International consensus statements for endoscopic management of distal biliary stricture.

Distal biliary strictures (DBS) are common and may be caused by both malignant and benign pathologies. While endoscopic procedures play a major role in their management, a comprehensive review of the subject is still lacking. Our consensus statements were formulated by a group of expert Asian pancreatico-biliary interventional endoscopists, following a proposal from the Digestive Endoscopy Society of Taiwan, the Thai Association for Gastrointestinal Endoscopy, and the Tokyo Conference of Asian Pancreato-biliary Interventional Endoscopy. Based on a literature review utilizing Medline, Cochrane library, and Embase databases, a total of 19 consensus statements on DBS were made on diagnosis, endoscopic drainage, benign biliary stricture, malignant biliary stricture, and management of recurrent biliary obstruction and other complications. Our consensus statements provide comprehensive guidance for the endoscopic management of DBS.

Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis by Endoscopic Pancreatic Stenting after Insertion of Self-Expandable Metal Stent for Malignant Distal Biliary Stricture.

The insertion of a self-expandable metal stent (SEMS) for nonpancreatic cancer is a factor predicting the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). We evaluated the efficacy of endo-scopic pancreatic stenting (EPS) to prevent PEP after SEMS insertion in patients with malignant distal biliary stricture and without main pancreatic duct (MPD) obstruction. We performed a single-center, retrospective, historically controlled investigation to assess the outcomes of 33 consecutive patients who underwent SEMS insertion. From March 2013 to June 2015, 13 patients did not undergo EPS (Non-EPS group). The other 20 patients underwent EPS (EPS group) between July 2015 and August 2018. The background data demonstrated no significant differences. Except for one patient in the Non-EPS group, all patients underwent biliary sphinc-terotomy. The EPS group's PEP incidence was significantly lower (n = 1, 5%) than that of the Non-EPS group (n = 4, 31%) (p = 0.04). The median serum amylase and lipase levels after the procedure were significantly lower in the EPS group than in the Non-EPS group (amylase: 104 vs. 262 U/L; p < 0.01, lipase: 102 vs. 666 U/L; p = 0.01). The use of EPS decreased the incidence of PEP after SEMS insertion in individuals with malignant distal biliary stricture and without MPD obstruction.

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.

Are self-expandable metal stents superior to plastic stents in palliating malignant distal biliary strictures? A meta-analysis and systematic review.

BACKGROUND: Palliation for inoperable malignant distal biliary strictures can be achieved with self-expandable metal stents (SEMS) and plastic stents (PS). This is a meta-analysis to compare PS and SEMS. The aim of the study is to compare clinical outcomes in patients with SEMS and PS. METHODS: Study selection criteria were studied using SEMS and PS for palliation in patients with malignant distal biliary stricture. For data collection and extraction, articles were searched in Ovid journals, Medline, Cochrane database, and Pubmed. Pooled proportions were calculated using both Mantel-Haenszel method and DerSimonian Laird method for statistical analysis. RESULTS: Initial search identified 1376 reference articles, of which 112 were selected and11 studies (N = 947) were included in this analysis. Pooled analysis showed SEMS patency to be 167.7days (95% CI = 159.2-176.3) compared to 73.3days (95% CI = 69.8-76.9) in PS. SEMS have lower odds of occlusion when compared to PS with an odds ratio of 0.48 (95% CI = 0.34-0.67). SEMS has a lower odds of cholangitis compared to SP, with an odds ratio of 0.46 (95% CI = 0.30-0.69). CONCLUSION: SEMS seem to be superior to PS with better patency periods and survival duration. SEMS have lower occlusion rates, re-intervention rates, and cholangitis.

No benefit of endoscopic sphincterotomy before biliary placement of self-expandable metal stents for unresectable pancreatic cancer.

BACKGROUND & AIMS: Endoscopic sphincterotomy (ES) is performed routinely before self-expandable metallic stents (SEMS) are placed in malignant distal biliary strictures to prevent postprocedural pancreatitis. However, it is not clear whether ES actually prevents pancreatitis or affects other adverse events (AEs). We conducted a noninferiority trial to examine the necessity of ES before SEMS placement. METHODS: Two hundred patients with distal biliary strictures caused by unresectable pancreatic cancer were assigned randomly to groups that received ES or did not receive ES (non-ES) before SEMS placement, at 25 hospitals in Hokkaido, Japan, from August 2010 through November 2012. The primary outcome was early AEs (≤30 d) specifically related to the presence or absence of ES (pancreatitis, bleeding, or perforation). Secondary outcomes measured included the effect of ES omission on time to SEMS dysfunction and patient survival times. RESULTS: The proportions of patients with early AEs were 9.2% in the non-ES group and 10.4% in the ES group (a difference of 1.2%, noninferior). The median times to SEMS dysfunction was longer than 594 days in the non-ES group and 541 days in the ES group (P = .88). The median overall survival times were 202 in the ES group vs 255 days in the non-ES group; P = .20). CONCLUSIONS: ES before SEMS does not affect the incidence of AEs, SEMS patency, or patient survival times. Our data provide no evidence for a benefit of ES to patients undergoing SEMS placement for a biliary stricture caused by pancreatic cancer. UMIN clinical trials registry number: 000004044.

Efficacy and safety of covered versus uncovered self­expandable metal stents for the palliative treatment of malignant distal biliary stricture: A long­term retrospective study.

Both covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (USEMSs) have been tried in the palliation of malignant distal biliary strictures by means of endoscopic retrograde cholangiopancreatography (ERCP); however, the comparison of efficacy and safety between them remains contested. To the best of our knowledge, no similar studies have assessed this in the Chinese population. In the present study, the clinical and endoscopic data of 238 patients (CSEMSs, n=55; USEMSs, n=183) with malignant distal biliary strictures from 2014 to 2019 were collected. The efficacy indicated by mean stent patency, stent patency rate, mean patient survival time and survival rate, and the safety indicated by adverse events after CSEMS or USEMS placement were retrospectively analyzed and compared. The mean stent patency time was significantly longer in the CSEMSs group than that in the USEMSs group (262.8±195.3 days vs. 169.5±155.7 days, P=0.002). The mean patient survival time was significantly longer in the CSEMSs group than that in the USEMSs group (273.9±197.6 days vs. 184.9±167.6 days, P=0.003). The stent patency rate and patient survival rate were significantly higher in the CSEMSs group than those in the USEMSs group at 6 and 12 months, but not at 1 and 3 months. There was no significant difference in stent dysfunction and adverse events between the two groups, although post-ERCP pancreatitis (PEP) occurred more frequently in the CSEMSs group than in the USEMSs group (18.1% vs. 8.8%, P=0.049). In conclusion, CSEMSs were better than USEMSs for malignant distal biliary strictures in terms of stent patency time and patient survival time as well as stent patency rate and patient survival rate in the long term (>6 months). Adverse events in the two groups occurred at a similar rate, although the incidence of PEP was higher in the CSEMSs group.

Early Diagnosis And Management Of Malignant Distal Biliary Obstruction: A Review On Current Recommendations And Guidelines.

Malignant biliary obstruction is a challenging condition, requiring a multimodal approach for both diagnosis and treatment. Pancreatic adenocarcinoma and cholangiocarcinoma are the leading causes of malignant distal biliary obstruction. Early diagnosis is difficult to establish as biliary obstruction can be the first presentation of the underlying disease, which can already be at an advanced stage. Consequently, the majority of patients (70%) with malignant distal biliary obstruction are unresectable at the time of diagnosis. The association of clinical findings, laboratory tests, imaging, and endoscopic modalities may help in identifying the underlying cause. Novel endoscopic techniques such as cholangioscopy, intraductal ultrasonography, or confocal laser endomicroscopy have been developed with promising results, but are not used in routine clinical practice. As the number of patients with malignant distal biliary obstruction who will undergo curative surgery is limited, endoscopy has a crucial role in palliation, to relieve biliary obstruction. According to the last European guidelines published in the management of biliary obstruction, self-expandable metal stents have a central place in biliary drainage compared to plastic stents. Endoscopic ultrasound has evolved impressively in the last decades. When standard techniques of biliary cannulation by endoscopic retrograde cholangiopancreatography fail, endoscopic ultrasound-guided biliary drainage is a good option compared to percutaneous drainage.

Simple Clinical Score to Predict 24-Week Survival Times in Patients with Inoperable Malignant Distal Biliary Obstruction as a Tool for Selecting Palliative Metallic or Plastic Stents.

BACKGROUND AND AIM: Endoscopic biliary drainage (EBD) is the mainstay treatment for inoperable malignant distal biliary obstruction (MDBO). Some authorities suggest that metallic stents are more cost-effective than plastic stents in patients with expected survival of at least 6 months. However, studies attempting to define the predictive factors for such survival times are limited. This study aims to develop a scoring system for predicting a survival time of <24 weeks in these patients. METHOD: Patients with MDBO from inoperable periampullary cancers who underwent EBD at Songklanagarind Hospital during 2004-2009 were retrospectively analyzed. Baseline clinical, laboratory, and imaging data were retrieved. The survival time data were retrieved from the medical records and Thailand's civil registration database. Multivariate Cox regression model coefficients were used in the development of a survival time prediction scoring system. RESULTS: Ninety-eight patients were included. The overall median survival was 17.6 weeks. Fifty-seven (58.1%) survived <24 weeks. By multivariate analysis, cancer type and liver metastasis were significant predictive factors. The Simple Clinical Score (SCS) was calculated from (2× liver metastasis) + (1× pancreatic cancer) - (2× ampullary cancer) - (1× cholangiocarcinoma), when 1 and 0 were used for the presence and absence of each factor, respectively. The cutoff value of the score ≥0 had a sensitivity and specificity of 0.77 and 0.63, respectively, for predicting a survival time of <24 weeks, with AUC of 0.76. The median survival of patients with SCS <0 and ≥0 was 36.6 and 13.1 weeks, respectively. CONCLUSION: The scoring system from this study may be beneficial for clinicians to select the appropriate stents in endoscopic biliary drainage in inoperable MDBO patients.