Biliary Duct Strictures Research Articles

A Multi-Center, Single Arm, Prospective Study of a New Partially Covered Nitinol Self-Expanding Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Background: Covered self-expanding metal stents (SEMS) are widely used for the management of malignant biliary duct strictures. Recently, randomized studies have compared bare and covered biliary SEMS. A new family of biliary SEMS is being introduced, the Fully Covered, Partially Covered, and Uncovered WallFlex biliary SEMS (Boston Scientific, Natick, MA, USA). Methods: The new WallFlex™ Biliary Partially Covered Stent is indicated for palliative treatment of bile duct obstructions caused by malignant neoplasms, and has not yet received regulatory clearance in the United States. Enrollment in a 70 patient prospective multi-center trial is complete and follow-up is ongoing. Primary endpoint is adequate palliation defined as absence of recurrent biliary obstruction until 6 months or death. Secondary measures include evaluation of success of stent placement, complications, and seven common biliary obstructive symptoms assessed at baseline and at each follow-up visit. One consented patient did not receive a stent because of failure to cannulate. Results: Patients are 52% male, mean age 69 (range 34-92). Malignancy was carcinoma of the pancreas in 67% (45), bile duct in 15% (10), gallbladder in 4% (3), ampulla in 4% (3), colon in 3% (2), other in 6% (4), and unreported in 3% (2). 67 patients received 1 stent and 2 patients received 2 stents. 55% of patients received the SEMS de novo and 45% in exchange of a previously implanted plastic stent. Mean procedure duration was 27 minutes (range 5-95). Technical success at stent placement was 94% (65/69). To date 3 patients died due to underlying disease, 1 patient had a stent occlusion due to tumor overgrowth on day 36 managed by placement of a second SEMS inside the Wallflex stent, 8 patients followed to 3 months required no re-intervention, and there were no migrations. From baseline to 1 month the mean number of reported obstructive symptoms improved from 3 to 0.5 and total bilirubin levels reduced on average by 81%. At 1 month 63% of patients were free of all obstructive symptoms. Thus far there were 4 device and/or procedure related complications in 3 patients: 1 cholangitis, 1 acute cholecystitis managed by percutaneous cholecystotomy, and in one patient 1 perforation of the bulbus at stent placement and 1 pancreatitis. Conclusions: This new self-expandable partially covered nitinol stent has proven to be easily implantable, safe, and effective in the short-term palliation of symptoms of biliary obstruction secondary to unresectable or inoperable cancer. Further follow-up is necessary and ongoing to assess long-term adequate palliation by this stent.

Laparoscopic correction of biliary duct stenosis in choledochal cyst

Background/Purposes Laparoscopy has been widely accepted as a technique for the excision of choledochal cyst, but there has been little experience using it as a therapeutic modality for hepatic duct stenosis. The aim of this study is to present our experiences in laparoscopic excision of biliary stenosis and Roux-en-Y reconstruction for patients with choledochal cysts. Methods Eight patients, 3 boys and 5 girls (ranged from 6 months to 12 years; median age, 3.6 years), with hepatic duct stenosis underwent laparoscopic excision of the cyst and ductoplasty, with a Roux-en-Y hepaticoenterostomy between July 2001 and January 2005. Seven of the 8 patients had common hepatic duct stenosis with intrahepatic duct dilatation, and 1 had right hepatic duct stenosis with proximal dilatation. Four ports were inserted for instruments of 3- and 5-mm sizes. Each patient underwent a laparoscopic cholangiography. The gallbladder and dilated bile ducts were completely excised. The strictures of the hepatic ducts were treated by ductoplasty. The cut end of the duct was widened by incising along the anterior wall of the hepatic duct after excision of the narrow segment. By using intraoperative bile duct endoscopy, the optimal level of resection of the common hepatic duct was determined safely without endangering the orifices of the hepatic ducts or leaving any redundant duct, and the stone debris in the bile duct was identified and washed out. The Roux-en-Y jejunal loop was fashioned extracorporeally by exteriorizing the jejunum through the umbilical incision (1.0-1.5 cm) and passed up retrocolically followed by an end-to-side hepaticojejunostomy. Results The median duration of the operation was 4.3 hours (3.8-5.6 hours). Intraoperative bleeding was minimal, with no patients requiring blood transfusion. In 7 of the 8 cases, postoperative hospital stay ranged from 4 to 6 days; the other case had bile leak, which was cured by draining for 26 days without surgical intervention. All the patients had been followed up for 6 to 51 months. They stayed asymptomatic and well with no delayed complication. Conclusions Laparoscopically assisted hepatic ductoplasty is effective and safe for children with choledochal cyst. Bile duct endoscopy proved to be a valuable instrument in showing detailed variations of the biliary system and allowed a safe hepatic hilum exploration and accurate placed hepaticojejunal anastomosis.

Stent versus surgery

Following the introduction of percutaneous and endoscopic biliary drainage there has been an ongoing debate about the indications and outcomes of endoscopic versus surgical drainage in a variety of bilio-pancreatic disorders. The evidence-based literature concerning four different areas of pancreatobiliary diseases have been reviewed. Preoperative endoscopic biliary drainage in patients with obstructive jaundice should not be used routinely but only in selected patients. For patients with biliary leakage and bile duct strictures after a laparoscopic cholecystectomy, endoscopic stent therapy might be first choice and surgery should be used for failures of endoscopic treatment. Surgery is the treatment of choice after transection of the bile duct (the major bile duct injuries). The majority of patients with obstructive jaundice due to advanced pancreatic cancer will undergo endoscopic drainage but for relatively fit patients with a prognosis of more than 6 months, surgical drainage or even palliative resection might be considered. For patients with persistent pain due to chronic pancreatitis surgical drainage combined with limited pancreatic head resection might be first choice for pain relief. Most importantly, the management of patients with these pancreatobiliary diseases should be performed by a multidisciplinary HPB approach and teamwork consisting of gastroenterologists, radiologists and surgeons.

Intraductal Optical Coherence Tomography During ERCP to Investigate Biliary Duct Strictures: Preliminary Report

Background and Aim: Optical coherence tomography (OCT) uses infrared light reflectance to produces high-resolution cross-sectional tissue images. Histology-correlated ex vitro OCT images have identified biliary duct epithelium and subepithelial structures. The aim of this study was to demonstrate the feasibility of biliary intraductal OCT during ERCP and assess the potential of the method to detect malignant biliary strictures. Patients and Methods: A rotating OCT mid focus probe which could be inserted through standard ERCP catheters was used (LightLab, Pentax). The probe generated cross-sectional tissue films of the biliary tract, represented as radial and longitudinal scanning; with 10 μm axial resolution and 1 mm penetration depth. Thirty-two patients were studied during therapeutic ERCP. Biliary strictures had been identified previously. Malignant strictures were defined as those which demonstrated malignant cells in brushing and/or biopsy specimens, and/or EUS-guided FNA and/or surgery. Strictures which did not have malignant cells in resected specimens, or clinical/radiological evidence of disease progression during at least a 12 month follow-up were considered as benign. Two OCT criteria for malignancy were considered: (1) presence of large, non-reflective areas compatible with tumour vessels and (2) unrecognizable layers. Sensitivity and specificity for brushings/biopsies as well as OCT images were calculated. Results: Satisfactory images were obtained from 30 patients; median age: 60 (37-91) years. In two patients, OCT assessment was not performed due to tight strictures. Eighteen patients had malignant and 12 had benign strictures. Malignancy was confirmed by biliary brushings/biopsies in 11/18 (61%) patients. OCT revealed two malignancy criteria in 9/18 (50%) and at least one criterion in 14/18 (77%) patients with malignant strictures. Combining brushings/biopsy with the observation of at least one OCT criterion resulted in the diagnosis of malignancy in 15/18 (83%) patients (Table). There were no complications observed. Conclusions: OCT is feasible during ERCP and may provide information to distinguish between malignant and benign biliary strictures, thus improving the sensitivity and diagnostic accuracy of biliary brushings/biopsies alone. Tabled 1 Brushing/biopsy ≥1 OCT criterion Brushing/biopsy + ≥1 OCT criterion Brushing/biopsy + 2 OCT criteria Sensitivity 11/18 (61%) 14/18 (77%) 15/18 (83%) 14/18 (77%) Specificity 12/12 (100%) 8/12 (67%) 8/12 (66%) 11/12 (92%) Open table in a new tab

NEW STRATEGY TO PREVENT ASCENDING CHOLANGITIS IN LARGER CHOLEDOCHODUODENAL FISTULA

Choledochoduodenal fistula (CDF) is a complication of common bile duct stones or cholangitis in Asia. It is unclear as to which type of the fistula needs surgical treatment. To determine whether the sizes of CDF imply different clinical presentations and treatments, we reviewed 50 patients with CDF and their treatments during a recent 14-year period. For treatments of CDF, we applied the conventional methods, including removal of stone and complete decompression of biliary obstruction to treat the original bile lesions. In addition, according to the sizes of fistula and the frequencies of ascending cholangitis, we proposed the following strategies for fistula treatments: (i) for fistula orifices larger than 1 cm, a transection of common bile duct was applied to prevent the reflux of duodenal juice; (ii) for fistula orifices between 0.5 and 1.0 cm, an effective biliary drainage was applied; and (iii) for fistula orifices less than 0.5 cm, non-surgical treatments were applied. We found that hepatic biliary duct stones and hepatic biliary duct strictures were associated with more severe cholangitis (P = 0.037 and P = 0.009, respectively), but not with the episodes of cholangitis (P = 0.654 and P = 0.664, respectively). In contrast, the sizes of fistula >1 cm were associated with more frequent episodes of cholangitis (r = 0.774; P < 0.001). The larger fistula increases frequency of cholangitis episodes and needs surgical treatment for fistula itself.

Long-term outcome of endoscopic multiple stenting for postoperative benign biliary stenosis

Introduction: One of the most important targets of endoscopic biliary stenting is the postoperative biliary stricture. Endoscopic stenting with multiple endoprothesis for a long period can provide definitive resolution of biliary duct stenosis, however, long term follow-up results are lacking.

Endobiliary brush biopsy: Intra- and interobserver variation in cytological evaluation of brushings from bile duct strictures

Objective. Obtaining cytological specimens by wire-guided endobiliary brushing at the time of endoscopic retrograde cholangiopancreatography (ERCP) is a convenient way to reach a diagnosis. Sensitivity for malignant disease is generally around 50% and specificity around 100%. The present study was designed to assess the reproducibility of the cytological examination.Material and methods. Samples were obtained from 55 consecutive patients with biliary duct strictures that eventually turned out to be caused by malignant disease in 41 patients (73%). The cytology specimens were evaluated twice in different random order with an interval of at least 4 months by two pathologists blinded to the final diagnoses. Suitability for diagnosis (suitable, suboptimal or unsuitable) and cytologic diagnosis (benign, atypical, suspicious for malignancy and malignant cells) were registered. Kappa analysis was applied.Results. Regarding suitability for diagnosis, the two observers reproduced their findings in 84% (kappa 0.76) and 87% (0.59) (p>0.05), while the interobserver variations on the two occasions were 76% and 78% (kappa 0.49 and 0.58, respectively) (p>0.05). Five percent of samples were rated as inadequate for diagnosis in at least one reading; 18% were suboptimal and 62–82% were suitable. The observers reproduced their cytological diagnosis in 77% and 71% (weighted kappa 0.83 and 0.75) (p>0.05), and agreed on the cytological diagnosis in 65% and 73% (weighted kappa 0.65 and 0.75) (p>0.05).Conclusions. The intra- and interobserver agreement in cytological evaluation of endobiliary brushings from bile duct strictures is generally good. The rates of inadequate and suboptimal samples can probably be reduced by modifications of the brush design.

Early diagnosis of pancreatobiliary duct malignancies by brush cytology and biopsy

Two hundred and five preoperative intraductal samplings (brushing and biopsy) were evaluated from 113 patients with biliary or Wirsung duct strictures. One hundred and three strictures could be specified by histology of the operative specimens, autopsy, or by the patients' clinical course. Preoperative diagnostic efficacy depended on the tumor location (it was the best for ampullary and para-papillary tumors), but the average quantitative indices for sensitivity, absolute sensitivity, specificity, positive and negative predictive values, diagnostic accuracy of cytology were 53%, 20%, 100%, 100%, 25%, 59%, respectively. The same values for biopsy were 43%, 34%, 100%, 100%, 36% and 56%. These figures improved after simultaneous cytology and biopsy. Close cooperation with the endoscopist was necessary in cases of negative, inconclusive and dysplastic (27%) samples. Repetition of sampling improved the results by 8%. Among the 26 preoperative false negative cases, sampling-, technical- and interpretative errors occurred in 84%, 4% and 12%, respectively. Revision of samples revealed 4 malignant cases among the false negative cytologic brushings. Reclassification of specimens considering the latest criteria - primary and secondary malignant features, pancreatic intraepithelial neoplasia (PanINs), etc. - resulted in improvement of the diagnostic efficiency.

Case Report

Case Report

ENDOSCOPIC MANAGEMENT OF BILIARY and PANCREATIC DUCTS STRICTURES

ABSTRACTEndoscopic treatment is applied to a relatively large number of biliary and pancreatic duct strictures, and is a practical matter. It is essential to select the most appropriate treatment for each lesion. For instance, when treating malignant biliary stricture, accurate diagnosis of whether surgical treatment is required or not is vital; and in choosing a stent for an inoperable case, location of the stricture, with or without anticancer treatment, prognosis, and management of possible post‐stenting re‐stricture must be taken into consideration. For benign strictures, not only short‐term results in mobility and motality, but also decades of long‐term results must be cautiously questioned. Bearing these in mind, we need to accumulate the worldwide data of the treatments and establish a proper treatment guideline.

Chronic mucoid Pseudomonas aeruginosa cholangitis complicating ERCP in a CF patient

We report a case of P. aeruginosa cholangitis in an adult with cystic fibrosis (CF). The patient had a past history of cholecystectomy and a new finding of intrahepatic biliary duct stricture. Evaluation and treatment with endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous biliary tract drainage was complicated by post-procedure pain and fever. The only organism recovered from biliary drainage was P. aeruginosa. Southern blot analysis of respiratory and biliary cultures confirmed that the isolates were identical. Despite aggressive antibiotic therapy and drainage, persistent cholangitis and infection have not been eradicated after 6 months. The most likely mechanism of infection of the biliary tract was direct introduction of the upper respiratory tract pathogen during the diagnostic procedure.

MR characteristics of acute cholangitis

To describe the MR appearance of acute cholangitis and discuss the role of MR imaging as a diagnostic method in this disease. Of 60 patients with clinical acute cholangitis, 12 were examined with MR before endoscopic retrograde pancreatography (ERCP). A retrospective review was performed of MR and ERCP findings. The MR findings registered were presence of biliary duct dilatation, intraluminal filling defects due to stones or sludge, bands of mucosal oedema of the biliary ducts, intra- and retroperitoneal oedema/fluid, and definition of the cause of obstruction, e.g. stones, stenosis or tumour was made. Acute cholangitis was related to obstruction from choledocholithiasis (n=8), pancreatic cancer (n=1), benign biliary duct stricture (n=1), papillary stenosis (n=1) and without evidence of an obstructing cause (n=1). One patient had an acute obstructive suppurative (toxic) cholangitis. MR imaging has a role in the non-invasive radiographic arsenal of techniques to confirm or exclude the diagnosis of acute cholangitis, especially in older patients where the clinical symptoms may be vague.

MR characteristics of acute cholangitis.

To describe the MR appearance of acute cholangitis and discuss the role of MR imaging as a diagnostic method in this disease. Of 60 patients with clinical acute cholangitis, 12 were examined with MR before endoscopic retrograde pancreatography (ERCP). A retrospective review was performed of MR and ERCP findings. The MR findings registered were presence of biliary duct dilatation, intraluminal filling defects due to stones or sludge, bands of mucosal oedema of the biliary ducts, intra- and retroperitoneal oedema/fluid, and definition of the cause of obstruction, e.g. stones, stenosis or tumour was made. Acute cholangitis was related to obstruction from choledocholithiasis (n=8), pancreatic cancer (n=1), benign biliary duct stricture (n=1), papillary stenosis (n=1) and without evidence of an obstructing cause (n=1). One patient had an acute obstructive suppurative (toxic) cholangitis. MR imaging has a role in the non-invasive radiographic arsenal of techniques to confirm or exclude the diagnosis of acute cholangitis, especially in older patients where the clinical symptoms may be vague.

Significance of non-diagnostic cytology brushings for biliary duct strictures at the time of ERCP

Significance of non-diagnostic cytology brushings for biliary duct strictures at the time of ERCP

External metallic circle in microsurgical anastomosis of common bile duct

Background: Biliary stricture development is one of the most serious problems following biliary tract surgery. Here, we present a new technique for biliary tract reconstruction with an external metallic circle, and the results of this new technique in a rat model. Methods: Twelve male Sprague-Dawley rats (250 to 300 g) were divided into two groups. After transection of the bile duct, standard bile duct reconstruction (without the metallic circle) was performed in group 1 and reconstruction with the external metallic (silver) circle was performed in group 2. At the end of the fourth month, clinical, laboratory biochemical, and histopathologic parameters were compared between the groups. Results: Serum concentrations of alkaline phosphatase (ALP) and operation time were higher in group 1 than in group 2. Differences were statistically significant. In histopathologic examination, biliary duct stricture was seen in group 1. Foreign body reaction and fibrosis in the bile duct wall were seen in group 2. Conclusion: An external metallic circle prevents development of biliary stricture after primary end-to-end bile duct anastomosis in this rat model.

Diagnosis of Cancer Spread Using Percutaneous Transhepatic Biliary Cholangioscopy‐guided Ultrasonography for Malignant Bile Duct Stenosis

The characteristics of sites of intramural cancer spread were examined by comparing the intraductal ultrasonography (IDUS) and wall thickening findings at sites of intramural cancer spread and non-spread, in patients with malignant bile duct stenosis who had undergone percutaneous transhepatic biliary drainage (PTBD). The subjects were ten patients with extrahepatic bile duct cancer, two with pancreatic cancer, one with cancer of the gallbladder, and one with cancer of the papilla of Vater who underwent preoperative IDUS. From these patients, 50 IDUS slices were examined with a congruent relationship with the histologic section of resected tissue. The maximum thickening, minimum thickening, maximum/minimum thickening ratio, and form factor of the medial and lateral margins of the medial hypoechoic layer were determined using diagnostic imaging, and the results were compared at sites of cancer spread and non-spread. Twelve slices were obtained from the site of stenosis, 14 from sites of cancer spread, and 24 from non-spread sites. The maximum thickening, minimum thickening, and maximum/minimum thickening ratio differed significantly between the sites of spread and the non-spread. The absolute values for wall thickening are useful for diagnosing the presence of intramural spread in patients with malignant biliary duct stenosis.

Moderator's Comment: Controversies in Endoscopic Stenting for Biliary and Pancreatic Duct Strictures*

Moderator's Comment: Controversies in Endoscopic Stenting for Biliary and Pancreatic Duct Strictures*

4650 Comparative studies of covered and non-covered expandable metallic stents in autopsy cases with inoperable malignant biliary duct strictures.

Background : Recently, there have been some reports about the usefulness of expandable metallic stents (EMS) covered with polyurethane membrane (PM) in cases with inoperable biliary malignant strictures (IBMS). These reports provoked us to evaluate histological findings of covered and noncovered EMS in 14 autopsy cases with IBMS. Materials and Methods : For these three years, we have studied 14 autopsy cases with IBMS treated by EMS histopathologically. There are 4 cases of bile duct carcinoma (BDCA), 8 cases of pancreatic carcinoma (PCA), one case of hepatocellular carcinoma (HCC), and one case of gastric carcinoma (GCA) with metastasis to hilar lymph node. Of these 14 cases, 5 were treated by EMS covered with PM. Combined radiation therapy was performed in three out of 8 cases with BDCA. Results : The average days of patency was 191 in the non-covered group (NCG), and 234 in the covered group (CG). Tumor ingrowth was detected in 7 out of 9 (78%) cases of NCG, and in 1 out of 5 (20%) cases of CG. This tumor ingrowth in CG was found in a case of PCA whose patency of EMS was 212 days. Overgrowth was detected in 1 out of 9 (11%) cases of NCG, and 1 out of 5 (20%) cases of CG. The debris in EMS was observed in all (100%) cases of NCG, and in 2 out of 5 (40%) cases of CG. The liver abscess was observed in 6 out of 9 (67%) cases of NCG, and in 1 out of 5 (20%) cases of CG. In the non-cancerous lesion of biliary duct, EMS invaded to the submembranous layer and expanded the muscular layer. Necrosis, fibrosis, and granulomatous changes were found in three cases with BDCA treated by radiation. No case with perforation of biliary duct was experienced. Conclusions . EMS covered with PM may play an important role in preventing from tumor ingrowth, debris and liver abscess in cases with IBMS. PM may contribute to keeping longer patency of EMS in cases with IBMS. The risk of tumor ingrowth should be considered in the case treated by EMS with PM.

Analysis of false-negative diagnoses on endoscopic brush cytology of biliary and pancreatic duct strictures: the experience at 2 university hospitals.

Endoscopic brush cytology is a valuable technique for the diagnosis of pancreatobiliary malignancy. Despite its widespread use, the sensitivity of this method has been reported as approximately 50%. The specificity is usually higher than 95%. Few reports have systematically analyzed the reasons for this relatively low sensitivity. To determine the rate and reasons for false-negative diagnoses in endoscopic brushing cytology of biliary and pancreatic ducts based on the results of sensitivity, specificity, accuracy, and positive and negative predictive values. Retrospective analysis of laboratory data and slide review of false-negative cases. Two tertiary care state university hospitals. A total of 183 pancreatobiliary brushing specimens obtained from patients undergoing endoscopic retrograde cholangiopancreatography for biliary or pancreatic duct disease for a 4- to 5-year period. Endoscopic retrograde cholangiopancreatography brushings. Determination of sensitivity, specificity, accuracy, and positive and negative predictive values. Analysis of false-negative results. The sensitivity, specificity, accuracy, and positive and negative predictive values, overall, were 48%, 98%, 79%, 92%, and 76%, respectively. Sampling error was a major cause of false-negative diagnoses (67%), followed by interpretive (17%) and technical errors (17%). Improvements in sensitivity and diagnostic accuracy for cancer of the pancreatobiliary tract can be achieved by optimizing slide preparatory techniques. Also, enhancement of the cytologist's diagnostic skills enables the identification of the morphologic features of premalignant lesions. Repeat brushings are indicated for suspicious or negative results not consistent with the clinical or radiologic findings.

Percutaneous intraductal sampling for cyto-histologic diagnosis of biliary duct strictures.

Percutaneous transhepatic biliary drainage (PTBD) allows ductal material to be collected for cyto-histologic examination. We evaluated the data from a large series of patients with a PTBD in whom endobiliary cyto-histologic sampling techniques were employed in order to define a strategy for their use in the diagnostic work-up. Ductal samples for cyto-histologic examination were obtained from 409 consecutive patients with a PTBD for stenosing lesions of the biliary tree. Bile aspirate cytology was performed for all patients and ductal biopsy specimens were obtained, generally after negative cytology, from 49 of them (11.9%), all candidates for a therapeutic procedure. The cyto-histologic results of intraductal sampling were compared with pathologic surgical data in 210 patients and with clinical-radiologic follow-up in 199. Overall, 22 out of the 409 patients had a final diagnosis of benign stenosis and 177 had samples positive for neoplastic disease. The sensitivity of bile cytology was 43.8% while ductal biopsies showed a sensitivity of 60.4%. The combination of the two sampling techniques achieved a sensitivity of 65.1%. For both sampling methods the specificity was 100%. Hilar metastases from neoplastic lesions of the GI tract and primary lesions of the biliary ducts showed the highest sensitivity. Cyto-histologic assessment of stenosing lesions of the biliary ducts is mandatory when highly sophisticated interventions (e.g. wide hepatic resection or liver transplantation) or non-surgical treatments are envisaged. The collection of cyto-histologic samples from bile ducts, in patients with a percutaneous bile drainage, is an easy, safe and valuable method to obtain the diagnosis. In view of the absence of false positive results in our series and in others, intraductal biopsy serves no purpose when positive exfoliative cytology is positive for malignancy. In the presence of negative cytology it is felt that an intraductal biopsy should be mandatory when the choice of a therapeutic program depends on the result of the cyto-histologic diagnosis.