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Incidence and risk factors for biliary and pancreatic stent migration.

Endoprostheses are commonly used in the treatment of biliary and pancreatic disorders. The frequency of and potential risk factors for stent migration, however, remain largely unknown. From January 1986 to June 1990, 807 biliary and pancreatic stents were placed at our institution. Our study analyzed the occurrence of stent migration among the 589 stents for which follow-up data were available. Results demonstrated incidence rates of 4.9 and 5.9% for proximal (into the duct) and distal (out of the duct) biliary stent migration, respectively. Likewise, incidence rates of 5.2 and 7.5% were observed for proximal and distal pancreatic stent migration, respectively. Malignant strictures, larger diameter stents, and shorter stents were significantly associated with proximal biliary stent migration. Sphincter of Oddi dysfunction and longer stents were associated with proximal pancreatic stent migration. Migration of stents out of the common bile duct occurred more frequently in papillary stenosis. No other significant risk factors for distal migration were found. These results indicate that stent migration is an important complication. Multiple risk factors were associated with stent migration and need to be considered in the development of new stent types.

Common Bile Duct↗

The role of ERCP in the diagnosis and treatment of idiopathic recurrent pancreatitis in children and adolescents.

ERCP was performed in 51 patients, aged 1 to 18 years, as part of diagnostic evaluation for recurrent pancreatitis without obvious cause or as therapeutic intervention. ERCP was successful in 50 patients (98%). Thirty-four patients (68%) had anatomic findings indicating a possible cause of recurrent pancreatitis. Three patients (6%) had findings suggestive of sphincter of Oddi dysfunction. Eighteen of the 37 patients (49%) with ductal abnormalities underwent endoscopic therapy, with a favorable outcome in 15 (83%). Eleven patients were treated surgically, and 8 of these patients (73%) improved symptomatically. Eight patients received no treatment, and 6 of them (67%) had recurrent bouts of clinical pancreatitis. One mild case of pancreatitis (1.9%) occurred after ERCP, and 3 mild cases followed endoscopic therapy. In conclusion, ERCP is a relatively safe technique that produces opacification of the desired ductal system with a high degree of accuracy and provides useful information in the evaluation of children with idiopathic recurrent pancreatitis. These data suggest that endoscopic pancreatic therapy may result in symptomatic improvement, eliminating the need for surgery in selected children. Furthermore, the study demonstrates that manipulation of the pancreatic duct is comparatively safe and less hazardous than formerly believed.

Adolescent↗

Outpatient therapeutic ERCP: a series of 262 consecutive cases.

BACKGROUND: Because of possible complications, it has been common practice to admit most if not all patients undergoing therapeutic ERCP. Therefore, little descriptive data exist on the safety of outpatient therapeutic ERCP. METHODS: We assessed 262 consecutive ERCPs in 209 patients undergoing outpatient therapeutic ERCP over a 5-year period, with particular attention to the development of complications. All outpatient endoscopic sphincterotomies and stent placements performed over a 5-year period were prospectively entered into an ongoing data base that was used for the analysis. In addition, hospital and office records for all patients were retrospectively reviewed, including a 30 to 45 day follow-up in a private office setting. RESULTS: Suspected or documented choledocholithiasis was the most common indication for ERCP and was present in 132 (50%), followed by malignant obstruction in 77 (29%), type I sphincter of Oddi dysfunction (on the basis of symptoms, liver test abnormalities, and bile duct dilatation) in 36 (14%), chronic pancreatitis in 10 (3.8%), HIV cholangiopathy in 4 (1.5%), and other conditions in 3 (1.1%). Overall, 181 patients (69%) underwent a sphincterotomy. The 30-day post-ERCP complication rate was 5.7% (95% CI: 3.2% to 9.3%), occurring in 15 of 262 cases. Complications necessitating hospitalization developed in 9 of the 262 ERCPs for a rate of 3.4% (95% CI: 1.6% to 6.4%). The mean duration of hospital stay among patients admitted for a complication was 2.7 +/- 1.8 days (range, 1 to 7 days). All patients were discharged without permanent sequelae. No 30-day procedure-related fatalities were reported. CONCLUSION: In this selected series of 262 consecutive cases, endoscopic sphincterotomy and stent placement were safely performed in an ambulatory setting. Prior to recommending a generalized change in existing practice, however, this finding requires validation with larger series of cases, including the performance of other outpatient therapeutic ERCP techniques.

Adolescent↗

Pure cut electrocautery current for sphincterotomy causes less post-procedure pancreatitis than blended current.

BACKGROUND: Complications after endoscopic biliary sphincterotomy occur in 8% to 10% of patients when studied prospectively. It is not known whether the type of electrocautery current affects this rate. Theoretically, less edema of the ampulla after a pure cutting current sphincterotomy could decrease the risk of pancreatitis although the risk of postsphincterotomy hemorrhage might be greater. METHODS: One hundred seventy patients undergoing sphincterotomy were prospectively randomized to either a blended or pure cut current on the Valleylab electrosurgical unit. The settings were a blended three current at a power setting of 30 watts/sec for both the cut and coagulation currents or a pure cut current at a power setting of 30 watts/sec. The individual determining whether a complication occurred was blinded to the type of current used, and all patients were hospitalized for 24 hours post-procedure. Pancreatitis was defined as mild if fewer than 5 days, moderate if 5 to 14 days, and severe if more than 14 days of hospitalization were required. RESULTS: Indications for sphincterotomy were choledocholithiasis in 111 patients, sphincter of Oddi dysfunction in 36 patients, stent placement in 15 patients, and miscellaneous in 8 patients. There were a total of 16 complications in 170 patients (9%); 4 (5%) were in the pure cut current group of 86 patients (one episode of bleeding that required transfusion of 4 U and three episodes of mild pancreatitis), and 12 (14%) were in the blended current group of 84 patients (7 mild, 2 moderate, and 1 severe pancreatitis; 1 case of cholangitis; and one episode of bleeding that required transfusion of 2 U). There were significantly fewer complications in the pure cut group (p < 0.05 by chi-square). CONCLUSION: The use of pure cut current is associated with a lower incidence of pancreatitis, the most common ERCP complication, than with blended current sphincterotomy. An insufficient number of patients were studied to comment on the relative risk of hemorrhage. However, because the complication of hemorrhage is much less common than pancreatitis, pure cut current is safer overall.

Acute Disease↗

Same-day discharge after endoscopic biliary sphincterotomy: observations from a prospective multicenter complication study. The Multicenter Endoscopic Sphincterotomy (MESH) Study Group.

BACKGROUND: Same-day discharge after endoscopic biliary sphincterotomy (ES) is a common clinical practice, but there have been few data to guide appropriate selection of patients. Using a prospective, multicenter database of complications, we examined outcomes after same-day discharge as it was practiced by a variety of endoscopists and evaluated the ability of a multivariate risk factor analysis to predict which patients would require readmission for complications. METHODS: A 150-variable database was prospectively collected at time of ES, before discharge and again at 30 days in consecutive patients undergoing ES at 17 centers. Complications were defined by consensus criteria and included all specific adverse events directly or indirectly related to ES requiring more than 1 night of hospitalization. RESULTS: Six hundred fourteen (26%) of 2347 patients undergoing ES were discharged on the same day as the procedure, ranging from none at 6 centers to about 50% at 2 centers. After initial observation and release, readmission to the hospital for complications occurred in 35 (5.7%) of 614 same-day discharge patients (20 pancreatitis and 15 other complications, 3 severe). Of the same-day discharge patients, readmission was required for 14 (12.2%) of 115 who had at least one independently significant multivariate risk factor for overall complications (suspected sphincter of Oddi dysfunction, cirrhosis, difficult bile duct cannulation, precut sphincterotomy, or combined percutaneous-endoscopic procedure) versus 21 (4.2%) of 499 without a risk factor (odds ratio 3.1: 95% confidence interval [1.6, 6.3], p < 0.001). Of complications presenting within 24 hours after ES, only 44% presented within the first 2 hours, but 79% presented within 6 hours. CONCLUSIONS: Same-day discharge is widely utilized and relatively safe but results in a significant number of readmissions for complications. For patients at higher risk of complications, as indicated by the presence of at least one of five independent predictors, observation for 6 hours or overnight may reduce the need for readmission.

Adult↗

Cholecystokinin cholescintigraphy: clinical indications and proper methodology.

Cholecystokinin is a useful diagnostic adjunct to cholescintigraphy. Clinical indications include contracting the gallbladder before cholescintigraphy in patients fasting greater than 24 hours, during cholescintigraphy to diagnose sphincter of Oddi dysfunction, and after cholescintigraphy to exclude acute acalculous cholecystitis, differentiate common duct obstruction from normal variation, and to confirm the diagnosis of chronic acalculous cholecystitis. Proper methodology is mandatory for a diagnostically useful test. Data presented shows that a 3-minute infusion of 0.01 or 0.02 microg/kg is nonphysiologic and often results in ineffective contraction similar to that seen with a bolus infusion. Normal gallbladder ejection (GBEF) values cannot be established using a 3-minute infusion because of the wide variability in response. Instead, infusions of 30 or 60 minutes are required. Normal GBEF values have been established for these methods and are 30% and 40%, respectively.

Biliary Tract↗

Interventional treatment of acute and chronic pancreatitis. Endoscopic procedures.

The role of therapeutic endoscopy in the treatment of acute and chronic pancreatitis has expanded dramatically over the past 10 years. Drainage of pseudocysts and even organized pancreatic necrosis when localized are becoming commonplace. Other areas in which therapeutic endoscopy has been shown to be efficacious include severe biliary pancreatitis, pancreatic duct disruptions, strictures, and obstructive calculi. Its role in the management of acute recurrent pancreatitis with presumed Oddi's sphincter dysfunction or pancreas divisum continues to be defined. The cost-effectiveness and minimally invasive nature of endoscopic therapy compared with surgery should ensure the continued development of these techniques. More controlled, prospective data are required.

Acute Disease↗

Causes of acute and recurrent pancreatitis. Clinical considerations and clues to diagnosis.

The causes of acute pancreatitis are well documented and usually are divided into alcohol-induced, gallstone, miscellaneous, and idiopathic when no immediate cause is found. Clinically, the cause is either immediately discernable from the history and a few standard investigations, less obvious and requiring more detailed studies, or obscure and even speculative. The physician can whittle away at the idiopathic group by increasingly recognizing causes such as biliary sludge or microlithiasis, sphincter of Oddi dysfunction, hereditary pancreatitis, cystic fibrosis, or autoimmune causes. The prevalence of these and other rare conditions is the focus of intense research. Whether these increasingly recognized causes will significantly alter the current incidence of 10% to 30% of cases classified as idiopathic pancreatitis, only time will tell.

Acute Disease↗

Improved stent characteristics for prophylaxis of post-ERCP pancreatitis.

BACKGROUND & AIMS: Pancreatic stenting is an effective method to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in high-risk patients. This retrospective study evaluated the impact of modified stent characteristics on the rate of post-ERCP pancreatitis, spontaneous stent dislodgment, and stent-related sequelae. METHODS: A total of 2283 patients underwent 2447 ERCPs over a 6-year period with placement of 3-4F diameter, unflanged pancreatic stents. The indication for stenting was pancreatitis prophylaxis predominantly in suspected sphincter of Oddi dysfunction (SOD), pancreas divisum therapy, and precut sphincterotomy. An abdominal radiograph was obtained 10-14 days later to assess spontaneous stent passage. Post-ERCP pancreatitis was defined according to established criteria. A total of 479 patients underwent repeat ERCPs after an initial ERCP with pancreatic stent placement. The prestenting pancreatogram was then compared with follow-up studies. RESULTS: The pancreatitis rate with 3F, 4F, 5F, and 6F stents was 7.5%, 10.6%, 9.8%, and 14.6%, respectively (3F vs. 4F, 5F, 6F: P = 0.047). Spontaneous stent dislodgment was 86%, 73%, 67%, and 65%, respectively (3F vs. 4F, 5F, 6F: P < 0.0001). The frequency of ductal changes was 24% in patients with 3-4F stents compared with 80% with 5-6F stents. Ductal perforation from the stents occurred in 3 patients (0.1%). CONCLUSIONS: Small diameter (3-4F), unflanged pancreatic stents are more effective than the traditionally used stents (5-6F) in preventing post-ERCP pancreatitis. Stent-induced ductal changes and the need for endoscopic removal are also significantly less with 3-4F stents. The 3F stent appears to be superior in all aspects studied. Additional studies are needed to define the ideal method to eliminate post-ERCP pancreatitis.

Acute Disease↗

The use of botulinum toxin for the treatment of gastrointestinal motility disorders.

Botulinum toxin type A is used extensively for the management of gastrointestinal smooth muscle disorders. This review is a comprehensive summary of the current status of this therapy. It includes English-language research from 1966 to 2003 and relevant abstracts from subspecialty meetings from the past 3 years. Botulinum toxin appears to be beneficial for achalasia, gastroparesis, sphincter of Oddi dysfunction, anal fissure and anismus. Very few placebo-controlled trials have been performed despite widespread use of toxin for the past 10 years. Botulinum toxin appears to be safe and side effects are uncommon. Despite uncontrolled data, botulinum toxin is now used for a variety of spastic disorders of GI smooth muscle. In some instances this therapy may preclude the need for more invasive treatments. Controlled trials are needed.

Anti-Dyskinesia Agents↗

Octreotide 24-h prophylaxis in patients at high risk for post-ERCP pancreatitis: results of a multicenter, randomized, controlled trial.

BACKGROUND: Pharmacological prophylaxis of post-ERCP pancreatitis is costly and not useful in most non-selected patients, in whom the incidence of pancreatitis is 5% or less. However, it could be useful and probably cost-effective, in patients at high risk for this complication, where the post-procedure pancreatitis rate is 10% and more. AIM: To assess the efficacy of octreotide in reducing the incidence and severity of post-ERCP pancreatitis and procedure-related hospital stay, in subjects with known patient-related risk factors. METHODS: A total of 120 patients were randomly allocated to receive octreotide or not, in a multicentre, randomized, controlled trial. The drug was given subcutaneously, 200 microg t.d.s., starting 24 h before the ERCP procedure, in patients with either sphincter of Oddi dysfunction, or a history of relapsing pancreatitis or post-ERCP pancreatitis, or who were aged under 35 years, or who had a small common bile duct diameter (< 8 mm). RESULTS: A total of 114 patients (58 in the octreotide group and 56 in the control group) completed the trial. Post-procedure pancreatitis occurred in seven octreotide-treated patients (12.0%) and eight controls (14.3%). The two groups showed no significant differences in the incidence or severity of pancreatitis. Twenty-four hours after the procedure, severe hyperamylasemia (more than five times the upper normal limit) without pancreatic-like pain was recorded in three octreotide-treated patients (5.2%) and six controls (10.7%), the difference being not significant. CONCLUSION: Twenty-four-hour prophylaxis with octreotide proved ineffective in preventing post-ERCP pancreatitis and in avoiding 24-h severe hyperamylasemia in high-risk patients.

Adult↗

What are the risks of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography?

BACKGROUND: Diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) has been practised widely over the last 20 years, and it has revolutionized the diagnosis and management of biliary and pancreatic conditions. More recently newer techniques (magnetic resonance imaging) for diagnosis and therapy (laparoscopic biliary surgery) have evolved. The present paper evaluates the risks of ERCP procedures in a modern setting. METHODS: A prospective audit of all ERCP carried out by a single unit across two campuses over 12 months was undertaken. All procedures were included and predetermined morbidity criteria were recorded and evaluated by independent observers who did not perform the procedures. RESULTS: During this period 372 procedures were performed. A total of 9.4% of procedures failed to achieve the preprocedure-stated goal. There were five deaths (30-day mortality of 1.3%) and in 16 patients complications were recorded (morbidity of 4.3%). Two clinical and two technical factors were shown to be associated with the morbidity and mortality by multiple logistic regression analysis: diagnosis of sphincter of Oddi dysfunction; presence of jaundice; need to perform percutaneous transhepatic drainage of an obstructed biliary system after a failed endoscopic approach; and multiple ERCP. CONCLUSIONS: These results compare favourably with results from other reported series and serve to illustrate the relative safety of diagnostic and therapeutic ERCP.

Adolescent↗

Prediction of pancreatitis following endoscopic retrograde cholangiopancreatography by the 4-h post procedure amylase level.

BACKGROUND: Pancreatitis is the commonest and most significant complication of endoscopic retrograde cholangiopancreatography (ERCP). Early detection of post-ERCP pancreatitis would allow the safe discharge of day-case patients and targeted use of preventive therapies. Clinical diagnosis is inaccurate, and the aim of this study was to evaluate the 4-h post-ERCP hyperamylasemia as a predictor of pancreatitis. METHODS: Two hundred and sixty-three consecutive ERCPs performed at one center were prospectively analyzed, examining patient and procedure characteristics, as well as the amylase level as predictors of pancreatitis. RESULTS: Younger age (< 25 years), Sphincter of Oddi dysfunction, pancreatogram and failed cannulation were risk factors for pancreatitis; sphincterotomy conferred an increased risk, which was not statistically significant. Hyperamylasemia was a highly sensitive and moderately specific predictor of pancreatitis. A cut-off level of 1.5-fold higher than normal was useful for the exclusion of pancreatitis, while a cut-off level of threefold higher than normal was more specific, so as to target potential preventive therapies. CONCLUSIONS: The 4-h post-ERCP amylase level is a useful test to base management decisions on. It needs to be interpreted in conjunction with clinical assessment as well as identifiable risk factors related to the patient or the procedure.

Adolescent↗

Therapeutic pancreatic endoscopy.

A number of endoscopic interventions have expanded the range of treatment options in symptomatic pancreatic diseases. Early endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (ES) appear to be beneficial in patients with severe acute biliary pancreatitis. Endoscopic pancreatic sphincterotomy can be safely performed with high technical success rates in patients with chronic pancreatitis. Routine additional biliary ES or drainage procedures are not apparently necessary. Stenting can be limited to the treatment of dominant pancreatic duct strictures. In patients with sphincter of Oddi dysfunction, temporary placement of pancreatic stents reduces the morbidity associated with ES. Transpapillary or transmural endoscopic drainage achieves resolution of pancreatic pseudocysts in the majority of selected patients. Drainage procedures with endoscopic ultrasound guidance can potentially expand the indications and reduce the procedure-related morbidity. Therapeutic endoscopy should be considered in symptomatic patients with pancreas divisum, as well as in selected children with pancreatic diseases. Most of the published studies on therapeutic pancreatic endoscopy have been conducted retrospectively. Additional prospective controlled trials are warranted to allow further evaluation of the impact of these methods on the clinical outcome in comparison with alternative treatment strategies.

Adult↗

Bedside scoring system to predict the risk of developing pancreatitis following ERCP.

BACKGROUND AND STUDY AIMS: Pancreatitis is the most common significant complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of the present study was to develop a simple scoring system that clinicians can use to predict the risk of post-ERCP pancreatitis. PATIENTS AND METHODS: We analyzed a prospectively assembled database of 1835 ERCP procedures at a single referral hospital. Multivariate logistic regression analysis was performed to identify risk factors for pancreatitis and determine their relative contributions. From these results, a scoring system was constructed. The performance of the scoring system was assessed on the entire procedure database and in selected subgroups. RESULTS: Multivariate analysis yielded four risk factors: pain during the procedure, cannulation of the pancreatic duct (PD), previous post-ERCP pancreatitis, and number of cannulation attempts. Based on the regression model, the scoring system was: 4 points for pain, 3 points for PD cannulation, 2 points for a history of post-ERCP pancreatitis, and 1 - 4 points depending on the number of cannulation attempts. A total score of 1 - 4 points was associated with a low risk of pancreatitis (< 2 %), while a score of 5 - 8 points had an intermediate risk (7 %), and a score of 9 or above had a high risk (28 %). CONCLUSIONS: This simple scoring system may enable clinicians to stratify patients into low-risk, medium-risk, and high-risk groups for the development of post-ERCP pancreatitis. In addition, when patients with suspected sphincter of Oddi dysfunction and patients who underwent minor papilla cannulation were analyzed separately, the scoring system was able to predict accurately the pancreatitis risk of these patients as well.

Adult↗

Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis.

BACKGROUND AND STUDY AIM: The identification of factors which increase the risk of acute pancreatitis, the most common and most severe complication of endoscopic retrograde cholangiopancreatography (ERCP), is of considerable importance. However, in four large prospective studies, the reported incidence of identified risk factors for post-ERCP pancreatitis was found to be variable. The aim of this study was to identify the most important risk factors for post-ERCP pancreatitis. MATERIAL AND METHODS: We performed a meta-analysis of 15 prospective clinical studies, selected out of 52 reviewed articles, in which risk factors for pancreatitis were identified. Of the 14 risk factors identified, five were patient characteristics and nine were related to the endoscopic technique. RESULTS: When patient-related risk factors were analysed, the relative risk for suspected sphincter of Oddi dysfunction was 4.09 (95 % CI 3.37 to 4.96; P < 0.001); for female gender, 2.23 (95 % CI 1.75 to 2.84, P < 0.001); and for previous pancreatitis, 2.46 (95 % CI 1.93 to 3.12, P < 0.001). Two endoscopy-related factors were confirmed: for precut sphincterotomy the relative risk was 2.71 (95 % CI 2.02 to 3.63, P < 0.001); for pancreatic injection the relative risk was 2.2 (95 % CI 1.6 to 3.01, P < 0.001). CONCLUSIONS: This meta-analysis provides a clear basis for planning pharmacological studies or studies of new endoscopic techniques in patients at high risk of developing post-ERCP pancreatitis. Knowing which patients are most at risk may also make it easier to decide who should be considered unsuitable for same-day discharge.

Acute Disease↗

Therapeutic biliary endoscopy.

Some steps of progress have been seen in the area of biliary therapeutic endoscopy, in the understanding and management of primary sclerosing cholangitis, problems relating to liver transplantation, malignant biliary strictures, and complications after endoscopic retrograde cholangiopancreatography, as well as sphincter of Oddi dysfunction. These topics are reviewed here.

Biliary Tract Diseases↗

Experience with a catheter-based ultrasound probe in the bile duct and pancreas.

BACKGROUND AND STUDY AIMS: Complete examination of the biliary tree and pancreatic duct may be difficult or unsuccessful using conventional imaging instruments. The purpose of this study was to evaluate the cannulation success rate, clinical utility, and safety of a new catheter-based ultrasound probe (CBUSP) used in the biliary tree and pancreas. PATIENTS AND METHODS: The probes used in this study are manufactured by Microvasive (Watertown, MA, U.S.A.) and were 6.2 Fr in diameter, operated at 12.5 MHz. Thirty-six patients (11 with malignant bile-duct strictures, 12 with benign bile-duct strictures, two with bile duct stones, three with pancreatic duct strictures, one with a pancreatic cyst, one with pancreas divisum, three with sphincter of Oddi dysfunction, and three normal) underwent examination with a CBUSP. RESULTS: Cannulation was successful in all 36 patients. The hepatic artery and portal vein could be visualized with the probe in the proximal bile duct in 81% and 94% of the cases, respectively. The portal vein could not be adequately visualized in any patients when the probe was in the distal bile duct. The mean thickness of the normal bile duct wall was 0.17 cm, and the mean wall thicknesses proximal to a benign and malignant stricture were 0.16 and 0.17 cm, respectively. The mean thicknesses of benign and malignant biliary strictures were 0.32 cm and 0.31 cm, respectively (not significant). Eight of 12 benign biliary strictures (67%) and five of 11 malignant strictures (45%) were symmetrical. However, no obvious differences could be identified between benign and malignant biliary strictures. There were no catheter related complications. CONCLUSIONS: Further catheter modifications are needed, but it appears to be feasible to assess vascular invasion in cholangiocarcinoma and to characterize biliary strictures in a way that may be able to influence therapy options in some patients. The currently available CBUSP cannot distinguish between benign and malignant strictures. However, with technical modifications, this may be possible in the future. The clinical usefulness of CBUSP in the pancreas awaits further investigation, but pancreatic imaging is feasible.

Adult↗