Oct05
Posted by Dr. Ashutosh Soni on Monday, 5th October 2009
"The last 30 years has seen major developments in the management of gallstone related disease, which in the United States alone costs over 6 billion dollars per annum to treat," write Earl Jon Williams, from the British Society of Gastroenterology (BSG) and the Royal Liverpool University Hospital, Liverpool, United Kingdom, and colleagues. "As a consequence clinicians are now faced with a number of potentially valid options for managing patients with suspected CBDS. It is with this in mind that the following guidelines have been written."New imaging techniques allow accurate visualization of the biliary system without requiring duct instrumentation. These include magnetic resonance (MR) cholangiography and endoscopic ultrasound (EUS). Use of endoscopic retrograde cholangiopancreatography (ERCP) is now widespread and is considered a routine procedure. Laparoscopic cholecystectomy has largely replaced open cholecystectomy, and it is often accompanied by laparoscopic exploration of the common bile duct (LCBDE).
The BSG commissioned these guidelines, which were subsequently reviewed, revised, and endorsed by the Clinical Standards and Services Committee of the BSG, the BSG Endoscopy Committee, the ERCP stakeholder group, the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, and the Royal College of Radiologists.
After a preliminary search of the literature in 2004 of PubMed and MEDLINE, the findings were summarized and were presented to the BSG Endoscopy Committee, which developed principal clinical questions to be addressed by the guidelines. A multidisciplinary guideline-writing group then wrote provisional guidelines.
Some of the specific recommendations are as follows:
• Hepatobiliary cases should be discussed in a multidisciplinary setting (grade C).
• Symptomatic patients in whom evaluation suggests ductal stones should undergo extraction if possible (grade B).
• Transabdominal ultrasound scanning (USS) is recommended as a preliminary investigation for CBDS, but it is not a sensitive test for this condition (grade B).
• EUS and MR cholangiography are both highly effective at confirming CBDS; patient suitability, accessibility, and local expertise should help decide between the 2 procedures (grade B).
• When performing endoscopic stone extraction (ESE), the endoscopist should be assisted by a technician or radiologist who can help with fluoroscopy, a nurse for safety monitoring, and an additional endoscopy assistant or nurse to manage guide wires and other technical aspects as needed (grade C).
• ERCP should be done only in patients who are expected to require an intervention; it is not recommended for use solely as a diagnostic test (grade B).
• Full blood count and prothrombin time/international normalized ratio (PT/INR) should be performed within 72 hours before biliary sphincterotomy for ductal stones; patients with abnormal clotting should undergo subsequent management based on locally agreed guidelines (grade B).
• For patients treated with anticoagulants but who are at low risk for thromboembolism, anticoagulants should be discontinued before endoscopic stone extraction if biliary sphincterotomy is planned (grade B) as should newer antiplatelet agents (eg, clopidogrel), 7 to 10 days before biliary sphincterotomy (grade C). Use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), and low-dose heparin should not be considered a contraindication to biliary sphincterotomy (grade B).
• Patients with biliary obstruction or previous features of biliary sepsis should receive prophylactic antibiotics (grade A).
• Sphincterotomy initiated with use of pure cut may be preferred in patients with risk factors for post-ERCP pancreatitis but not biliary sphincterotomy–induced hemorrhage (grade A).
• In most patients undergoing stone extraction, balloon dilation of the papilla should be avoided because the risk for severe post-ERCP pancreatitis is increased vs biliary sphincterotomy (grade A).
• Short-term use of a biliary stent, followed by further endoscopy or surgery, is recommended to ensure adequate biliary drainage in patients with CBDS that have not been extracted (grade B).
• Use of a biliary stent as sole treatment of CBDS should be limited to patients with limited life expectancy or prohibitive surgical risk, or both (grade A).
• Pre-cut is a risk factor for complication and should be used only by those with appropriate training and experience and only in patients for whom subsequent endoscopic treatment is essential (grade B).
• Operative risk should be evaluated before scheduling intervention, and endoscopic therapy should be considered as an alternative in high-risk patients (grade B).
• Intraoperative cholangiography or laparoscopic ultrasound can detect CBDS in patients who are suitable for surgical exploration or postoperative ERCP (grade B).
• In patients undergoing laparoscopic cholecystectomy, transcystic and transductal exploration of the common bile duct are both considered appropriate for removal of CBDS (grade A).
• When minimally invasive techniques fail to achieve duct clearance, open surgical exploration is still considered to be an important treatment option (grade B).
The guidelines also discuss supplementary treatments including mechanical lithotripsy, extracorporeal shock wave lithotripsy, electrohydraulic lithotripsy and laser lithotripsy, percutaneous treatment, and oral ursodeoxycholic acid. Management of specific clinical scenarios is also presented.
"Biliary sphincterotomy and endoscopic stone extraction (ESE) is recommended as the primary form of treatment for patients with CBDS post cholecystectomy," the authors of the guidelines write. "Cholecystectomy is recommended for all patients with CBDS and symptomatic gallbladder stones, unless there are specific reasons for considering surgery inappropriate. Patients with CBDS undergoing laparoscopic cholecystectomy may be managed by laparoscopic common bile duct exploration (LCBDE) at the time of surgery, or undergo peri-operative ERCP."
Clinical Context
In the last 3 decades, major developments in the management of gallstone-related disease have extended the range of suitable options for evaluation and treatment of CBDS. The high healthcare costs associated with this condition (> 6 billion dollars per year in the United States alone) warrant new guidelines providing recommendations for clinical management.
ERCP is now widely available and is performed routinely, and laparoscopy has mostly obviated the need for open cholecystectomy. New imaging techniques facilitating less invasive visualization of the biliary tree include MR cholangiography and EUS.
Study Highlights
• Multidisciplinary management is recommended for hepatobiliary cases.
• Transabdominal USS is not a sensitive test for CBDS, but it is suitable as a preliminary investigation.
• EUS and MR cholangiography are both highly effective at confirming CBDS. Patient-specific factors, local availability, and local expertise should guide the choice between the 2 procedures.
• Symptomatic patients with suspected ductal stones based on evaluation should undergo extraction if possible.
• Biliary sphincterotomy and ESE are recommended as the primary forms of treatment of patients with CBDS postcholecystectomy.
• Unless there are specific reasons for considering surgery inappropriate, cholecystectomy is recommended for all patients with CBDS and symptomatic gallbladder stones.
• Patients with CBDS undergoing laparoscopic cholecystectomy may be treated by LCBDE at the time of surgery or undergo perioperative ERCP.
• Endoscopists performing ESE should be assisted by a technician or radiologist who can help with fluoroscopy, a nurse for safety monitoring, and an additional endoscopy assistant or nurse to manage technical aspects as needed.
• ERCP should be done only in patients who are expected to require an intervention; it is not recommended solely for diagnostic use.
• Full blood count and PT/INR should be performed within 72 hours before biliary sphincterotomy for ductal stones; patients with abnormal clotting should be treated according to local protocol.
• For patients treated with anticoagulants but at low risk for thromboembolism, anticoagulants should be discontinued before ESE if biliary sphincterotomy is planned (grade B) as should newer antiplatelet agents. Use of aspirin, NSAIDs, and low-dose heparin should not be considered a contraindication to biliary sphincterotomy.
• Antibiotic prophylaxis should be given to patients with biliary obstruction or previous features of biliary sepsis.
• Sphincterotomy initiated with use of pure cut may be preferred in patients with risk factors for post-ERCP pancreatitis but not biliary sphincterotomy–induced hemorrhage.
• Balloon dilation of the papilla should be avoided in most patients undergoing stone extraction because the risk for severe post-ERCP pancreatitis is increased vs biliary sphincterotomy.
• For CBDS that have not been extracted, short-term use of a biliary stent, followed by further endoscopy or surgery, is recommended to ensure adequate biliary drainage.
• Only patients with limited life expectancy or prohibitive surgical risk, or both, should undergo use of a biliary stent as sole treatment of CBDS.
• Pre-cut increases the risk for complication and should be used only by those with appropriate training and experience and only for patients in whom subsequent endoscopic treatment is essential.
• Operative risk should be evaluated before surgery is scheduled. In high-risk patients, endoscopic therapy should be considered as an alternative.
• In patients deemed suitable for surgical exploration or postoperative ERCP, intraoperative cholangiography, or laparoscopic ultrasound can detect CBDS.
• Transcystic and transductal exploration of the common bile duct are both considered appropriate for removal of CBDS in patients undergoing laparoscopic cholecystectomy.
• Open surgical exploration is still considered to be an important treatment option when minimally invasive techniques do not achieve duct clearance.
• Supplementary treatments may include mechanical lithotripsy, extracorporeal shock wave lithotripsy, electrohydraulic lithotripsy and laser lithotripsy, percutaneous treatment, and oral ursodeoxycholic acid.
Pearls for Practice
• Transabdominal USS is recommended as a preliminary investigation for CBDS, but it is not a sensitive test for this condition. EUS and MR cholangiography are both highly effective at confirming CBDS; patient suitability, accessibility, and local expertise should help decide between the 2 procedures.
• Biliary sphincterotomy and ESE are the primary forms of treatment recommended for patients with CBDS postcholecystectomy. For all patients with CBDS and symptomatic gallbladder stones, cholecystectomy is recommended, unless there are specific reasons for considering surgery inappropriate. Patients with CBDS undergoing laparoscopic cholecystectomy may be treated by LCBDE at the time of surgery or undergo perioperative ERCP.
Based on the BSG guidelines, which of the following statements about evaluation of CBDS is correct?
Transabdominal USS is a sensitive test for CBDS
EUS is significantly less effective than MR cholangiography for confirming CBDS
EUS is significantly more effective than MR cholangiography for confirming CBDS
Transabdominal USS is recommended as a preliminary investigation for CBDS
Based on the BSG guidelines, which of the following statements about treatment of CBDS is not correct?
Perioperative ERCP is not recommended for patients with CBDS undergoing laparoscopic cholecystectomy
Biliary sphincterotomy and ESE are recommended as the primary forms of treatment of patients with CBDS postcholecystectomy
Cholecystectomy is recommended for all patients with CBDS and symptomatic gallbladder stones, unless they are not surgical candidates
Patients with CBDS undergoing laparoscopic cholecystectomy may be treated by LCBDE at the time of surgery