Bryan G. Sauer

Temporary placement of fully covered self-expandable metal stents in benign biliary strictures: midterm evaluation (with video)

BACKGROUND Benign biliary strictures (BBS) have been endoscopically managed with placement of multiple plastic stents. Uncovered metal stents have been associated with mucosal hyperplasia and partially covered self-expandable metal stents with migration. Recently, fully covered self-expandable metal stents (CSEMSs) with anchoring fins have become available. OBJECTIVE Our purpose was to analyze the efficacy and complication rates of CSEMSs in the treatment of BBS. DESIGN CSEMSs (10-mm diameter) were placed in 44 patients with BBS. CSEMSs were left in place until adequate biliary drainage was achieved, confirmed by resolution of symptoms, normalization of liver function tests, and imaging. SETTING Tertiary care center with long-standing experience with metal stents. PATIENTS A total of 44 patients with BBS (28 men, median age 53.5 years) were included. The preprocedure diagnoses included chronic pancreatitis (n = 19), gallstone-related strictures (n = 14), post liver transplant (n = 9), autoimmune pancreatitis (n = 1), and primary sclerosing cholangitis (n = 1). INTERVENTION ERCP with temporary CSEMS placement. Removal of CSEMSs was performed with a snare or rat tooth. MAIN OUTCOME MEASUREMENTS Stricture resolution and morbidity. RESULTS The median time of CSEMS placement was 3.3 months (interquartile range 3.0-4.8). Resolution of the BBS was confirmed in 34 of 41 patients (83%) after a median postremoval follow-up time of 3.8 months (interquartile range 1.2-7.7). Complications were observed in 6 (14%) patients after CSEMS placement and in 4 (9%) after CSEMS removal. LIMITATION Pilot study from a single center. CONCLUSION Temporary placement of CSEMSs for BBS may offer an alternative to plastic stenting. Further investigation is required to further assess safety and long-term efficacy.

Single-balloon enteroscopy effectively enables diagnostic and therapeutic retrograde cholangiography in patients with surgically altered anatomy

BACKGROUND In patients with surgically altered anatomy, ERCP is often unsuccessful. Single-balloon enteroscopy (SBE) enables deep intubation of the small bowel, permitting diagnostic and therapeutic ERCP in this subset of patients. OBJECTIVE To determine the effectiveness of SBE in performing endoscopic retrograde cholangiography (ERC) in patients with surgically altered anatomy. DESIGN Case series. SETTING Large quaternary-care center. PATIENTS Thirteen patients (11 women) underwent 16 SBE procedures with ERCP. Patient anatomy consisted of Whipple (n = 3), hepaticojejunostomy (n = 3), Billroth II (n = 1), and Roux-en-Y (n = 9). INTERVENTIONS Patients with surgically altered anatomy in whom standard ERCP techniques had failed or were not possible underwent ERC by using SBE with initial therapeutic intent. MAIN OUTCOME MEASUREMENTS Success rates of diagnostic ERC and therapeutic ERC in those patients who required biliary intervention. Procedure-related complications were also assessed. RESULTS Diagnostic ERC was successful 12 (92.3%) of 13 patients and in 13 (81.3%) of 16 cases. Therapeutic ERC was required in 10 patients in whom diagnostic ERC was first accomplished, and therapeutic ERC was successful in 9 (90%) of 10 patients. Biliary interventions included balloon dilation (n = 4), stone extraction (n = 2), sphincterotomy (n = 4), removal of a surgically placed stent (n = 3), and stenting (n = 2). Two patients developed pancreatitis after therapeutic ERC. Median follow-up was 53 days (range 22-522 days). Overall procedural success in an intent-to-treat analysis by case was 75%. LIMITATION Single-center experience. CONCLUSION SBE enables diagnostic and therapeutic ERC in most patients with altered anatomy. SBE-assisted therapeutic ERC may be associated with an increased risk of pancreatitis. Improvement of the available equipment is necessary to perform more efficient and effective biliary interventions.

Endoscopic Ultrasound-assisted Bile Duct Access and Drainage Multicenter, Long-term Analysis of Approach, Outcomes, and Complications of a Technique in Evolution

Background and Study Aims: When endoscopic retrograde cholangio-pancreatography fails, the bile duct is drained percutaneously or surgically. Evolution of endoscopic ultrasound (EUS) has provided the ability to visualize and also drain the biliary tree. The aim of this study was to review different techniques of EUS-guided bile duct access and drainage, and compare extrahepatic (EH) and intrahepatic (IH) approaches and benign with malignant indications. Patients and Methods: EUS-guided attempts at bile duct drainage from 6 international centers were reviewed. This is a multicenter, nonrandomized retrospective study. Results: Two hundred forty patients underwent EUS-guided bile duct access and drainage (EUS-BD) with a mean age of 67.3 years. The IH approach was used in 60% of the cases. In 99% of the subjects, a 19-G needle was used. Success was achieved in 87% cases, with a similar success rate in EH and IH approaches (84.3% vs. 90.4%; P=0.15). Metal stents were placed in 60% and plastic stents in 27% of the cases. A higher success rate was noted in malignant diseases compared with benign diseases (90.2% vs. 77.3%; P=0.02). Complications for all techniques included pneumoperitoneum 5%, bleeding 11%, bile leak/peritonitis 10%, and cholangitis 5%. No significant difference was noted between the IH and the EH approaches (32.6% vs. 35.6%; P=0.64), with similar rates in benign and malignant diseases (26.7% vs. 37.1%; P=0.19). Conclusions: The EUS-BD technique is currently limited by a lack of dedicated devices and large data reporting outcomes and complications. Larger prospective and multicenter studies are needed to better define the indications, outcomes, and complications. With greater experience and dedicated devices, EUS-BD can be an effective alternative.

Temporary placement of a fully covered self-expandable metal stent in the pancreatic duct for management of symptomatic refractory chronic pancreatitis: preliminary data (with videos)

BACKGROUND Pancreatic duct (PD) stenting is beneficial for the treatment of pain in patients with PD strictures associated with chronic pancreatitis. Placement of metal stents has been reported but failed secondary to hyperplasia or migration. OBJECTIVE To investigate the outcome of patients with symptomatic and refractory PD strictures who had temporary placement of a covered self-expandable metal stent (CSEMS). DESIGN Patients with refractory PD strictures were offered temporary CSEMS placement. Pain scores were evaluated before and after CSEMS placement. SETTING A tertiary-care center. PATIENTS Six patients (4 men, mean age +/- SD 55 +/- 8 years) received a CSEMS, and 5 patients had removal of a CSEMS after a mean time of 92 days. INTERVENTION Placement of CSEMS (8-mm or 10-mm diameter VIABIL) in the PD, with removal after 3 months. MAIN OUTCOME MEASUREMENTS The pain score before and after stent placement and the sustained response after removal. Morbidity associated with stent placement and removal was also noted. RESULTS Pain scores after CSEMS placement significantly improved (P = .024), from 6.4 to 1.6. Of the 5 patients who underwent CSEMS removal, 3 developed recurrent symptomatic pancreatic stricture, of whom 2 required repeat stenting with a larger-diameter CSEMS (10 mm) and 2 remained pain free. The CSEMS was not removed in 1 patient because pancreatic malignancy was diagnosed. There were no complications during placement or removal of CSEMSs. LIMITATION This was a pilot study. CONCLUSION Temporary placement of CSEMSs in patients with symptomatic refractory PD stricture offers transient relief of pain. Further investigation is needed to determine the optimal diameter and duration of placement.

Multicenter trial evaluating the use of covered self-expanding metal stents in benign biliary strictures: time to revisit our therapeutic options?

Background: Covered self-expanding metal stents are being used more frequently in benign biliary strictures (BBS). We report the results of a multicenter study with fully covered self-expanding metal stent (FCSEMS) placement for the management of BBS. Aim: To prospectively evaluate the efficacy and safety of FCSEMS in the management of BBS. Patients and Methods: Patients with BBS from 6 tertiary care centers who received FCSEMS with flared ends between April 2009 and October 2010 were included in this retrospective study. Efficacy was measured after removal of FCSEMS by evaluating stricture resolution on the basis of symptom resolution, imaging, laboratory studies, and/or choledochoscopy at removal. Safety profile was evaluated by assessing postprocedural complications. Results: A total of 133 patients (78, 58.6% males) with a mean age of 59.2±14.8 years with BBS received stents. Of the 133 stents placed, 97 (72.9%) were removed after a mean stent duration of 95.5±48.7 days. Stricture resolution after FCSEMS removal was as follows: postsurgical, 11/12 (91.6%); gallstone-related disease, 16/19 (84.2%); chronic pancreatitis, 26/31 (80.7%); other etiology, 4/5 (80.0%); and anastomotic strictures, 19/31(61.2%). Ninety-four patients were included in the logistic regression analyses. Patients who had indwelling stents for >90 days were 4.3 times more likely to have resolved strictures [odds ratio, 4.3 (95% confidence interval, 1.24-15.09)] and patients with nonmigrated stents were 5.4 times more likely to have resolved strictures [odds ratio, 5.4 (95% confidence interval, 1.001-29.29)]. Conclusions: FCSEMS for BBS had an acceptable rate of stricture resolution for postsurgical strictures, gallstone-related strictures, and those due to chronic pancreatitis. Predictors for stricture resolution include longer indwell time and absence of migration. Further study is warranted to assess long-term efficacy in a prospective manner with longer than 3-month time of stent indwelling time.

ERCP-directed radiofrequency ablation and photodynamic therapy are associated with comparable survival in the treatment of unresectable cholangiocarcinoma.

BACKGROUND Cholangiocarcinoma (CCA) is a malignancy with a poor 5-year survival rate (5%-10%). ERCP-directed radiofrequency ablation (RFA) or photodynamic therapy (PDT) can be performed as palliative therapy for unresectable CCA. ERCP with PDT is associated with improved survival compared with stent placement alone. However, ERCP-directed RFA has not been directly compared with PDT in patients with CCA. OBJECTIVE To compare overall survival in patients with unresectable CCA who underwent palliative ERCP-directed RFA versus PDT. DESIGN Retrospective cohort study. SETTING Tertiary-care academic medical center. PATIENTS Forty-eight patients with unresectable CCA who underwent ERCP-directed ablative therapy for palliation of unresectable CCA. INTERVENTIONS ERCP-directed RFA or PDT. MAIN OUTCOME MEASUREMENTS Overall survival by Kaplan-Meier analysis after initial treatment with either RFA or PDT. RESULTS Patients who underwent RFA (n = 16) demonstrated an overall survival similar to that of those who underwent PDT (n = 32), with a median survival of 9.6 versus 7.5 months, respectively (P = .799). Patient age (P = .45), sex (P = .52), and lead time (P = .59) from presentation to initial RFA or PDT had no significant association with survival. The presence of distant metastasis was inversely associated with survival (hazard ratio 3.55; 95% confidence interval, 1.29-9.77; P = .014). Patients who underwent RFA (compared with PDT) had a lower mean number of plastic stents placed per month (0.45 vs 1.10, P = .001) but also had more episodes of stent occlusion (0.06 vs 0.02, P = .008) and cholangitis (0.13 vs 0.05, P = .008) per month. LIMITATIONS Retrospective, single-center design. CONCLUSIONS Survival after ERCP-directed RFA and PDT was not statistically different in patients with unresectable CCA. A randomized, controlled trial is warranted to validate these preliminary results.

Multimodality endoscopic treatment of pancreatic duct disruption with stenting and pseudocyst drainage: How efficacious is it?

BACKGROUND Few studies have described the role of multimodality therapy and the complexity of endoscopic management of pancreatic duct disruption. Our study aim was to analyse and confirm factors associated with the resolution of pancreatic duct disruption. METHODS Over 6 years, retrospective data on patients with pancreatic duct disruption managed endoscopically were retrieved. Success was defined as resolution of the pancreatic duct disruption at 12 months. Logistic regression analysis was performed to determine factors associated with resolution. RESULTS 113 patients (78 male) with a mean age 51.3 year were included. Resolution of the pancreatic duct leak occurred in 80 cases (70.2%). 72 cases received transpapillary pancreatic duct stents, with 51 demonstrating resolution of pancreatic duct leak (71%) cystenterostomy was performed in 68 patients with 51 resolved (75%). In partial duct disruptions, pancreatic duct stenting combined with endoscopic drainage of fluid collections resulted in an increased rate of resolution (80%) compared to complete disruptions treated in a similar manner (57%). In complete pancreatic ductal disruptions, transpapillary pancreatic duct stenting had no additional benefit (9/17, 52.9%) compared to cystenterostomy or percutaneous drainage alone (24/34, 70.6%; P=0.61). CONCLUSION Pancreatic duct disruptions require multimodality treatment, addressing not only the integrity of the pancreatic duct but also any fluid collections associated. Partial ductal disruption should be managed by a bridging stent.

Holmium-yttrium aluminum garnet laser lithotripsy in the treatment of biliary calculi using single-operator cholangioscopy: a multicenter experience (with video)

13,14 Endoscopic retrograde cholangiography has been the criterion standard treatment of bile duct stones since 1974. Use of standard endoscopic techniques such as sphincterotomy, extraction balloon, basket, or mechanical lithotripsy have been successful in approximately 90% of these patients. Electrohydraulic (EHL) and laser lithotripsy were introduced in the mid-1980s as new treatment modalities for the 10% to 15% of patients with refractory stones and were found to be very effective. Because of the increased risk of heat-induced perforation, these techniques have been performed under either direct cholangioscopic visualization or fluoroscopically with a

Elevated stricture rate following the use of fully covered self-expandable metal biliary stents for biliary leaks following liver transplantation

BACKGROUND Biliary leaks and strictures are common complications after liver transplantation and can be managed surgically or endoscopically. Endoscopic management using fully covered self-expandable metal stents (FCSEMS) might provide some advantages over the commonly used plastic stents in the management of bile leaks after liver transplantation. METHODS Between December 2006 and January 2009, 17 liver transplant recipients underwent placement of a FCSEMS for treatment of biliary leaks. RESULTS FCSEMS were deployed at median of 18 days (range: 6 - 160) after liver transplantation and left in place for a median of 102 days (range: 35 - 427), with a median follow-up after FCSEMS removal of 407 days (range: 27 - 972). Long-term leak control was obtained in all but one patient. Complications included 6 clinically significant biliary strictures (35 %), which were treated with repeat stent placement, and two clinically insignificant strictures (12 %) which required no intervention. Additionally, three patients (18 %) had biliary ulcerations after stent removal, confirmed by choledochoscopy, and were managed conservatively. Two patients required repeat liver transplantation due to hepatic artery thrombosis, and one patient died from sepsis unrelated to FCSEMS stenting. CONCLUSIONS FCSEMS treat biliary leaks effectively, but carry a relatively high stricture risk in patients who have received liver transplants. FCSEMS cannot be recommended for management of biliary leaks following liver transplantation at this point.

Interobserver agreement for evaluation of imaging with single operator choledochoscopy: What are we looking at?

BACKGROUND Single operator choledochoscopy is a platform used to assist in the confirmation of diagnosis of biliary lesions. However, there are little data regarding the interobserver agreement of imaging interpretation. Our objective was to assess the interobserver agreement in single operator choledochoscopy interpretation. METHODS 38 De-identified SPY Choledochoscopy video clips were sent to 7 interventional endoscopists. They were asked to score the videos on presence of four criteria selected by the investigators: growth, stricture, hyperplasia, and ulceration. Observers also chose a final diagnosis from the categories of cancer, hyperplasia, inflammation, or normal. Kappa scores were calculated for the scoring of the four criteria and for the selection of the final diagnosis. RESULTS The overall interobserver agreement was fair in scoring for the presence of a growth (K=0.28, SE 0.035) and stricture (K=0.32, SE 0.035). Scoring for ulceration was slight to fair (K=0.17, SE 0.035). There was only slight agreement for the presence of hyperplasia (K=0.11, SE 0.035); and presumed final diagnosis based on imaging (K=0.18, SE 0.022). CONCLUSION The results of this study support the need for an effort to identify and validate cholangioscopy imaging criteria for biliary pathology. This may assist in improving the reliability of the diagnostic value of cholangioscopy as its use becomes more widespread.