the 2 groups (23.5% in the SIS group vs 28.6% in the SBS group, P = .633). The primary technical success rate was 100% (34/34) and 91.4% (32/35) in the SIS and SBS groups, respectively (P = .081). The clinical success rate was 94.1% (32/34) and 90.6% (29/32), respectively (P = .668). The stent patency rate at 3 months was 85.3% in the SIS group and 65.7% in the SBS group (P = .059). At 6 months, the stent patency rate was 47.1% and 31.4%, respectively (P = .184). The median cumulative stent patency and survival probability did not differ between the 2 groups. CONCLUSIONS: Efficacy of bilateral SIS and SBS deployment may be similar in terms of total adverse events, technical and clinical success, stent patency, and survival. The stent patency rates at 3 and 6 months was higher in the SIS group without statistical difference. (Clinical trial registration number: NCT01141088.).

Primary Clinical Application of Y-Shaped Jogged Stent Implantation in Patients with Malignant Hilar Biliary Obstruction.

OBJECTIVE: To assess the feasibility, safety, and efficacy of Y-shaped jogged stent in patients with malignant hilar biliary obstruction. METHODS: A total of 196 patients with malignant hilar biliary obstruction treated by biliary tract stent implantation from August 2010 to August 2017 were retrospectively reviewed. Seventeen consecutive patients who were treated with Y-shaped jogged stent implantation were identified as the Y-shaped jogged stent implantation group. Seventeen matched patients undergoing unilateral stent placement combined with percutaneous transhepatic cholangial drainage (PTCD) were enrolled as the control group. Baseline characteristics of patients, stent patency time, and survival time were compared. RESULTS: There was no significant difference in the age, gender, tumor type and stage, biliary obstruction classification, bilirubin level at diagnosis, presence of metastasis, or chemotherapy between the Y-stent group and the control group (P > 0.05). One week after surgery, the reduction rate of bilirubin was significantly higher in the Y-stent group (88.2% vs 53.0%, P < 0.05). The mean stent patency time was longer in the Y-stent group (7.3 ± 1.0 months vs 5.7 ± 0.9 months, P < 0.05). The mean survival time of the Y-stent group (9.1 ± 1.5 months) was longer than the control group (7.2 ± 1.1 months, P > 0.05). There was no severe complication occurred in both two groups. CONCLUSION: Y-shaped jogged stent implantation was a safe, feasible, and effective approach in the treatment of patients with malignant hilar biliary obstruction, with the significantly prolonged stent patency time and survival time.

Comparison of long-term efficacy between endoscopic and percutaneous biliary drainage for resectable extrahepatic cholangiocarcinoma with biliary obstruction: A systematic review and meta-analysis.

BACKGROUND/AIM: For resectable extrahepatic cholangiocarcinoma with biliary obstruction, it remains a controversy whether to choose percutaneous transhepatic biliary drainage (PTBD) or endoscopic biliary drainage (EBD). A systematic review was conducted to compare the long-term efficacy between the two techniques. MATERIALS AND METHODS: Eligible studies were searched from January 1990 to May 2018, comparing the long-term efficacy between EBD and PTBD for extrahepatic cholangiocarcinoma. Primary end point was overall survival (OS) rate, and secondary end points included postoperative severe complications and seeding metastasis. Effect size on outcomes was calculated using a fixed- or random-effect model, accompanied with hazard ratio (HR) and 95% confidence interval (CI). RESULT: Six studies were included in this meta-analysis. Meta-analysis showed that EBD was superior to PTBD in OS (HR = 0.70, 95% CI 0.59-0.84,P= 0.0002). But subgroup results showed that the superiority disappeared in distal cholangiocarcinoma (HR = 0.76, 95% CI 0.56-1.01,P= 0.06). Other prognostic factors such as intraoperative blood transfusion, lymphatic metastasis and seeding metastasis, were inconsistent between groups. In addition, regional disparity was obviously apparent between Japanese and non-Japanese studies. CONCLUSION: The conclusion that EBD was superior to PTBD in OS for resectable extrahepatic cholangiocarcinoma with biliary obstruction is less convincing, and more trials need to be conducted in future.