International study of endoscopic management of distal malignant biliary obstruction combined with duodenal obstruction

Objective: Endoscopic transpapillary or endoscopic ultrasound (EUS)-guided stent placement is used for nonresectable distal malignant biliary obstruction. We conducted a retrospective study to evaluate endoscopic biliary drainage in patients with duodenal obstruction.

Methods: We included consecutive patients who underwent endoscopic biliary drainage combined with a duodenal stent at 16 referral centers in four Asian countries. The primary outcome was time to recurrent biliary obstruction (TRBO). We assessed TRBO according to the sequence of biliary and duodenal obstruction (group 1/2/3, biliary obstruction first/concurrent/duodenal obstruction first, respectively) or the location of duodenal obstruction (type I/II/III, proximal to/affecting/distal to the ampulla, respectively). We also evaluated functional success and adverse events.

Results: We included 110 patients (group1/2/3, 67/29/14 patients; type I/II/III, 45/46/19 patients; endoscopic retrograde cholangiopancreatography [ERCP]/EUS-guided choledocoduodenostomy/EUS-guided hepaticogastrostomy, 90/10/10 patients, respectively). The median TRBO of all cases was 450 days (interquartile range, 212–666 days) and functional success was achieved in 105 cases (95%). The TRBO did not differ significantly by the timing or location of duodenal obstruction (p?=?.30 and .79, respectively). The TRBO of metal stents (n?=?96) tended to be longer compared with plastic stents (n?=?14, p?=?.083). Compared with ERCP, EUS-guided biliary drainage was associated with a higher rate of adverse events.

Conclusion: Transpapillary or transmural endoscopic biliary drainage with a duodenal stent was effective, irrespective of the timing or location of duodenal obstruction. A prospective study is required considering the tradeoff of technical success rate, stent patency, and adverse events (ClinicalTrials.gov number, NCT02376907).     

Clinical outcome after biliary drainage for metastatic colorectal cancer: Survival analysis and prognostic factors

IntroductionBiliary obstruction secondary to colorectal cancer liver metastases is associated with a poor prognosis especially when chemotherapy cannot be re-started. The aim of this study was to determine the survival after biliary drainage and the associated prognostic factors.MethodsPatients from two French centers were included retrospectively after first biliary endoscopic retrograde cholangiopancreatography or percutaneous transhepatic cholangiography drainage for biliary obstruction secondary to liver metastases of colorectal cancer, occurring during chemotherapy.ResultsThe final analysis included 69 patients. Overall median survival was 115 days. In univariate analysis, a previous liver surgery, technical and functional success of drainage and restarted chemotherapy were significantly associated with an improved survival. Chemotherapy was restarted after a median of 27 days. When drainage was efficient, survival improved from 33 to 262 days (p < 0.001). In multivariate analysis, significant protective factors for survival included previous a hepatectomy (HR 0.41) and functional success of the drainage (HR 0.29). Predictive factors for death included increased lines of chemotherapy (HR 1.68) and fever before drainage (HR 2.97).ConclusionsThis is the first study concerning the benefits of biliary drainage for malignant biliary obstruction during the course of chemotherapy for colorectal cancer. A successful biliary drainage leads to improved survival and allows achievement of chemotherapy for 70% of patients.     

Endoscopic biliary stent insertion through specialized duodenal stent for combined malignant biliary and duodenal obstruction facilitated by stent or PTBD guidance

Objectives: Endoscopic stenting for combined malignant biliary and duodenal obstruction is technically demanding. However, this procedure can be facilitated when there is guidance from previously inserted stent or PTBD tube. This study aimed to evaluate the feasibility and clinical success rate of endoscopic placement of biliary self-expandable metal stent (SEMS) through duodenal SEMS in patients with combined biliary and duodenal obstruction due to inoperable or metastatic periampullary malignancy.

Materials and methods: A total of 12 patients with combined malignant biliary and duodenal stricture underwent insertion of biliary SEMS through the mesh of specialized duodenal SEMS from July 2012 to October 2016. Technical and clinical success rate, adverse events and survival after completion of SEMS insertion were evaluated.

Results: The duodenal strictures were located in the first portion of the duodenum in four patients (Type I), in the second portion in three patients (Type II), and in the third portion in five patients (Type III). Technical success rate of combined metallic stenting was 91.7%. Insertion of biliary SEMS was guided by previously inserted biliary SEMS in nine patients, plastic stent in one patient, and PTBD in two patients. Clinical success rate was 90.9%. There were no early adverse events after the procedure. Mean survival period after combined metallic stenting was 91.9 days (range: 15–245 days).

Conclusions: Endoscopic placement of biliary SEMS through duodenal SEMS is feasible with high success rates and relatively easy when there is guidance. This method can be a good alternative for palliation in patients with combined biliary and duodenal obstruction.     

Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01)

Introduction:Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a novel drainage option for patients with an inaccessible papilla. Although EUS-HGS has clinical benefits in patients for whom endoscopic retrograde cholangiopancreatography (ERCP) has failed, the rates of adverse events (AEs) associated with EUS-HGS, such as bile peritonitis and stent migration, are higher than for other procedures. The development of a dedicated system for EUS-HGS is therefore desirable to reduce the rate of AEs. We developed a dedicated system for EUS-HGS (HG01 system) which is composed of a 19-gauge needle, 0.025-inch guidewire, a thin delivery system for tract dilation, and an antimigration metal stent. This study is designed to evaluate the efficacy and safety of EUS-HGS using the HG01 system in malignant biliary obstruction.Methods/design:This is a single-arm multicenter prospective study involving 40 patients across six tertiary centers in Japan. Patients with an unresectable malignant biliary obstruction in whom biliary drainage with ERCP failed, is not possible, or is very difficult will be registered in the study. The primary endpoint is the clinical success rate. The secondary endpoints are the technical success rate, procedure-related AE rate, procedure time, procedure success rate using only the HG01 system, stent patency rate, re-intervention success rate, re-intervention method, survival rate, and distance of movement of the stent position.Discussion:We expect use of the HG01 system to reduce the rate of AEs during EUS-HGS, especially bile leakage and stent migration. If the efficacy and safety of EUS-HGS using the HG01 system is confirmed in the present study, it is likely to be considered the first-choice device for use during EUS-HGS.     

Relief of jaundice in malignant biliary obstruction: When should we consider endoscopic ultrasonography-guided hepaticogastrostomy as an option?

BackgroundSince it was first described in 2001, endoscopic ultrasonography-guided biliary drainage (EUS-BD) has emerged as an alternative procedure for achieving an endoscopic internal drainage in case of endoscopic retrograde cholangiopancreatography (ERCP) failure. Biliary drainage can be achieved by either a transduodenal extrahepatic approach through EUS-guided choledochoduodenostomy (EUS-CDS), or a transgastric intrahepatic approach, namely EUS-guided hepaticogastrostomy (EUS-HGS) which already holds a remarkable place in the treatment of patients with malignant biliary obstruction.Data sourcesFor this review we did a comprehensive search of PubMed/MEDLINE from inception to May 31, 2021 for papers with a significant sample size (at least 20 patients enrolled) dealing with EUS-HGS. Data on technical success, clinical success and rate of adverse events were collected.ResultsA total of 22 studies with different design, comprising 874 patients, were included. Technical success was achieved in about 96% of cases (ranging from 65% to 100%). Clinical success was obtained in almost 91% of cases (ranging from 76% to 100%). Overall rate of adverse events was 19% (ranging from 0% to 35%). Abdominal pain, self‐limiting pneumoperitoneum, bile leak, cholangitis, bleeding, perforation and intraperitoneal migration of the stent were the most common.ConclusionsDespite both safety and efficacy profile, at the moment HGS still remains a challenging procedure at every single step and must therefore be conducted by a very experienced endoscopist in interventional EUS and ERCP procedures, who is able to deal with the possible severe adverse events of this procedure. A rapid introduction in clinical practice of dedicated devices is desiderable.     

Fully covered,self-expandable metal stents for first-step endoscopic treatment of biliary leaks secondary to hepato-biliary surgery: A retrospective study

BackgroundFully covered self-expanding metal stents are now being used to treat benign biliary diseases.AimsTo assess the outcomes of these stents as first-step therapy in patients with biliary leaks secondary to hepato-biliary surgery.MethodsThirty patients (56.7% males; mean age: 60.2 ± 13 years) were retrospectively evaluated. The data collected included technical and clinical success, adverse events and follow-up findings (1, 3 and 6 months).ResultsTechnical and clinical success rates were 100%. One early mild post-procedure pancreatitis occurred and resolved spontaneously. Three late stent distal migrations occurred, however cholangiography showed correct leak sealing in all patients. Stents were removed after a mean of 55.9 days. During follow-up no other complications occurred.ConclusionIn our experience fully covered self-expanding metal stent placement was safe and efficacious as first-step therapy for post-operative biliary leaks. However, prospective comparative studies with plastic stents are required to validate these findings.     

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.     

Endoscopic retrograde cholangiopancreatography drainage for palliation of malignant hilar biliary obstruction — stent-in-stent or side-by-side? A systematic review and meta-analysis

BACKGROUNDBiliary drainage, either by the stent-in-stent (SIS) or side-by-side (SBS) technique, is often required when treating a malignant hilar biliary obstruction (MHBO). Both methods differ from each other and have distinct advantages.AIMTo compare both techniques regarding their efficacy and safety in achieving drainage of MHBO.METHODSA comprehensive search of multiple electronic databases (MEDLINE, Embase, LILACS, BIREME, Cochrane) was conducted and grey literature from their inception until December 2020 with no restrictions regarding the year of publication or language, since there was at least an abstract in English. The included studies compared SIS and SBS techniques through endoscopic retrograde cholangiopancreatography. Outcomes analyzed included technical and clinical success, early and late adverse events (AEs), stent patency, reintervention, and procedure-related mortality.RESULTSFour cohort studies and one randomized controlled trial evaluating a total of 250 patients (127 in the SIS group and 123 in the SBS group) were included in this study. There were no statistically significant differences between the two groups concerning the evaluated outcomes, except for stent patency, which was higher in the SIS compared with the SBS technique [mean difference (d) = 33.31; 95% confidence interval: 9.73 to 56.90, I² = 45%, P = 0.006].CONCLUSIONThe SIS method showed superior stent patency when compared to SBS for achieving bilateral drainage in MHBO. Both techniques are equivalent in terms of technical success, clinical success, rates of both early and late AEs, reintervention, and procedure-related mortality.     

Endoscopic ultrasound-guided vs ERCP-guided biliary drainage for malignant biliary obstruction: A up-to-date meta-analysis and systematic review

Endoscopic ultrasound-guided biliary drainage (EUS-BD) is being used increasingly as an alternative treatment for malignant biliary obstruction (MBO). However, few studies have compared EUS-BD and endoscopic retrograde cholangiopancreatography biliary drainage (ERCP-BD). We searched the PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases until 1 November 2020 for studies comparing EUS-BD versus ERCP-BD. The primary outcomes of interest in this study were technical and clinical success. Nine studies involving 634 patients were included in this meta-analysis. Regarding technical and clinical success, there were no significant differences between EUS-BD and ERCP-BD (odds ratio [OR], 0.76; 95% CI: 0.30–1.91; OR, 1.45, 95% confidence interval [CI], 0.66–3.16, respectively). EUS-BD was associated with significantly less reintervention vs ERCP-BD (OR, 0.36, 95% CI, 0.15–0.86). Regarding adverse events, the rates were similar for EUS-BD and ERCP-BD (OR: 0.75, 95% CI, 0.45–1.24). There were no significant differences in the types of adverse events (stent occlusion, stent migration, stent dysfunction, and duration of stent patency) between the two techniques. EUS-BD was associated with lower reintervention rates compared with ERCP-BD, with comparable safety and efficacy outcomes. However, more high-quality randomized trials are required.     

Radiofrequency ablation for management of malignant biliary obstruction: a single-center experience and review of the literature

Background: Radiofrequency ablation (RFA) causes coagulative necrosis of tissue and may be beneficial prior to biliary stenting. We report our experience using RFA for malignant biliary obstruction and review the literature.

Methods: Retrospective analysis of all patients undergoing RFA for malignant biliary obstruction over the last two years. Success, complications and re-intervention following RFA were assessed. Controls were age, sex and disease matched who had stenting alone.

Results: 31 patients were included and 15 patients underwent biliary RFA prior to stenting (median age 78 years, 8 females). 14 patients had pancreatic cancer, 13 cholangiocarcinoma (6 hilar lesions) and 4 malignant disease invading the bile duct. Adverse events included acute pancreatitis (n = 2) and bacteremia in (n = 1). Median duration of intervention free survival was 220 days in the RFA group compared to 106.5 days in controls (hazard ratio 2.4, 95% CI 1.1 – 5.3, p = 0.025). Multivariable Cox proportional hazard analysis showed survival was associated with RFA (hazard ratio 2.55, 95% CI 1.09–5.96, p = 0.026) but not age, site or type of malignancy.

Conclusion: Biliary RFA is a technically feasible with a low adverse event rate and is associated with increased survival. Multi-centre randomized controlled trials are required.     

Effectiveness of combined biliary and duodenal stenting in patients with malignant biliary and duodenal obstruction

Abstract

Introduction. Concomitant biliary and duodenal obstructions are not uncommon complications in patients with gastroduodenal or pancreatobiliary malignancies. Alleviation of obstruction is very important for the palliation of inoperable patients. We studied the clinical outcomes of combined biliary and duodenal stenting. Methods. Between January 2003 and January 2010, the records of 24 patients who underwent biliary and duodenal stent placement due to inoperable malignant biliary and duodenal obstruction were reviewed retrospectively. Results. Of the 24 patients, a duodenal stent was placed after biliary stenting in 23 patients and a biliary stent was placed after duodenal stenting in one patient. Biliary stents were placed endoscopically (33 cases) or percutaneously (14 cases). Duodenal stents were placed endoscopically by fluoroscopic guidance in all patients. Oral feeding was possible at a mean of 2.7 ± 1.2 days (range, 1–6 days) after duodenal stenting. Acute pancreatitis and acute cholangitis developed in three patients and one patient, respectively, as early complications after biliary stenting. Biliary stent occlusion was developed in 12 patients and was treated successfully by stent reinsertion. As complications of duodenal stent, one case of stent migration and five cases of stent occlusion developed. Median survival after initial bilioduodenal stenting was 195.5 days (range, 21–725 days). Stent patency was well maintained in 83.3% of patients after combined stent placements while patients were alive. Conclusion. Combined biliary and duodenal stenting seems to be safe and effective in palliation of inoperable malignant biliary and duodenal obstruction.     

Endoscopic salvage therapy after failed biliary cannulation using advanced techniques: A concise review

Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) begins with successful biliary cannulation. However, it is not always be successful. The failure of the initial ERCP is attributed to two main aspects: the papilla/biliary orifice is endoscopically accessible, or it is inaccessible. When the papilla/biliary orifice is accessible, bile duct cannulation failure can occur even with advanced cannulation techniques, including double guidewire techniques, transpancreatic sphincterotomy, needle-knife precut papillotomy, or fistulotomy. There is currently no consensus on the next steps of treatment in this setting. Therefore, this review aims to propose and discuss potential endoscopic options for patients who have failed ERCP due to difficult bile duct cannulation. These options include interval ERCP, percutaneous-transhepatic-endoscopic rendezvous procedures (PTE-RV), and endoscopic ultrasound-assisted rendezvous procedures (EUS-RV). The overall success rate for interval ERCP was 76.3% (68%-79% between studies), and the overall adverse event rate was 7.5% (0-15.9% between studies). The overall success rate for PTE-RV was 88.7% (80.4%-100% between studies), and the overall adverse event rate was 13.2% (4.9%-19.2% between studies). For EUS-RV, the overall success rate was 82%-86.1%, and the overall adverse event rate was 13%-15.6%. Because interval ERCP has an acceptably high success rate and lower adverse event rate and does not require additional expertise, facilities, or other specialists, it can be considered the first choice for salvage therapy. EUS-RV can also be considered if local experts are available. For patients in urgent need of biliary drainage, PTE-RV should be considered.     

Adjuvant therapies using biliary stenting for malignant biliary obstruction

The aim of this study was to analyze the patency of expandable metallic stents in malignant biliary obstruction and to evaluate the efficacy of adjuvant therapy accompanied by biliary stenting. We analyzed 29 patients in whom bile duct stenting was performed for malignant biliary obstruction. Their types of disease were: hilar ductal carcinoma (n = 8), gallbladder carcinoma (n = 11), and pancreatic carcinoma (n = 10). Initially, 46 expandable metallic stents were placed in 29 patients. In 23 of the 29 patients, adjuvant therapy was administered. Seventeen patients underwent radiotherapy, and 16 patients received various systemic chemotherapies. In principle, hyperthermia was performed twice a week, simultaneously with radiotherapy. Patient survival and the probability of stent patency were calculated using actuarial life table analysis. There was no significant difference in stent patency among the patients according to type of disease. Hyperthermia did not influence the stent patency rate. The median stent patency time was significantly greater in the chemo-radiation group than in the no-adjuvant therapy group: 182 days versus 68 days, respectively (P = 0.017). Moreover, a significant increase was seen in the median survival time in the chemo-radiation group: 261 days versus 109 days (P = 0.0337). Complications occurred in 9 patients (31.0%). Stent occlusion occurred in 6 patients (20.7%), with all of these patients managed successfully using a transhepatically placed new expandable metallic stent, employing the stent-in-stent method. Stent migration occurred in 2 patients after radiotherapy. Adjuvant therapies such as radiotherapy and systemic chemotherapy, in combination with stent insertion, resulted in an increase in the patency period of expandable metallic stents and in increased patient survival time.     

Inutility of endoscopic sphincterotomy to prevent pancreatitis after biliary metal stent placement in the patients without pancreatic duct obstruction

Abstract

Background: The incidence of post-ERCP pancreatitis (PEP) has been reported to be significantly higher in patients without main pancreatic duct (MPD) obstruction who undergo transpapillary biliary metal stent (MS) placement than in those with ordinary ERCP setting.

Objective: To evaluate the benefit of endoscopic sphincterotomy (ES) prior to MS placement in preventing PEP in patients with distal malignant biliary obstruction (MBO) without MPD obstruction.

Materials and methods: In total, 160 patients who underwent initial MS placement for MBO were enrolled. Eighty-two patients underwent ES immediately prior to MS placement, whereas 78 underwent MS placement without ES. An inverse probability of treatment weighting method was adopted to adjust the differences of the patients’ characteristics. The primary outcome was the incidence of PEP. The secondary outcomes included the incidence of other adverse events (bleeding, cholangitis, perforation and stent dislocation) and time to recurrent biliary obstruction.

Results: The incidence of PEP was 26.8% in the ES and 23.1% in the non-ES (unadjusted odds ratio [OR] [95%CI]: 1.22, [0.60–2.51], adjusted OR [95%CI]: 1.23, [0.53–2.81], p?=?.63). Logistic-regression analysis revealed no factors that could be attributed to the occurrence of PEP. The incidence of other adverse events was not different between the groups. The median time to recurrent biliary obstruction was 131 (2–465) days and 200 (4–864) days in the ES and non-ES, respectively (p?=?.215).

Conclusions: ES prior to MS placement for patients with distal MBO without MPD obstruction does not reduce the incidence of PEP.     

Biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage

BackgroundComplementary to percutaneous intra-abdominal drainage, percutaneous transhepatic biliary drainage (PTBD) might ameliorate healing of pancreatic fistula and biliary leakage after pancreatoduodenectomy by diversion of bile from the site of leakage. This study evaluated technical and clinical outcomes of PTBD for this indication.MethodsAll patients undergoing PTBD for leakage after pancreatoduodenectomy were retrospectively evaluated in two tertiary pancreatic centers (2014–2019). Technical success was defined as external biliary drainage. Clinical success was defined as discharge with a resolved leak, without additional surgical interventions for anastomotic leakage other than percutaneous intra-abdominal drainage.ResultsFollowing 822 pancreatoduodenectomies, 65 patients (8%) underwent PTBD. Indications were leakage of the pancreaticojejunostomy (n = 25; 38%), hepaticojejunostomy (n = 15; 23%) and of both (n = 25; 38%). PTBD was technically successful in 64 patients (98%) with drain revision in 40 patients (63%). Clinical success occurred in 60 patients (94%). Leakage resolved after median 33 days (IQR 21–60). PTBD related complications occurred in 23 patients (35%), including cholangitis (n = 14; 21%), hemobilia (n = 7; 11%) and PTBD related bleeding requiring re-intervention (n = 4; 6%). In hospital mortality was 3% (n = 2).ConclusionAlthough drain revisions and complications are common, PTBD is highly feasible and appears to be effective in the treatment of biliopancreatic leakage after pancreatoduodenectomy.     

Endoscopic ultrasound-guided vs endoscopic retrograde cholangiopancreatography biliary drainage for obstructed distal malignant biliary strictures: A systematic review and meta-analysis

BACKGROUND For palliation of malignant biliary obstruction(MBO), the gold-standard method of biliary drainage is endoscopic retrograde cholangiopancreatography(ERCP)with the placement of metallic stents. Endoscopic ultrasound(EUS)-guided drainage is an alternative that is typically reserved for cases of ERCP failure.Recently, however, there have been robust randomized clinical trials(RCTs)comparing EUS-guided drainage and ERCP as primary approaches to MBO.AIM To compare EUS guidance and ERCP in terms of their effectiveness and safety in palliative biliary drainage for MBO.METHODS This was a systematic review and meta-analysis, in which we searched the MEDLINE, Excerpta Medica, and Cochrane Central Register of Controlled Trials databases. Only RCTs comparing EUS and ERCP for primary drainage of MBO were eligible. All of the studies selected provided data regarding the rates of technical and clinical success, as well as the duration of the procedure, adverse events, and stent patency. We assessed the risk of biases using the Jadad score and the quality of evidence using the Grading of Recommendations Assessment,Development and Evaluation criteria.RESULTS The database searches yielded 5920 records, from which we selected 3 RCTs involving a total of 222 patients(112 submitted to EUS and 110 submitted to ERCP). In the EUS and ERCP groups, the rate of technical success was 91.96%n and 91.81%, respectively, with a risk difference(RD) of 0.00%(95%CI:-0.07, 0.07;P = 0.97; I~2 = 0%). The clinical success was 84.81% and 85.53% in the EUS and ERCP groups, respectively, with an RD of-0.01%(95%CI:-0.12, 0.10; P = 0.90; I~2 =0%). The mean difference(MD) for the duration of the procedure was-0.12%(95%CI:-8.20, 7.97; P = 0.98; I~2 = 84%). In the EUS and ERCP groups, there were14 and 25 adverse events, respectively, with an RD of-0.06%(95%CI:-0.23, 0.12; P= 0.54; I~2 = 77%). The MD for stent patency was 9.32%(95%CI:-4.53, 23.18; P =0.19; I~2 = 44%). The stent dysfunction rate was significantly lower in the EUS t group(MD =-0.22%; 95 CI:-0.35,-0.08; P = 0.001; I~2 = 0%).CONCLUSION EUS represents an interesting alternative to ERCP for MBO drainage,demonstrating lower stent dysfunction rates compared with ERCP. Technical and clinical success, duration, adverse events and patency rates were similar.     

Clinical utility of treatment method conversion during single-session endoscopic ultrasound-guided biliary drainage

BACKGROUND Although several techniques for endoscopic ultrasound-guided biliary drainage(EUS-BD)are available at present,an optimal treatment algorithm of EUS-BD has not yet been established.AIM To evaluate the clinical utility of treatment method conversion during single endoscopic sessions for difficult cases in initially planned EUS-BD.METHODS This was a single-center retrospective analysis using a prospectively accumulated database.Patients with biliary obstruction undergoing EUS-BD between May 2008 and April 2016 were included.The primary outcome was to evaluate the improvement in EUS-BD success rates by converting the treatment methods during a single endoscopic session.Secondary outcomes were clarification of the factors leading to the conversion from the initial EUS-BD and the assessment of efficacy and safety of the conversion as judged by technical success,clinical success,and adverse events(AEs).RESULTS A total of 208 patients underwent EUS-BD during the study period.For 18.8%(39/208)of the patients,the treatment methods were converted to another EUSBD technique from the initial plan.Biliary obstruction was caused by pancreatobiliary malignancies,other malignant lesions,biliary stones,and other benign lesions in 22,11,4,and 2 patients,respectively.The reasons for the difficulty with the initial EUS-BD were classified into the following 3 procedures:Target puncture(n=13),guidewire manipulation(n=18),and puncture tract dilation(n=8).Technical success was achieved in 97.4%(38/39)of the cases and clinical success was achieved in 89.5%of patients(34/38).AEs occurred in 10.3%of patients,including bile leakage(n=2),bleeding(n=1),and cholecystitis(n=1).The puncture target and drainage technique were altered in subsequent EUSBD procedures in 25 and 14 patients,respectively.The final technical success rate with 95%CI for all 208 cases was 97.1%(95%CI:93.8%-98.9%),while that of the initially planned EUS-BD was 78.8%(95%CI:72.6%-84.2%).CONCLUSION Among multi-step procedures in EUS-BD,guidewire manipulation appeared to be the most technically challenging.When initially planned EUS-BD is technically difficult,treatment method conversion in a single endoscopic session may result in successful EUS-BD without leading to severe AEs.     

A comparison of uncovered metal stents for the palliation of patients with malignant biliary obstruction: nitinol vs. stainless steel

BackgroundVarious types of self-expandable metal stents have been introduced for the palliation of malignant biliary obstruction.AimsTo compare the outcomes of WallFlex™ and Wallstent™ uncovered biliary self-expandable metal stents (SEMSs) for the palliation of patients with malignant biliary obstruction.MethodsBetween October 2008 and December 2009, all SEMSs placed for malignant biliary obstruction were WallFlex™: all patients palliated were included in the study. Before October 2008, all the SEMSs placed for malignant biliary obstruction were Wallstent™, and the patients palliated from July 2007 to September 2008 were the comparative group.ResultsA total of 58 WallFlex™ and 54 Wallstent™ SEMSs were placed, and efficacious biliary decompression was achieved in all patients. Early complications occurred in 5 patients in the WallFlex™ group and in 3 in the Wallstent™ group (p = ns). Late complications occurred in 6 patients in the WallFlex™ group and in 16 in the Wallstent™ group (p < 0.01). The overall patency of the self-expandable metal stent in the WallFlex™ and the Wallstent™ groups was similar (227 days vs. 215 days, p = ns). Mean patient survival was 242 days in the WallFlex™ group and 257 days in the Wallstent™ group (p = ns).ConclusionsWe found no difference in terms of overall patency between the two types of SEMSs, but there was an increased rate of late adverse events in the Wallstent™ group.     

One-stage percutaneous triple procedure for treatment of endoscopically unmanageable patients with malignant biliary obstruction and marked ascites

Background and study aimsTo assess the feasibility, safety and efficacy of one-stage percutaneous triple procedure including; ascites drainage, primary metallic biliary stenting, and tract embolisation with N-butyl 2-cyanoacrylate (NBCA), in treatment of patients with malignant biliary obstruction and marked ascites.Patients and methodsThis study involved 25 patients with malignant biliary obstruction and marked ascites (age range, 46–78 y; mean age ± SD, 65 y ± 5) for whom endoscopic treatment failed or was unsuitable. Ascites drainage, percutaneous primary metallic biliary stenting, and tract embolisation with lipiodol/NBCA mixture were performed in a one-stage procedure. The mean ± SD follow up period was 26 ± 2 weeks.ResultsThe technical and clinical success rates were 96% and 88% respectively. No procedure related deaths or major complications were observed. The reported minor complications included; moderate pain and vomiting during and after balloon dilation, postprocedural cholangitis, and bile leakage in 44%, 16%, and 8% of the patients respectively. Primary stent patency was achieved in 96%. The 30-days mortality was 8%. The stent obstruction occurred in 3 (13%) of the 23 patients who survived more than 30-days.ConclusionsPercutaneous drainage of ascites followed immediately by primary biliary stenting, together with tract embolisation with NBCA is technically feasible, safe, and effective alternative palliative treatment for endoscopically unmanageable patients with malignant biliary obstruction and marked ascites.     

Acetylsalicylic acid for metal stent in malignant distal common bile duct obstruction: A randomized controlled trial

BackgroundEndoscopic biliary drainage is the treatment of choice for patients with malignant distal common bile duct obstruction. Self-expandable metal stents have clinical advantages including an increased duration of patency that may be prolonged by acetylsalicylic acid (ASA) use. The aim of this study was to investigate whether ASA had a positive effect on the patency of self-expandable metal stents compared with placebo.MethodsThis prospective, multicenter, double-blinded, and randomized placebo-controlled trial was conducted from October 2017 to May 2020 in Korea. Patients who underwent palliative endoscopic biliary drainage with self-expandable metal stents for malignant distal bile duct obstruction were enrolled, and allocated to ASA treatment or placebo. The study outcomes were the rate of stent dysfunction at 6 months, duration of stent patency, risk factors for stent dysfunction, and any adverse events.ResultsInterim analysis included 24 and 28 patients in the ASA and placebo groups, respectively. There was no significant difference between the ASA and placebo groups in stent dysfunction (25.0% vs. 20.7%, P = 0.761) or the duration of stent patency (150.97 ± 10.55 vs. 158.07 ± 8.70 days, P = 0.497). Six patients experienced suspected ASA-related adverse events, and there was one lethal case.ConclusionsASA did not prolong stent patency. This study was terminated early because of the possibility of serious adverse events related to ASA treatment of these patients receiving palliative care.