Michel Kahaleh

Temporary placement of covered self-expandable metal stents in benign biliary strictures: a new paradigm? (with video)

BACKGROUND Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. OBJECTIVE We analyzed the efficacy and safety of temporary placement of a covered self-expanding metal stent (CSEMS) in BBS. DESIGN Patients with BBS received temporary placement of CSEMSs until adequate drainage was achieved; confirmed by resolution of symptoms, normalization of liver function tests, and imaging. SETTING Tertiary-care center with long-standing experience with CSEMSs. PATIENTS Seventy-nine patients with BBS secondary to chronic pancreatitis (32), calculi (24), liver transplant (16), postoperative biliary repair (3), autoimmune pancreatitis (3), and primary sclerosing cholangitis (1). INTERVENTION ERCP with temporary CSEMS placement. Removal of CSEMSs was performed with a snare or a rat-tooth forceps. MAIN OUTCOME MEASUREMENTS End points were efficacy, morbidity, and clinical response. RESULTS CSEMSs were removed from 65 patients. Resolution of the BBS was confirmed in 59 of 65 patients (90%) after a median follow-up of 12 months after removal (range 3-26 months). If patients who were lost to follow-up, developed cancer, or expired were considered failures, then an intent-to-treat global success rate of 59 of 79 (75%) was obtained. Complications associated with placement included 3 post-ERCP pancreatitis (4%), 1 postsphincterotomy bleed (1%), and 2 pain that required CSEMS removal (2%). In 11 patients (14%), the CSEMS migrated. In 1 patient, CSEMS removal was complicated by a bile leak that was successfully managed with plastic stents. LIMITATION Pilot study from a single center. CONCLUSIONS Temporary CSEMS placement in patients with BBS offers a potential alternative to surgery.

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.

Efficacy and complications of covered wallstents in malignant distal biliary obstruction

BACKGROUND This study evaluated the efficacy and the complications associated with the use of the covered Wallstent in the setting of unresectable malignant biliary obstruction. METHODS Between March 2001 and January 2003, all patients with distal malignant biliary obstruction that required drainage were treated with a covered Wallstent. Every 2 months, the patients were evaluated clinically and biochemical tests of liver function were obtained. Data were recorded for the following variables: early complications (within 30 days of stent placement), early and late stent occlusion, duration of stent patency, need for subsequent biliary intervention, and patient survival. RESULTS A total of 88 covered Wallstents were inserted in 80 patients. Stent patency rates at 3, 6, and 12 months were 90%, 82%, and 78%, respectively. Complications included stent migration (5), stent occlusion (12), episodes of cholecystitis (3), and episodes of post-ERCP pancreatitis (5). Biliary intervention was required in 9 patients subsequent to placement of the initial covered Wallstent. CONCLUSIONS Deployment of a covered Wallstent is safe and relatively easy. It achieves biliary drainage with an acceptable risk to benefit ratio in the majority of patients with distal malignant biliary obstruction.

Transenteric drainage of pancreatic-fluid collections with fully covered self-expanding metallic stents (with video)

BACKGROUND Drainage of pancreatic-fluid collections (PFCs) by using fully covered self-expanding metallic stents (CSEMSs) offers the option of providing a larger-diameter access fistula for drainage when compared with plastic stents. OBJECTIVE To evaluate the efficacy and safety of transenteric drainage of PFCs by using CSEMSs. DESIGN A prospective case series. SETTING A tertiary-referral center. PATIENTS Between January 2007 and September 2007, 18 patients underwent drainage of PFCs by using CSEMSs. Follow-up and final results were prospectively recorded until May 2008. INTERVENTIONS Placement of CSEMSs with a double-pigtail stent placed alongside (4 cases) or into the CSEMS (14 cases) to prevent migration. MAIN OUTCOME MEASUREMENTS The number of sessions and time to resolution of the PFCs. RESULTS A median of 1 session was required to achieve drainage (range 1-4) when using CSEMSs. Complications included superinfection (5), bleeding (2), and inner migration (1). A total of 17 of 18 patients (95%) responded successfully, with 14 patients (78%) achieving complete resolution of their PFC. The mean (+/- SD) time of follow-up until final resolution was 77 +/- 80 days (range 15-310 days). CONCLUSIONS Placement of CSEMSs seems to offer an effective and safe alternative for the drainage of PFCs. A randomized controlled trial should be performed to compare this technique with plastic-stent drainage.

Unresectable Cholangiocarcinoma: Comparison of Survival in Biliary Stenting Alone Versus Stenting With Photodynamic Therapy

BACKGROUND & AIMS Photodynamic therapy (PDT) for unresectable cholangiocarcinoma is associated with improvement in cholestasis, quality of life, and potentially survival. We compared survival in patients with unresectable cholangiocarcinoma undergoing endoscopic retrograde cholangiopancreatography (ERCP) with PDT and stent placement with a group undergoing ERCP with stent placement alone. METHODS Forty-eight patients were palliated for unresectable cholangiocarcinoma during a 5-year period. Nineteen were treated with PDT and stents; 29 patients treated with biliary stents alone served as a control group. Multivariate analysis was performed by using Model for End-Stage Liver Disease score, age, treatment by chemotherapy or radiation, and number of ERCP procedures and PDT sessions to detect predictors of survival. RESULTS Kaplan-Meier analysis demonstrated improved survival in the PDT group compared with the stent only group (16.2 vs 7.4 months, P<.004). Mortality in the PDT group at 3, 6, and 12 months was 0%, 16%, and 56%, respectively. The corresponding mortality in the stent group was 28%, 52%, and 82%, respectively. The difference between the 2 groups was significant at 3 months and 6 months but not at 12 months. Only the number of ERCP procedures and number of PDT sessions were significant on multivariate analysis. Adverse events specific to PDT included 3 patients with skin phototoxicity requiring topical therapy only. CONCLUSIONS ERCP with PDT seems to increase survival in patients with unresectable cholangiocarcinoma when compared with ERCP alone. It remains to be proved whether this effect is attributable to PDT or the number of ERCP sessions. A prospective randomized multicenter study is required to confirm these data.

Safety and efficacy of ERCP in pregnancy

BACKGROUND Choledocholithiasis during pregnancy increases the risk of morbidity and mortality for both fetus and mother because of cholangitis and pancreatitis. ERCP has been advocated as safe and effective in pregnant women, but fetal radiation exposure is not routinely monitored. The aim of this study was to record fetal exposure to ionizing radiation during ERCP and to assess outcome. METHODS Seventeen ERCPs were performed in pregnant women between January 1995 and August 2003. Techniques to minimize fluoroscopy were used, and fluoroscopy times were recorded. Thermoluminescent dosimeters affixed to the skin of the mother were used to estimate fetal radiation exposure. OBSERVATIONS Mean gestational age was 18.6 (8.9) weeks (range 5-33 weeks). Mean fluoroscopy time was 14 (13) seconds (range 1-48 seconds). Estimated fetal radiation exposure was 40 (46) mrad (range 1-180 mrad). There was a correlation between fluoroscopy time and radiation exposure, but there was a wide range of radiation exposure for individual fluoroscopy times. Complications included post-sphincterotomy bleeding in one patient (controlled by hemoclip placement) and post-ERCP pancreatitis in one patient that necessitated 3 days of hospitalization. Two women developed third-trimester preeclampsia, and labor was induced in both. Thirteen of the 15 patients who delivered were contacted and they confirmed that their child was in good health. CONCLUSIONS ERCP with modified techniques is safe during pregnancy. Dosimetry should be routinely recorded.

Interventional endoscopic ultrasound-guided cholangiography: long-term experience of an emerging alternative to percutaneous transhepatic cholangiography.

BACKGROUND AND STUDY AIMS Endoscopic retrograde cholangiography (ERC) with stenting is the procedure of choice for biliary decompression in patients with obstructive jaundice. In cases where biliary access cannot be achieved, interventional endoscopic ultrasound-guided cholangiography (IEUC) has become an alternative to percutaneous transhepatic cholangiography (PTC). PATIENTS AND METHODS We report on 5 years of experience in patients who underwent IEUC after failed endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic ultrasound-guided access to the targeted biliary duct was attempted with one of two approaches: transgastric-transhepatic (intrahepatic) or transenteric-transcholedochal (extrahepatic). A stent was then advanced over the wire and into the biliary tree. RESULTS A total of 49 patients underwent IEUC: 35 had biliary obstruction due to malignancy and 14 had a benign etiology. The overall success rate of IEUC was 84% (41/49), with an overall complication rate of 16%. Of the 35 patients who underwent the intrahepatic approach, 23 had a stent placed across the major papilla, one had a stent placed intraductally in the common bile duct, and three patients underwent placement of a gastrohepatic stent. Resolution of obstruction was achieved in 29 patients, with a success rate of 83%. In all, 14 patients underwent an extrahepatic approach. In 8/14 (57%), stent placement across the major papilla was achieved. A transenteric stent was placed in four patients. Biliary decompression was achieved in 12/14 cases (86%). Based on intention-to-treat analysis, the intrahepatic approach achieved success in 29 of 40 cases (73%), and the extrahepatic approach was successful in seven of nine cases (78%). There were no procedure-related deaths. CONCLUSION IEUC offers a feasible alternative to PTC in patients with obstructive jaundice in whom ERC has failed.

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.

Interventional EUS cholangiography: a report of five cases

BACKGROUND ERCP may be unsuccessful because of the presence of a complex peripapillary diverticulum, prior surgery, obstructing tumor, papillary stenosis, or impacted stones. Percutaneous transhepatic cholangiography is a classic technique for accessing the bile duct and remains the primary alternative when biliary ERCP is unsuccessful. With the evolution of interventional EUS, additional options are available for management of biliary obstruction. METHODS EUS cholangiography was performed, after which the puncture was enlarged to form an enterocholedochal fistula that was used for interventions that resulted in biliary decompression in 5 patients with obstructive jaundice. OBSERVATIONS Cholangiography was readily performed in all 5 patients. In one patient, a guidewire could not be manipulated across the papilla via the enterocholedochal fistula, necessitating percutaneous intervention. Biliary decompression was achieved in the other 4 patients, in the last two, as a single procedure. CONCLUSIONS Interventional EUS cholangiography is a new technique that allows drainage of a dilated biliary system when the bile duct is inaccessible by conventional ERCP.

Partially covered self-expandable metallic stents for benign biliary strictures due to chronic pancreatitis

BACKGROUND AND STUDY AIMS Benign biliary strictures (BBS) may occur in patients with chronic pancreatitis and may lead to secondary biliary cirrhosis or recurrent cholangitis. Although surgical diversion may provide definitive therapy, it can be associated with significant morbidity. Endoscopic therapy with plastic stents has been used as an alternative to surgery but has resulted in unsatisfactory long-term outcomes. We evaluated the temporary placement of partially covered self-expandable metallic stents (PCMS) in patients with BBS due to chronic pancreatitis. PATIENTS AND METHODS A total of 20 patients with BBS due to chronic pancreatitis underwent temporary placement of PCMS over a 6-year period. The primary outcome of interest was the proportion of patients with stricture resolution persisting 6 months after stent removal. Secondary outcomes included the stent failure rate, number of endoscopic sessions required to achieve biliary drainage, total duration of stenting, and complication rate. RESULTS Adequate biliary drainage was achieved in 19 patients with PCMS (95%). Eighteen of the 20 patients (90%) had persistent stricture resolution 6 months after PCMS removal. In two of the 20 patients (10%), PCMS stenting failed and these patients underwent alternative therapies. Complications occurred in four patients (20%). Median duration of PCMS placement was 5 months, requiring a median of two endoscopic procedures. CONCLUSION In this series of patients with BBS due to chronic pancreatitis, temporary PCMS placement achieved persistent stricture resolution in the majority of patients with acceptable complication rates. Comparative trials evaluating temporary PCMS placement and plastic stenting in patients with BBS due to chronic pancreatitis are needed.