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NIH state-of-the-science statement on endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis and therapy.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the use of endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis and therapy. PARTICIPANTS: A non-Federal, non-advocate, 13-member panel representing the fields of gastroenterology, hepatology, clinical epidemiology, oncology, biostatistics, surgery, health services research, radiology, internal medicine, and the public. In addition, experts in these same fields presented data to the panel and to a conference audience of approximately 300. EVIDENCE: Presentations by experts; a systematic review of the medical literature provided by the Agency for Healthcare Research and Quality; and an extensive bibliography of ERCP research papers, prepared by the National Library of Medicine. Scientific evidence was given precedence over clinical anecdotal experience. CONFERENCE PROCESS: Answering predefined questions, the panel drafted a statement based on the scientific evidence presented in open forum and the scientific literature. The draft statement was read in its entirety on the final day of the conference and circulated to the experts and the audience for comment. The panel then met in executive session to consider these comments and released a revised statement at the end of the conference. The statement was made available on the World Wide Web at http://consensus.nih.gov immediately after the conference. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. CONCLUSIONS: In the diagnosis of choledocholithiasis, magnetic resonance cholangiopancreatography (MRCP), endoscopic ultrasound (EUS), and ERCP have comparable sensitivity and specificity. Patients undergoing cholecystectomy do not require ERCP preoperatively if there is low probability of having choledocholithiasis. Laparoscopic common bile duct exploration and postoperative ERCP are both safe and reliable in clearing common bile duct stones. ERCP with endoscopic sphincterotomy (ES) and stone removal is a valuable therapeutic modality in choledocholithiasis with jaundice, dilated common bile duct, acute pancreatitis, or cholangitis. In patients with pancreatic or biliary cancer, the principal advantage of ERCP is palliation of biliary obstruction when surgery is not elected. In patients who have pancreatic or biliary cancer and who are surgical candidates, there is no established role for preoperative biliary drainage by ERCP. Tissue sampling for patients with pancreatic or biliary cancer not undergoing surgery may be achieved by ERCP, but this is not always diagnostic. ERCP is the best means to diagnose ampullary cancers. ERCP has no role in the diagnosis of acute pancreatitis except when biliary pancreatitis is suspected. In patients with severe biliary pancreatitis, early intervention with ERCP reduces morbidity and mortality compared with delayed ERCP. ERCP with appropriate therapy is beneficial in selected patients who have either recurrent pancreatitis or pancreatic pseudocysts. Patients with type I sphincter of Oddi dysfunction (SOD) respond to endoscopic sphincterotomy (ES). Patients with type II SOD should not undergo diagnostic ERCP alone. If sphincter of Oddi manometer pressures are >40 mmHg, ES is beneficial in some patients. Avoidance of unnecessary ERCP is the best way to reduce the number of complications. ERCP should be avoided if there is a low likelihood of biliary stone or stricture, especially in women with recurrent pain, a normal bilirubin, and no other objective sign of biliary disease. Endoscopists performing ERCP should have appropriate training and expertise before performing advanced procedures. With newer diagnostic imaging technologies emerging, ERCP is evolving into a predominantly therapeutic procedure.

Acute Disease↗

Results of cholecystectomy without intraoperative cholangiography.

BACKGROUND: To determine if cholecystectomy can be performed satisfactorily without the use of adjunctive intraoperative cholangiography (IOC), we planned a retrospective analysis at a Canadian university teaching hospital. METHODS: General operative morbidity and mortality (in particular, occurrences and complications of missed choledocholithiasis and reoperations for same, and occurrences of bile duct injuries and bile leaks) were noted and analyzed for a consecutive series of cholecystectomies from a single practice, carried out without IOC. MAIN RESULTS: In general, choledocholithiasis could be identified and treated before the operation; missed cases were infrequent and were treatable without reoperation. No major injuries to the bile duct were encountered. CONCLUSIONS: IOC appears to be optional with cholecystectomy; cholecystectomy can be performed without IOC safely in the defined setting, without related major complications from missed choledocholithiasis or excess occurrence of bile-duct injury.

Adolescent↗

Evaluation of the diagnostic accuracy of the endoscopic ultrasonography results in the patients examined in a period of three years.

INTRODUCTION: Endoscopic ultrasonography (EUS) is a well-established method of evaluating patients with gastrointestinal diseases, especially malignancies. EUS is like other similar endoscopy techniques, based on high frequency ultrasonography. This high level technology allows examination of tissue to almost microscopic level, not only in digestive system but its surrounding structures. OBJECTIVE: The aim of this study was to determine the contribution of endoscopic experience, based on the number of endosopic ultrasonography examination performed in the three years period, to obtain 80% diagnostic accuracy with staging of the disease in order to achieve a 30-60% change rate in treatment decisions which is accepted standard. RESULTS: First group with 210 patients was examined in the first year of work; 325 examined in the second year of work and 295 in the third year. DIAGNOSTIC: Accuracy in the first year of work, were 45% (p<0.001 for the choledocholithiasis; p=0.197 for the pancreatic cancer; p=0.195 for LN detection in the gastric cancer). In the second year of work diagnostic accuracy were 78%/p=0.550 for the choledocholithiasis; p=0.228 for the pancreatic cancer; p=0.503 for LN detection in the gastric cancer/. Diagnostic accuracy in the third year of work were 81%/p<0.001 for the choledocholithiasis; p=0.018 for the pancreatic carcinoma; p=0.042 LN detection in the gastric cancer/. CONCLUSION: Application of Endoscopic ultrasonography in diagnostics, based on number of EUS examination performed, after three years of work, achieved 80% diagnostic accuracy, compared to standard imaging methods and results of surgery in staging of the disease. EUS results made a change in treatment decisions in 30-60% of patients which is world standard and completely justify use of endoscopic ultrasonography in clinical practice.

Adult↗

Choledochoduodenostomy: a study of 28 consecutive cases.

OBJECTIVES: Choledocholithiasis is a common problem in South Asia. Proper drainage of the CBD is essential to reduce the chance of residual stones and recurrent stones. The paper highlights the surgical management of choledocholithiasis by side to side choledochoduodenostomy and the post surgical complications. METHOD: 28 cases of choledocholithiasis treated by choledochoduodenostomy between March 1995 and June 2003 were studied. After pre operative diagnosis and per operative confirmation, side to side choledochoduodenostomy was done. It is a triangulated anastomosis between the bile duct and post bulbar duodenum using single layer interrupted suture. The cases were meticulously followed up for detecting complications RESULTS: 79% of the patients who underwent choledochoduodenostomy were female and majority (43%) belonged to the 51 to 60 age group. All the patients selected for CDD had a dilated common duct of at least 1.5 cm diameter and 71% of them had multiple stones. 79% were asymptomatic during the follow up, two patients developed wound infection. 18% developed alkaline reflux gastritis and only one patient suffered from recurrent cholangitis because of inadequate stoma size. No case of sump syndrome was observed in this series. CONCLUSION: Side to side CDD is an easy, effective and definitive method of decompression, especially when there are multiple stones in a dilated CBD.

Adult↗

Positive intraoperative cholangiography during laparoscopic cholecystectomy: is laparoscopic common bile duct exploration necessary?

The treatment of choledocholithiasis discovered incidentally during laparoscopic cholecystectomy is not yet standardized. Options include laparoscopic common bile duct exploration (LCBDE), postoperative endoscopic retrograde cholangiopancreatography with endoscopic sphincterotomy (ERCP-ES), and no intervention. We undertook a review of our case series to determine whether LCBDE is obligatory and which LCBDE method is unsuccessful. During the 6-year study period, 91 patients with choledocholithiasis were identified. Fifty-six patients (62%) underwent LCBDE. Thirteen (23%) of these 56 patients subsequently required ERCP. Balloon sweeping of the common bile duct failed in 10 of 21 patients (48% failure) compared to any other combination of techniques with a failure rate of 1/33 (3%; P < 0.001). Two patients did not undergo complete duct exploration because of technical problems. Thirty-five patients (38%) did not undergo LCBDE. Nine of these patients (26%) did not have ERCP-ES. None of the patients who underwent postoperative ERCP-ES required additional procedures or surgery. LCBDE can successfully treat common bile duct stones, with minimal to no morbidity, but is not mandatory for safely treating choledocholithiasis. Additionally, advanced techniques for clearing the common bile duct are more successful. Surgeons should be proficient at performing these techniques.

Adult↗

Preoperative evaluation of the risk of common bile duct stones.

The patient with gallstones has an unknown risk of also having choledocholithiasis. To establish this risk preoperatively, several tests were studied in 167 patients, 37 of whom had common duct stones at exploration. With no previous or current jaundice, as well as normal alkaline phosphatase levels and a duct size of less than 12 mm, there was less than a 5% risk of choledocholithiasis; elevated bilirubin and/or alkaline phosphatase levels indicated intermediate risks (33% to 66%); and a duct size of 12 mm or greater, with any combination of other factors, indicated a 90% to 100% risk of choledocholithiasis. The surgeon should be aware of these probabilities in evaluating conditions of patients with cholelithiasis.

Alkaline Phosphatase↗

Endoscopic cholangiography and stone removal prior to cholecystectomy. A more cost-effective approach than operative duct exploration?

Would economic benefit result from performing endoscopic cholangiography and removal of common bile duct stones prior to cholecystectomy in patients who are suspected preoperatively of having choledocholithiasis? In this study, 173 patients had cholecystectomy and 30 (17%) had common bile duct exploration. Records of these patients were reviewed as were those of 31 patients who had only endoscopic cholangiography and endoscopic stone removal. Cost estimates were based on local charges. Cholecystectomy with common bile duct exploration was $6730 more per patient than cholecystectomy alone. Endoscopic cholangiography and endoscopic stone removal was 87% successful in removing duct stones. Had endoscopic cholangiography and endoscopic stone removal been performed preoperatively in patients undergoing cholecystectomy who had suspected choledocholithiasis, 21 of 30 common bile duct explorations could theoretically have been eliminated. This would have saved $85,526 or $2851 per patient undergoing common bile duct exploration. Our analysis suggests that patients who require cholecystectomy and have suspected choledocholithiasis may be treated more cost-effectively by performing endoscopic cholangiography and endoscopic stone removal immediately prior to cholecystectomy than by cholecystectomy and operative common bile duct exploration.

Adolescent↗

Endoscopic sphincterotomy: indications and results.

Endoscopic sphincterotomy (ES) is a simple, effective and remarkably safe method of treatment of choledocholithiasis and papillary stenosis. In this series, ES was technically successful in 255 (86.1 per cent) of 296 patients in whom it was attempted. Forty-nine of the successful cases had papillary stenosis complicated by pain, cholangitis and/or jaundice in patients after cholecystectomy; 205 had choledocholithiasis, of whom 164 had a cholecystectomy and 41 were poor surgical risks and did not have cholecystectomy. One patient had a tumour of the ampulla of Vater. ES has been performed as an emergency in 16 subjects because of severe septic cholangitis in 11 and acute biliary pancreatitis in 5. Of the 205 patients with choledocholithiasis, spontaneous passage of calculi after ES occurred in 151 cases (73.6 per cent), and instrumental extraction of stones was possible in 44 (21.5 per cent); 10 patients (4.9 per cent) had residual stones and required surgery. In this series the overall success rate of ES in removing common bile duct stones was 82 per cent in 238 cases; in the patients with benign papillary stenosis ES was successful in relieving symptoms and biochemical cholestasis in 72 per cent of 57 cases. Complications occurred in 18 cases (7 per cent): cholangitis in 4 (1.6 per cent) and haemorrhage in 14 (5.4 per cent). Two patients (0.8 per cent) with acute bleeding following ES died; in one of these surgery had been performed to arrest the haemorrhage, but the patient died 3 days after operation of hepatorenal failure. The other complications were treated conservatively without mortality.

Adult↗

Biliary lithiasis in the over seventy-five age group: a new therapeutic strategy.

Sixty-four gallstone patients aged 75 or more (mean age 83 +/- 5.1 years) were divided prospectively into two groups. They were mostly high-risk patients (average number of major risk factors, 2.2 +/- 0.9). Thirty-three showed one or several signs of lithiasis of the common bile duct and were treated with endoscopic sphincterotomy (ES) (31 successful cases, two technical problems) followed by early cholecystectomy (33 cases). Choledocholithiasis was present in 26 cases and stones were extracted in 25 cases. Two patients (6 per cent) died. ES caused no complications. Thirty-one other patients showed no sign of choledocholithiasis and were treated by cholecystectomy with operative cholangiography. Choledocholithiasis was found in two of these patients and treated by extraction and external drainage. Five of these patients (16 per cent) died. In 30 cases acute cholecystitis was found at operation, 15 in each group. ES is therefore an efficient procedure in high-risk patients, which facilitates operation, especially in cases of acute cholecystitis, and it is recommended in all cases of complicated biliary lithiasis. Early cholecystectomy is justified for these patients by the high frequency of associated acute cholecystitis.

Aged↗

Operative common bile duct imaging by operative cholangiography and flexible choledochoscopy.

A consecutive series of 108 common bile duct (CBD) explorations was studied to examine the efficacy of routine operative cholangiography and flexible choledochoscopy in the identification of choledocholithiasis. CBD exploration was performed according to the findings of routine operative cholangiography. Nine negative explorations were performed, only one of which would have been avoided had selective cholangiography been employed. Eight patients had unsuspected choledocholithiasis that would have been missed if selective operative cholangiography had been used. Flexible choledochoscopy identified CBD stones on 97 occasions; no additional retained stones were found on subsequent T tube cholangiography. In two cases stones were seen but could not be removed; immediate identification allowed planning for early removal. Flexible choledochoscopy is the most effective method of CBD exploration and should be used in all patients with suspected choledocholithiasis.

Adult↗

A comparison of intraoperative ultrasound versus cholangiography in the evaluation of the common bile duct during laparoscopic cholecystectomy.

Indications for intraoperative evaluation of the common bile duct during laparoscopic cholecystectomy are controversial, as is the goal of either anatomic definition or assessing for choledocholithiasis. One hundred twenty-five consecutive patients undergoing laparoscopic cholecystectomy underwent both intraoperative ultrasound and intraoperative cholangiography. Cholangiography required slightly more time to perform; it was more sensitive (92.8% vs 71.4%) but less specific (76.2% vs 100%) for choledocholithiasis than was ultrasound. Ultrasound was somewhat more difficult to perform, and, particularly in the setting of intraabdominal obesity, was often inadequate at providing clear visualization of the intrapancreatic common bile duct. It did not provide the same anatomic definition as an adequate cholangiogram. The overall incidence of choledocholithiasis was 11.2%.

Cholangiography↗

Intravenous cholangiography, ERCP, and selective operative cholangiography in the performance of laparoscopic cholecystectomy.

Between March 1990 and March 1993 some 822 consecutive patients underwent an attempt at laparoscopic cholecystectomy. Intravenous cholangiography (IVC), ERCP, and selective intraoperative cholangiography (IOC) were used in the evaluation of common bile duct (CBD) stones. Two hundred thirteen patients (26%) were identified preoperatively with either abnormal liver functions or a dilated common bile duct suggestive of CBD stones. IVC was performed in 143 patients (67%). Choledocholithiasis was identified in 14 patients (10%). Preoperative therapeutic ERCP was successful in all 14 patients (100%). Diagnostic ERCP was attempted in 61 patients and successful in 59 (97%). Choledocholithiasis was identified in 25 patients (41%). Successful extraction was accomplished in 23 patients (92%). Transcystic common bile duct exploration was used effectively in the patients with an unsuccessful ERCP. IOC was attempted in 50 patients and successful in 48 (96%). Choledocholithiasis was identified in three (6%). A retained CBD stone was present in eight patients (1%). There was one level I CBD injury (0.122%). The use of IVC, selective ERCP, and selective IOC is a reasonable approach in the performance of laparoscopic cholecystectomy.

Cholangiography↗

[Therapeutic endoscopic retrograde cholangiography (author's transl)].

Endoscopic papillotomy is a further development of endoscopic cholangiography. This therapeutic procedure was successful in 516 (94.7%) of 545 cases. Choledocholithiasis (405 cases) and papillary stenosis (97) were the main indications for the procedure. Of 405 patients with choledocholithiasis, 376 (93%) are now free of stones. There were 38 (7.4%) complications and 5 (1%) of these had a lethal outcome with (11) (2%) requiring emergency laparotomy. Cholangitis was the most serious complication. It is becoming increasingly evident that the endoscopic papillotomy is replacing reoperation in many cases of choledocholithiasis.

Cholangiography↗

Identification of carcinoembryonic antigen (CEA) in bile of patients with malignant biliary tract disease.

As a diagnostic aid of malignant hepato-biliary tract disease, carcinoembryonic antigen (CEA) levels in the bile and serum were evaluated in 12 patients with benign and 19 patients with malignant hepato-biliary diseases. Of the 12 patients with benign disease, 3 had a residual choledocholithiasis. CEA levels were determined in 7 patients with cancer of the head of pancreas or of the duodenal ampulla. Bile samples were obtained via biliary tract drainage after allowing for sufficient time to exclude the effects of pre-existing bile stasis or inflammation. The average serum CEA levels from 8 patients with benign disease were 1.5 +/- 0.23 ng/ml in contrast to 3.3 +/- 0.55 ng/ml in 18 with a malignancy (p less than 0.05). The average CEA levels in bile from 9 patients with benign and 19 with a malignancy were 1.7 +/- 0.31 ng/ml and 7.6 +/- 1.70 ng/ml respectively (p less than 0.01). In 3 with residual choledocholithiasis, serum and bile CEA levels were 2.0 +/- 0.46 ng/ml and 13.1 +/- 6.47 ng/ml. The serum and bile CEA levels from 7 patients with cancer of the head of the pancreas or of duodenal ampulla were 2.5 +/- 0.32 ng/ml and 8.8 +/- 3.3 ng/ml, respectively. Although measurement of both serum and bile CEA levels in patients with hepato-biliary tract disease proved to be useful for differentiation of malignant from benign disease, the high value obtained strongly suggests the presence of a malignancy in addition to the residual choledocholithiasis and cancer of the head of the pancreas or of the duodenal ampulla.

Adult↗

Laparoscopic common bile duct exploration.

Laparoscopic cholecystectomy has become the procedure of choice for laparoscopically skilled surgeons when dealing with both chronic and acute cholecystitis. When choledocholithiasis is encountered in the treatment of these patients the skilled laparoscopist has several treatment options available to treat the patient in one stage and avoid the morbidity of endoscopic sphincterotomy. Although still controversial, laparoscopic common bile duct exploration has been shown to be safe, applicable, and cost-effective in the treatment of choledocholithiasis. This report details several laparoscopic treatment alternatives for choledocholithiasis.

Cholangiography↗

Routine preoperative laboratory analyses are unnecessary before elective laparoscopic cholecystectomy.

BACKGROUND: We formulated a clinical pathway (CP) for elective laparoscopic cholecystectomy (LC), which included the following preoperative evaluation: history and physical (H&P), right upper quadrant ultrasound (US), and liver function tests (LFTs). We hypothesized that routine LFTs did not alter management beyond that dictated by H&P and US, and could be excluded from the CP. METHODS: The study involved 387 consecutive patients undergoing elective LC. Abnormalities in the preoperative evaluation were compared with the finding of choledocholithiasis or other unexpected outcomes. RESULTS: In 187 (48%) patients, abnormalities were found by H&P (n = 7), US (n = 13), and LFTs (n = 177). Seven patients (2%) had documented choledocholithiasis; two had abnormal H & P; three had abnormal US; and four had abnormal LFTs. No patient with choledocholithiasis had abnormal LFTs but normal H&P and US. CONCLUSIONS: Routine LFTs before elective LC are not cost effective. Before LC H&P and US are warranted, but LFTs do not add any useful information and should not be routinely measured.

Adult↗

Endoscopic sphincterotomy prior to laparoscopic cholecystectomy for the treatment of cholelithiasis.

BACKGROUND: We performed this study to assess the outcome of endoscopic retrograde cholangiography (ERC) before laparoscopic cholecystectomy (LC) for symptomatic gallbladder and suspected duct stones. METHODS: We performed prospective study of 310 patients with symptomatic gallstones and suspected choledocholithiasis managed by preoperative ERC with endoscopic extraction (ESE) and LC. The presence of one or more of the following criteria at hospital admission led to preoperative ERC because of suspected choledocholithiasis: jaundice for more than 72 h, ultrasonography measurement of the common bile duct > 8 mm, cholestasis, and acute biliary pancreatitis. RESULTS: ERC for suspected choledocholithiasis was performed in 310 patients. The rate of successful cannulation for ERC was 96.8%. Duct stones were found in 86%. Twelve patients had impacted duct stones cleared at open common duct exploration. The failure rate of ERC was 4.5%, and the rate of unnecessary ERC was 13.5%. LC was performed in 298 of 310 patients. Morbidity rates were 2.2% and 1.5% after ESE and LC, respectively. CONCLUSION: A total of 95.5% of patients with symptomatic gallbladder and ductal stones could be successfully managed by ERC prior to LC with a low morbidity rate.

Adolescent↗

Impact of laparoscopic cholecystectomy on the management of cholelithiasis in children with sickle cell disease.

Children with sickle cell disease, well known to have a high incidence of cholelithiasis, are frequently admitted to the hospital for episodes of abdominal pain. Before the advent of laparoscopy, few children with sickle cell and cholelithiasis underwent cholecystectomy unless absolutely necessary, because of the high morbidity of an open cholecystectomy (OC). We reviewed our records of all children with sickle cell disease and cholelithiasis treated from 1985 to 1992 to investigate the impact of laparoscopic cholecystectomy (LC). During that period, 32 children underwent cholecystectomy: 10 OC and 22 LC (all since December 1990). Before December 1990, all children had either classic biliary tract symptoms or abdominal pain of unknown etiology. However, of the 22 LC children, five had asymptomatic cholelithiasis. Only three of the 32 patients had choledocholithiasis, although 30 of 32 had elevated total bilirubins. Two LC children presented with choledocholithiasis and were initially treated with endoscopic sphincterotomy and stent placement. A standard intraoperative cholangiogram (IOC) through the cystic duct was performed in all OC cases. In 19 of 22 LC cases, an IOC through the gallbladder was performed before any dissection; unsuspected choledocholithiasis was not found, but the IOC did allow visualization of the course of the cystic duct, facilitating its subsequent dissection. Total operative length was comparable between the two groups, but the LC patients' postoperative length of stay was half that of the OC patients (2.1 v 4.6 days). Postoperative complications in the OC group included three children who had severe pain, atelectasis, fever, and hypoxemia (30%).

Adolescent↗