The morphological and histopathological assessment of Alagille syndrome with extrahepatic bile duct obstruction: the importance of the differential diagnosis with subgroup "o" biliary atresia.

PURPOSE: The differential diagnosis between Alagille syndrome (AGS) with extrahepatic bile duct obstruction (EHBDO) and biliary atresia (BA) is difficult. We report a case series of AGS with EHBDO with detailed validation of the morphological and histopathological features for the differential diagnosis of BA. METHODS: Six liver transplantations (LTs) were performed for AGS with EHBDO. All patients were diagnosed with BA at the referring institution and the diagnosis of AGS was then confirmed based on a genetic analysis before LT. We verified the morphological and histopathological findings of the porta hepatis and liver at the diagnosis of BA and at LT. RESULTS: All patients had acholic stool in the neonatal period and were diagnosed with BA by cholangiography. The gross liver findings included a smooth and soft surface, without any cirrhosis. The gross findings of the porta hepatis included aplasia of the proximal hepatic duct, or subgroup "o", in five patients. The histopathological examination of the EHBD also revealed obstruction/absence of the hepatic duct. There were no patients with aplasia of the common bile duct. CONCLUSIONS: Aplasia of the hepatic duct and the macroscopic liver findings may help in to differentiate between AGS with EHBDO and BA.

New antireflux plastic stent for patients with distal malignant biliary obstruction.

BACKGROUND: Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction (MBO). However, the main problem with stent placement is the relatively short duration of stent patency. Although self-expanding metal stents (SEMSs) have a longer patency period than plastic stents (PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS (ARPS) has been proposed. We developed a new ARPS with a "duckbilled" valve attached to the duodenal end of the stent. AIM: To compare the patency of ARPSs with that of traditional PSs (TPSs) in patients with unresectable distal MBO. METHODS: We conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success, adverse events, and patient survival. RESULTS: Between February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events (P = 0.660, 1.000, and 1.000, respectively). The median duration of stent patency in the ARPS group was 285 d [interquartile range (IQR), 170], which was significantly longer than that in the TPS group (median, 130 d; IQR, 90, P = 0.005). No significant difference in patient survival was noted between the two groups (P = 0.900). CONCLUSION: The new ARPS is safe and effective for the palliation of unresectable distal MBO, and has a significantly longer stent patency than a TPS.

Cost Efficacy of Metal Stents for Palliation of Extrahepatic Bile Duct Obstruction in a Randomized Controlled Trial.

BACKGROUND & AIMS: Endoscopic stents are placed for palliation of extrahepatic bile duct obstruction. Although self-expandable metal stents (SEMS) remain patent longer than plastic stents, they are more expensive. We aimed to evaluate which type of stent (plastic, uncovered SEMS [uSEMS], or partially covered SEMS [pcSEMS]) is the most effective and we assessed costs. METHODS: We performed a multicenter randomized trial in 219 patients at 18 hospitals in The Netherlands from February 2008 through February 2013. Patients were assigned randomly for placement of a plastic stent (n = 73), uSEMS (n = 75), or pcSEMS (n = 71) during endoscopic retrograde cholangiopancreatography. Patients were followed up for up to 1 year. Researchers were not blinded to groups. The main study end points included functional stent time and costs. RESULTS: The mean functional stent times were 172 days for plastic stents, 288 days for uSEMS, and 299 days for pcSEMS (P < .005 for uSEMS and pcSEMS vs plastic). The initial placement of plastic stents (€1042 or $1106) cost significantly less than placement of SEMS (€1973 or $2094) (P = .001). However, the total cost per patient at the end of the follow-up period did not differ significantly between plastic stents (€7320 or $7770) and SEMS (€6932 or $7356) (P = .61). Furthermore, in patients with short survival times (≤3 mo) or metastatic disease, the total cost per patient did not differ between plastic stents and SEMS. No differences in costs were found between pcSEMS and uSEMS. CONCLUSIONS: Although placement of SEMS (uncovered or partially covered) for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents, SEMS have longer functional time. The total costs after 1 year do not differ significantly with stent type. Dutch Clinical Trial Registration no: NTR1361.

Predictive value of assessment of different modalities in the diagnosis of infantile cholestasis.

This study investigated the relative accuracy and roles of abdominal ultrasonography, hepatobiliary scintigraphy and liver biopsy in the diagnosis of infantile cholestasis. A total of 50 infants (27 females) aged 1 - 12 months were classified into those with intrahepatic causes of cholestasis (n = 22) and those with extrahepatic causes (n = 28). Cholestasis is caused by a wide range of conditions and diagnosis requires meticulous history taking, thorough clinical examination and many laboratory tests. The most common cause of intrahepatic cholestasis was found to be idiopathic neonatal hepatitis (54.5%), followed by infectious hepatitis (9.1%), metabolic liver diseases (9.1%), intrahepatic biliary atresia (9.1%) and Alagille syndrome (4.5%). The most common cause of extrahepatic cholestasis was extrahepatic biliary atresia (96.4%). The incidence of choledochal cyst was low (3.6%). The cornerstone of the diagnosis of infantile cholestasis was found to be liver biopsy, which was associated with a high degree of accuracy.

Autoimmune pancreatitis: disease evolution, staging, response assessment, and CT features that predict response to corticosteroid therapy.

PURPOSE: To evaluate the evolution of morphologic features of autoimmune pancreatitis (AIP) at computed tomography (CT) and to identify imaging features that can predict AIP response to corticosteroid therapy (CST). MATERIALS AND METHODS: This HIPAA-compliant retrospective study had institutional review board approval. From among a cohort of 63 patients with AIP, 15 patients (12 men, three women; mean age, 64.7 years; age range, 30-84 years) who underwent sequential CT examinations before treatment were included to assess the evolution of disease by reviewing pancreatic, peripancreatic, and ductal changes. Of these patients, 13 received CST and underwent posttreatment CT; these CT studies were evaluated to determine if there were imaging features that could predict response to CST. RESULTS: The disease evolved from changes of diffuse (14 of 15 patients) or focal (one of 15 patients) parenchymal swelling, peripancreatic stranding (10 of 15 patients), "halo" (nine of 15 patients), pancreatic duct changes (15 of 15 patients), and distal common bile duct narrowing (12 of 15 patients) to either resolution or development of ductal strictures and/or focal masslike swelling. In 13 patients treated with CST, favorable response to treatment was seen in those with diffuse pancreatic and peripancreatic changes. Suboptimal response was seen in patients with ductal stricture formation (two of 13 patients) and in those in whom focal masslike swellings persisted after resolution of diffuse changes (seven of 13 patients). CONCLUSION: CT features like diffuse swelling and halo respond favorably to CST and likely reflect an early inflammatory phase, whereas features like ductal strictures and focal masslike swelling are predictive of a suboptimal response and symbolize a late stage with predominance of fibrosis.

Comparison of accessory performance using a novel ERCP mechanical simulator.

BACKGROUND AND STUDY AIMS: There is a paucity of in vitro methods for evaluating ERCP accessories. We hypothesize that the time taken to perform a simulated single stent or multiple stents placement is different for stenting systems with or without the capability of intraductal ductal release (IDR) of the guide wire. PATIENTS AND METHODS: We conducted an un-blinded in vitro comparison of ERCP accessories using a mechanical simulator during hands-on ERCP practice workshops. A total of 21 U.S. participants and 20 Chinese participants with various level of ERCP experience took part in the different practice workshops. Accessories with and without the capability of intraductal release of guide wire were compared. Total time required for completing a simulated stenting procedure with single or multiple stents and the respective simulated fluoroscopy time were recorded. RESULTS: There was no significant difference in the time taken for placement of a single stent using either stenting systems. Stenting system capable of intraductal release of the guide wire required significantly shorter time to complete placement of three stents. CONCLUSIONS: Using time required to complete a specific task, i. e. biliary stenting, the mechanical simulator permits the performance of different accessories by the same group of operators to be evaluated objectively.

Intraductal US in the assessment of tumor involvement to the orifice of the cystic duct by malignant biliary obstruction.

BACKGROUND: Tumor involvement to the orifice of the cystic duct (OCD) is a risk factor for cholecystitis after metallic stent (MS) placement. OBJECTIVE: ERCP and intraductal US (IDUS) were used to assess tumor involvement to the OCD. DESIGN: A prospective consecutive study. SETTING: The University of Tokyo Hospital, Japan. PATIENTS AND INTERVENTIONS: Between January 2003 and May 2007, 34 patients with resectable malignant biliary obstruction underwent an ERCP and an IDUS before preoperative biliary drainage. MAIN OUTCOME MEASUREMENTS: ERCP and IDUS findings were confirmed via a histopathologic analysis of surgical specimens. RESULTS: An ERCP showed that the cystic duct was opacified in 22 of 34 patients (64.7%). Eight patients were diagnosed with OCD tumor involvement. In the remaining 12 patients, tumor involvement was impossible to evaluate via an ERCP. An IDUS identified tumor involvement to the OCD in all 34 patients. Tumor involvement to the OCD was diagnosed in 12 patients, including 4 patients with previously negative results during an ERCP. Tumor involvement was confirmed by histopathology of surgical specimens. The sensitivity and specificity of detection were 66.7% (8/12) and 63.6% (14/22), respectively, via ERCP, and 100% (12/12) and 100% (22/22), respectively, via IDUS. LIMITATION: The small sample size. CONCLUSIONS: IDUS, in addition to ERCP, provides an accurate evaluation of tumor involvement to the OCD in patients with malignant biliary obstruction.

Tannenbaum and metal stents in the palliative treatment of malignant distal bile duct obstruction: a comparative study of patency and cost effectiveness.

BACKGROUND: Stent clogging is the major limitation of palliative treatment for malignant biliary obstruction. Metal stents have much better patency than plastic stents, but are more expensive. Preliminary data suggest that the recently designed plastic (Tannenbaum) stent has better duration of patency than the polyethylene stent. This study aimed to compare the efficacy and cost effectiveness between the Tannenbaum stent without side holes and the uncovered metal stent for patients with malignant distal common bile duct obstruction. METHODS: In this study, 47 patients (median age, 73 years, range, 56-86 years) with inoperable malignant distal common bile duct strictures were prospectively randomized to receive either a Tannenbaum stent (n = 24) or an uncovered self-expandable metal stent (n = 23). The patients were clinically evaluated, and biochemical tests were analyzed if necessary until their death or surgery for gastric outlet obstruction. Cumulative first stent patency and patient survival were compared between the two groups. Cost-effectiveness analysis also was performed for the two study groups. RESULTS: The two groups were comparable in terms of age, gender, and diagnosis. The median first stent patency was longer in the metal group than in the Tannenbaum stent group (255 vs 123.5 days; p = 0.002). There was no significant difference in survival between the two groups. The total cost associated with the Tannenbaum stents was lower than for the metal stents (17,700 vs 30,100 euros; p = 0.001), especially for patients with liver metastases (3,000 vs 6,900 euros; p < 0.001). CONCLUSIONS: Metal stent placement is an effective treatment for inoperable malignant distal common bile duct obstruction, but Tannenbaum stent placement is a cost-saving strategy, as compared with metal stent placement, especially for patients with liver metastases and expected short survival time.

Magnetic resonance cholangiopancreatography in cholestatic diseases.

BACKGROUND/AIMS: To evaluate the usefulness of magnetic resonance cholangiopancreatography in cholestasis. METHODOLOGY: Sixty-seven patients with cholestasis underwent ultrasound and magnetic resonance cholangiopancreatography, subsequently. The results of ultrasound and magnetic resonance cholangiopancreatography were interpreted by two independent radiologists. RESULTS: According to ultrasonographic findings intra- and extrahepatic cholestasis were diagnosed in 62.7% and 37.3% of patients, respectively. Magnetic resonance cholangiopancreatography revealed intra- and extrahepatic cholestasis in 52.2% and 47.8% of patients at the same group, respectively (p=0.016, kappa=0.789). Endoscopic retrograde cholangiopancreatography was indicated in 37.3% of patients (22.4% diagnostic, 14.9% therapeutic) according to ultrasonographic findings. However, 41.8% of patients had indication for endoscopic retrograde cholangiopancreatography following magnetic resonance cholangiopancreatography in the same group. In 20% of patients who needed diagnostic endoscopic retrograde cholangiopancreatography according to ultrasonographic findings, endoscopic retrograde cholangiopancreatography wasn't indicated after magnetic resonance cholangiopancreatography. Similarly, 8.9% of patients who didn't have indication for endoscopic retrograde cholangiopancreatography according to ultrasonographic findings underwent endoscopic retrograde cholangiopancreatography (p=0.508, kappa=0.72). CONCLUSIONS: Magnetic resonance cholangiopancreatography is valuable in diagnosis of extrahepatic cholestasis in patients suspected with intrahepatic cholestasis according to ultrasonographic findings. Magnetic resonance cholangiopancreatography does not prevent endoscopic retrograde cholangiopancreatography requirement significantly in patients who need diagnostic endoscopic retrograde cholangiopancreatography following ultrasonography.

Usual and unusual causes of extrahepatic cholestasis: assessment with magnetic resonance cholangiography and fast MRI.

Cholestasis may result from hepatocellular (intrahepatic) disease or biliary tract (extrahepatic) abnormalities. Etiologies causing extrahepatic cholestasis are extremely diverse and invasive procedures, such as endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC), were previously required to establish the diagnosis. Due to refinements of magnetic resonance imaging (MRI) techniques, the patient with extrahepatic cholestasis currently can be evaluated noninvasively, and the information revealed frequently exceeds the findings obtained by ERCP and PTC. In this essay, we illustrate the classic MR cholangiographic (MRC) and MRI features of a variety of disorders causing extrahepatic cholestasis, including non-neoplastic disorders of the biliary tract (congenital abnormalities, infectious processes, iatrogenic disorders, and postsurgical complications) and neoplastic conditions (e.g., tumors of the pancreas, biliary tree, liver, ampulla, and regional lymph nodes). In most cases, familiarity with the key MRC features in addition to information obtained via cross-sectional MR images provide sufficient information for adequate lesion characterization.

Incidence and management of Mirizzi syndrome during laparoscopic cholecystectomy.

BACKGROUND: Benign extrinsic obstruction of the hepatic duct, known as "Mirizzi syndrome" (MS), is an uncommon complication of longstanding cholelithiasis. Since laparoscopic cholecystectomy (LC) replaced the open approach, Mirizzi syndrome has regained the interest of biliary surgeons. METHODS: The Swiss Association for Laparoscopic and Thoracoscopic Surgery (SALTS) prospectively collected the data on 13,023 patients undergoing LC between 1995 and 1999. This database was investigated with special regard to patients with Mirizzi syndrome. RESULTS: There were 39 patients (14 men and 25 women; mean age, 61 years) with MS (incidence, 0.3%). Thirty-four patients had type 1 MS and five had type 2. A gallbladder carcinoma was found in four patients (incidence, 11%). In the type 1 group, 23 patients underwent cholecystectomy only, 10 patients had a bile duct exploration and T-tube insertion, and one patient had a Roux-en-Y reconstruction. In three patients with type 2, a hepaticojejunostomy was performed; two others underwent simple closure and drainage (via T-tube) of the biliary fistula. The conversion rate was 74% (24 of 34 patients) in the type 1 group and 100% (five of five patients) for type 2. The overall complication rate was 18%. There were no deaths. CONCLUSIONS: Although MS is rarely encountered during LC, it must be recognized intraoperatively. Conversion to an open approach is often needed, and prior to any surgical intervention, gallbladder cancer must be excluded.

Assessment of the pancreatic and intrapancreatic bile ducts using 0.5-mm collimation and multiplanar reformatted images in multislice CT.

Our objective was to evaluate the ability of multiplanar reformatted (MPR) images combined with 0.5-mm axial images to depict the pancreatic and intrapancreatic bile ducts and compare the results with those of 0.5-mm axial, 2-mm axial, and 6-mm axial images alone. Seventy-seven patients without obstruction of the main pancreatic ducts (MPD) underwent dual-phase helical scanning of the pancreas using multislice computed tomography (MSCT). The MPR images were generated from 0.5-mm-thick images. Visualization of the pancreatic and intrapancreatic bile ducts and their confluence was graded on a four-point scale by a consensus of two radiologists. The results for 0.5-mm axial images in early-phase CT, 2-mm axial images in early-phase CT, MPR images combined with 0.5-mm axial images in early-phase CT, and 6-mm axial images in late-phase CT were then compared. The relationships of the focal pancreatic lesions with the pancreatic ducts were analyzed. The MPR images combined with 0.5-mm axial images were significantly superior to the other three types of images for the visualization of the pancreatic and intrapancreatic bile ducts and their confluence (p<0.01). The depiction rate of the MPD using MPR images combined with 0.5-mm axial images was 94, 94, 95, and 75%, respectively in the head, neck, body, and tail of the pancreas. Accessory pancreatic ducts, intrapancreatic bile ducts, and duct confluence were depicted in 48, 99, and 92%, respectively. In comparison with evaluation based on axial images alone, the use of MPR images more clearly demonstrated the relationship between the lesions and the pancreatic ducts in 14 of 19 lesions. The MPR images combined with 0.5-mm axial images improve the CT depiction of the pancreatic and intrapancreatic bile ducts in comparison with 0.5-mm axial, 2-mm axial, and 6-mm axial images alone.

Wire-guided intraductal US in the assessment of bile duct strictures with Mirizzi syndrome-like features at ERCP.

BACKGROUND: Mirizzi syndrome refers to common hepatic duct obstruction caused by extrinsic compression that is usually from a stone impacted in the cystic duct. The utility of transpapillary intraductal US for assessment of biliary strictures with radiographic features of Mirizzi syndrome was studied retrospectively. METHODS: Intraductal US was performed in 16 patients with a common hepatic duct stricture caused by extrinsic compression and nonvisualization of the gallbladder by endoscopic retrograde cholangiography. An over-the-wire catheter US probe (20 MHz) was inserted into the bile duct. Intraductal US findings were compared with the final diagnoses at surgery. RESULTS: Intraductal US was successful in all patients. The extraluminal cause of the common hepatic duct stricture was detected in 14 patients (87.5%). In 9 patients, intraductal US detected an impacted stone outside the common hepatic duct. Intraductal US demonstrated extraluminal lesions without evidence of a stone in 5 patients, including a mass in 4 and asymmetrical, irregular thickening of the bile duct wall in 1 patient. In the remaining 2 patients, intraductal US demonstrated only a distended gallbladder. CONCLUSIONS: Transpapillary wire-guided intraductal US is useful for assessing biliary strictures with features that suggest Mirizzi syndrome and optimizes management of patients with these findings.

Intraductal ultrasonographic assessment of coagulation depth during endoscopic microwave coagulation therapy in a canine model.

In order to examine the feasibility of endoscopic microwave coagulation therapy (MCT) for the treatment of common bile duct cancer in humans, we investigated the safety and effectiveness of endoscopic MCT with the assistance of intraductal ultrasonography (IDUS). We performed MCT in the canine small intestine as a model because of its similarity in size to the obstructed human common bile duct. Multiple coagulation lesions were made in anesthetized dogs, with the endoscope inserted through a jejunostomy. Under condition "A", the tip of the MCT probe was kept in a fixed position in contact with the mucosa of the intestine, and coagulation was performed with an output of 30 or 50 W for 30 or 10 s, respectively. Under condition "B", the tip of the MCT probe was moved along the intestinal mucosa, and coagulation was performed with an output of 50, 40, or 30 W, all for 10 s. After coagulation, a thin-caliber ultrasonic probe was inserted endoscopically for observation of the effects of coagulation. Each coagulation under condition "A" resulted in degeneration of all layers of the intestine. Coagulation under condition "B" resulted in more localized degeneration, extending from the mucosal layer to the proper muscle layer. By comparison with histologic observations, the accuracy of IDUS in assessing depth of degeneration was 87.5%. Endoscopic microwave coagulation was considered safe and effective, and IDUS was able to accurately assess the effects of microwave coagulation.

A quantitative assessment of liver metabolites during jaundice using three dimensional phosphorus chemical shift imaging.

Phosphorus metabolites in the jaundiced rat liver were studied by three-dimensional phosphorus chemical shift imaging (CSI). Animals were studied at 1, 2, and 3 weeks post-ligation of the common bile duct. Quantitation of metabolites was performed using an external standard. Metabolite T(1) values were assessed in CSI experiments on normal untreated animals. High-performance liquid chromatography (HPLC) was used to measure adenine nucleotides in a separate group of jaundiced rats. 3D-CSI did not detect significant changes in NTP in jaundiced animals relative to baseline controls. At two and three weeks post bile duct ligation, pH was significantly elevated. HPLC data comparing ATP levels to baseline controls also detected no change except for elevated ATP detected on Day 21. (31)P NMR chemical shift imaging may be used to assess liver metabolites under conditions of stress such as jaundice. However, absolute quantitation requires careful attention to many factors including point spread function, correct T(1) values, and adequate signal-to-noise ratio.

Assessment of biliary bicarbonate secretion in humans by positron emission tomography.

BACKGROUND & AIMS: Positron emission tomography (PET) allows imaging and quantitative analysis of organ functions in basal and stimulated conditions. We have applied this method to the study of biliary bicarbonate secretion in humans. METHODS: PET was performed in 5 healthy subjects and 13 patients with hepatobiliary disorders after intravenous injection of NaH11CO3. In each case the study was performed in basal conditions and after secretin stimulation. Positron emission from the hepatic area was scanned, and normalized uptake values for parenchymal and hilar regions were estimated. RESULTS: In healthy individuals, the injection of NaH11CO3 resulted in a peak uptake of the label in parenchymal and hilar regions 2-3 minutes after the injection. In both normal and cirrhotic subjects, secretin administration increased bicarbonate uptake in the parenchymal region, followed by accumulation of the label in the perihilar area. Normal basal uptake with absent response to secretin was registered in extrahepatic biliary obstruction and in untreated primary biliary cirrhosis (PBC). The secretin response was present in patients with PBC undergoing treatment with ursodeoxycholic acid. CONCLUSIONS: PET allows investigation of biliary bicarbonate secretion in humans. An impaired response to secretin was observed in cholestatic conditions. Preliminary data suggest that ursodeoxycholic acid might improve the response to secretin in PBC.

The consequences of a major bile duct injury during laparoscopic cholecystectomy.

Bile duct injury is perhaps the most feared complication of laparoscopic cholecystectomy. The focus of this study was on the immediate and short-term outcome of patients who have undergone repair of major bile duct injuries with respect to hospital stay, perioperative interventions, and reoperations. The records of patients who underwent surgery at three academic hospitals in Philadelphia (Hospital of the University of Pennsylvania, Thomas Jefferson University Hospital, and Graduate Hospital) from 1990 to 1995 for repair of a major biliary injury following laparoscopic cholecystectomy were reviewed. A major biliary injury was defined as any disruption (including ligation, avulsion, or resection) of the extrahepatic biliary system. Small biliary leaks not requiring surgery were excluded. Thirty-two patients sustained major bile duct injuries. The injury was recognized immediately in 10 patients. The remaining 22 patients had pain (59%), jaundice (50%), and/or fever (32%) as the symptom heralding the injury. Bismuth classification was as follows: 13% of patients were class I, 63% were class II, 7% were class III, 7% were class IV, and 10% were class V. Biliary reconstruction included a Roux-en-Y hepaticojejunostomy in 30 patients and two were primary repairs. There was one postoperative death from multiorgan system failure. The mean length of hospital stay after repair was 17 +/- 8 days. Over a mean follow-up period of 11.5 +/- 10.5 months, 11 patients (38%) required 19 emergency readmissions, most commonly for cholangitis. Five patients (17%) required postoperative balloon dilatation for biliary stricture. At follow-up 18 patients (62.0%) remain asymptomatic with normal liver function, eight (28%) are experiencing episodic cholangitis, and three (10%) are asymptomatic with persistently elevated liver function values. The consequences of a major biliary tract injury following laparoscopic cholecystectomy include a complex operative repair resulting in a lengthy postoperative stay with an increased risk of death, an excessive number of perioperative diagnostic and therapeutic studies, frequent readmissions (often as emergencies), and a lifelong risk of restricture. The "cost" to these patients remains enormous.

A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct.

BACKGROUND: Although metallic stents remain patent longer than plastic stents, the optimal palliation of inoperable malignant biliary strictures remains controversial because of the high cost of metallic stents and short patient survival. METHODS: A total of 101 patients (mean age 72.5+/-12.9 years) with malignant strictures of the common bile duct were included in this study, after three exclusions for technical failure (n = 3) and one for noncompliance with study design. The etiology of the strictures included pancreatic cancer (65), cholangiocarcinoma (21), ampullary tumor (3), and metastatic lymph nodes (12). Patients were randomized to receive either an 11.5F polyethylene stent to be exchanged in case of dysfunction (group 1, n = 33), an 11.5F stent to be exchanged every 3 months (group 2, n = 34), or a self-expanding metallic Wallstent (group 3, n = 34). RESULTS: Endoscopic procedures were successful (including complete relief of jaundice) in 97.1 % of cases. Procedure-related morbidity was 11.9%, and mortality was 2.9%. Bilirubinemia after 48 hours (37.2%+/-21.7% decrease from the preoperative level) did not differ between groups. Patients were followed for a mean of 166 days (median 143, range 0 to 596 days). Overall survivals were not different between groups, but complication-free survival for groups 2 and 3 was longer than that of group 1 (p < 0.05). Cumulated hospital days were 7.4+/-1.5, 10.6+/-1.7, and 5.5+/-1.4 (groups 1, 2, and 3, respectively) (p < 0.05; analysis of variance). Cost analysis showed that metallic stents were advantageous in patients surviving more than 6 months, whereas a plastic stent was advantageous in patients surviving 6 months or less. CONCLUSIONS: Metallic stents and plastic stents exchanged every 3 months are valuable alternatives for increasing complication-free survival in patients with malignant strictures of the common bile duct. Metal stents are advantageous in patients with the longest life expectancy.