The Tokyo Guidelines of 2007 (TG07) described the techniques and recommendations of biliary decompression in patients with acute cholangitis. TG07 recommended that endoscopic transpapillary biliary drainage should be selected as a first-choice therapy for acute cholangitis because it is associated with a low mortality rate and shorter duration of hospitalization. However, TG07 did not include the whole technique of standard endoscopic transpapillary biliary drainage, for example, biliary cannulation techniques including contrast medium-assisted cannulation, wire-guided cannulation, and treatment of duodenal major papilla using endoscopic papillary balloon dilation (EPBD). Furthermore, recently single- or double-balloon enteroscopy-assisted biliary drainage (BE-BD) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) have been reported as special techniques for biliary drainage. Nevertheless, the updated Tokyo Guidelines (TG13) recommends that endoscopic drainage should be first-choice treatment for biliary decompression in patients with non-surgically altered anatomy and suggests that the choice of cannulation technique or drainage method (endoscopic naso-biliary drainage and stenting) depends on the endoscopist’s preference but EST should be selected rather than EPBD from the aspect of procedure-related complications. In terms of BE-BD and EUS-BD, although there are many reports on the their usefulness, they should be performed by skilled endoscopists in high-volume institutes, who are good at enteroscopy or echoendosonography, respectively, because procedures and devices are not yet established.
Free full-text articles and a mobile application of TG13 are available via http://www.jshbps.jp/en/guideline/tg13.html.
Acute cholangitis varies in severity, ranging from a mild form which can be treated by conservative therapy to a severe form which leads to a life-threatening state, e.g. shock state and altered sensorium. In particular, the severe form often results in mortality in the elderly [1–3]. Biliary drainage, which is the most essential therapy for acute cholangitis, is divided into three types, surgical, percutaneous transhepatic, and endoscopic drainage. Of these therapies, it is well known that surgical intervention leads to the highest mortality rate . Recently, mortality due to acute cholangitis has decreased due to development of percutaneous transhepatic cholangial drainage (PTCD)  and endoscopic biliary drainage [5, 6]. Nevertheless, acute cholangitis can still be fatal unless it is treated in a timely way. The Tokyo Guidelines of 2007 (TG07) described the fundamental biliary drainage techniques for acute cholangitis . Subsequently, new biliary drainage techniques for the therapy of acute cholangitis have been reported. Herein, we describe the indications and techniques of biliary drainage for acute cholangitis in the updated Tokyo Guidelines (TG13).
Indications and techniques of biliary drainage
In TG13, biliary drainage is recommended for acute cholangitis regardless of degree of severity other than some cases of mild acute cholangitis in which antibiotics and general supportive care are effective.
Q1. What is the most preferable biliary drainage? endoscopic vs percutaneous vs surgical drainage for acute cholangitis?
Percutaneous transhepatic cholangial drainage (supplement video 1)
Nowadays, percutaneous transhepatic cholangial drainage (PTCD), also known as percutaneous transhepatic biliary drainage (PTBD), has become the second choice of therapy for acute cholangitis following endoscopic drainage because of possible complications, including intraperitoneal hemorrhage and biliary peritonitis, and the need for a long hospital stay. However, PTCD can still be conducted in any of the following circumstances: (1) in patients with an inaccessible papilla due to upper GI tract obstruction, as in duodenal obstruction or surgically altered anatomy like Whipple resection or Roux-en-Y anastomosis, in which the passage of endoscope or endoscopic drainage is thought to be difficult or impossible; (2) when skilled pancreaticobiliary endoscopists are not available in the institution. Furthermore, even in patients with non-surgically altered anatomy, PTCD can be salvage therapy when conventional endoscopic drainage has failed. In general, coagulopathy is a relative contraindication. However, if there is no other life-saving method, PTCD would be indicated.
Before the prevalence of transabdominal ultrasonography, needle puncture of the bile duct was conducted under fluoroscopy . Currently, needle puncture is safely performed under ultrasonography to avoid the intervening blood vessel . Therefore, in the current PTCD procedure, operators should continuously observe the bile duct using ultrasonography regardless of the presence of dilation. The PTCD procedure is performed as follows, and as previously described . Briefly, at first, ultrasonography-guided transhepatic puncture of the intrahepatic bile duct is conducted using an 18- to 22-G needle. After confirming backflow of bile, a guidewire is advanced into the bile duct. Finally, a 7- to 10-Fr catheter is placed in the bile duct under fluoroscopic control over the guidewire. Puncture using a small-gauge (22-G) needle is safer in patients without biliary dilation than with biliary dilation. According to the Quality Improvement Guidelines produced by American radiologists, the success rates of drainage are 86 % in patients with biliary dilation and 63 % in those without biliary dilation .
In benign diseases like bile duct stones, surgical drainage is extremely rare because of the prevalence of endoscopic drainage or PTCD for the therapy of acute cholangitis. However, in patients with acute cholangitis due to unresectable neoplasms like cancer of the pancreatic head, hepaticojejunostomy can be performed as bypass surgery only in limited patients without severe acute cholangitis. In particular, when periampullary neoplastic lesions like cancer of the pancreatic head or ampullary cancer, show both acute cholangitis and duodenal obstruction, double bypass surgery, hepaticojejunostomy and gastrojejunostomy, may be a rare choice.
Open drainage for decompression of the bile duct is performed as a surgical intervention. When surgical drainage in critically ill patients with bile duct stones is performed, prolonged operations should be avoided and simple procedures, such as T-tube placement without choledocholithotomy, are recommended .
Endoscopic biliary drainage
Endoscopic transpapillary biliary drainage has become the gold standard technique for acute cholangitis, regardless of whether the pathology is benign or malignant, because it is a minimally invasive drainage method . On the other hand, endoscopic drainage using a standard duodenoscope in patients with duodenal obstruction and surgically altered anatomy, like Roux-en-Y anastomosis, seems to be contraindicated.
The timing of endoscopic biliary drainage is very important for the clinical outcome. Khashab et al.  described that delayed (more than 72 h after administration) and unsuccessful ERCP are associated with worse outcomes in patients with acute cholangitis. Actually, in TG07, two thirds of outstanding pancreatobiliary surgeons and endoscopists supported the use of emergent or early drainage in patients with moderate or severe cholangitis .
Biliary cannulation should be conducted in advance of biliary drainage. Basically, there are two biliary cannulation techniques, namely contrast medium-guided cannulation (standard cannulation) and wire-guided cannulation.
Q2. What technique should be used for biliary cannulation? Standard cannulation or wire-guided cannulation?
Two meta-analyses of a randomized controlled trial (RCT) on the comparison between standard cannulation and wire-guided cannulation showed that wire-guided cannulation was able to increase the successful biliary cannulation rate and prevent post-ERCP pancreatitis [16, 17]. Recently, however, two RCTs have shown that there is no statistically significant difference between standard cannulation and wire-guided cannulation on the success rate of biliary cannulation or the prevention rate of post-ERCP pancreatitis [18, 19]. Therefore, the choice of techniques for biliary cannulation is still controversial.
When biliary cannulation using standard cannulation or wire-guided cannulation techniques fails, precutting, which means an incision of the papilla enabling the bile duct orifice to be opened for biliary cannulation, may be performed if an alternative method, like PTCD or surgical intervention, is not performed. In the main, two types of precutting methods are used. Needle knife precutting using needle-type sphincterotome is well known as a basic precutting method (Fig. 1a). Alternatively, several endoscopists prefer pancreatic sphincter precutting using a pull-type sphincterotome for biliary access (Fig. 1b). The use of precutting methods depends on the institution and endoscopist. It is known that precutting is likely to cause serious complications, such as acute pancreatitis and perforation, and therefore it should be performed only by skilled endoscopists [20, 21].
Endoscopic naso-biliary drainage and endoscopic biliary stenting
Endoscopic transpapillary biliary drainage is divided into two types: endoscopic naso-biliary drainage (ENBD) as an external drainage and endoscopic biliary stenting (EBS) as an internal drainage. Although, basically, both endoscopic biliary drainage types can be conducted in all acute cholangitis, they may be contraindicated in patients in whom the endoscope cannot reach the papilla due to GI tract obstruction or surgically altered anatomy, or in whom endoscopic procedures are inadequate because of critical illness. In particular, ENBD should be avoided in patients with poor compliance, who may remove the tube, and those with abnormalities of the nasal cavity causing difficulty in naso-biliary tube insertion.
In the case of biliary drainage for therapy of acute cholangitis, skillful endoscopic technique is mandatory because long and unsuccessful procedures may lead to serious complications in critical ill patients. Therefore, endoscopists who perform endoscopic biliary drainage in these patients, should already have a high success rate of biliary cannulation including the precutting technique.
Q3. What procedure should be used for endoscopic biliary drainage? ENBD or EBS?
Three comparative studies have shown that there is no statistically significant difference in technical success, clinical success, complications and mortality between ENBD and EBS, although a visual analogue scale was higher in the ENBD group than in the EBS group (Table 1) [22–24]. In consequence of these results, TG13 suggests that either drainage procedure can be selected according to the preference of the endoscopist. However, if ENBD is selected for the treatment of acute cholangitis, we should bear in mind that if the patient has discomfort from the transnasal tube placement, they are likely to remove the tube themselves, especially elderly patients.
One RCT has revealed that biliary drainage is not mandatory after endoscopic clearance of the common bile duct in patients with choledocholithiasis-induced cholangitis (level B) .
ENBD (supplement video 2)
EBS (supplement video 3)
EBS procedures is also described in the previous guideline . In brief, after selective biliary cannulation, a 7- to 10-Fr plastic stent is placed in the bile duct as an internal drainage over the guidewire. There are two different stent shapes, a straight type with a single flap with a sidehole (Amsterdam type) (Fig. 2b) or radial flaps without a sidehole (Tannenbaum type) on both sides, and a double pig-tail type to prevent inward and outward stent migration. There is no comparative study between straight type and pig-tail type stents. Therefore, either stent can be selected according to the preference of the endoscopist.
Treatment of the major papilla
Endoscopic sphincterotomy (EST)
EST technique is usually used for stone removal and, at times, prevention of the occlusion of the pancreatic duct orifice by placement of a large-bore biliary stent (more than 10-Fr or a self-expandable metal stent).
Q4. Is EST necessary in endoscopic biliary drainage?
As TG07 described, an additional EST is not necessary in acute cholangitis as follows: (1) additional EST causes complications such as hemorrhage [26, 27]; (2) post-EST hemorrhage is one of the risk factors of acute cholangitis . In particular, the use of EST in patients with severe (grade III) disease complicated by coagulopathy should be avoided. Nevertheless, EST has some advantages as follows: (1) it provides not only drainage but also clearance of bile duct stones at a single session in patients with choledocholithiasis (not complicated by severe cholangitis). (2) Precutting can allow bile duct access, providing biliary drainage in patients in whom selective biliary cannulation is impossible using the standard cannulation technique. In particular, stone removal in one session can shorten the hospital stay. Therefore, TG13 suggests that addition of EST should be determined according to the patient’s condition and the operator’s skill.
The detail of EST procedures is described in TG07 . Briefly, after selective biliary cannulation with or without a guidewire, a pull-type sphincterotomy incision is performed below the transverse fold (Fig. 3). When the transverse fold is not present, the superior margin of the papilla bulge is used as a landmark to determine the length of the sphincterotomy (supplement video 4). An electrosurgical generator with a controlled cutting system (Endocut mode, ICC200, VIO300, ERBE Elektromedizin GmbH, Tubingen, Germany) is used for EST; the push-type is used for EST in patients with Billroth II gastrectomy or Roux-en-Y anastomosis. Only a limited incision is necessary in EST for drainage purposes using a large-bore stent, unlike that for stone removal . Endoscopists should remember that EST may cause acute pancreatitis or cholangitis, which may become life-threatening when severe .
Endoscopic papillary balloon dilation (EPBD)
The EPBD procedure is usually used instead of EST for removal of bile duct stones . Until now, there has been no comparative study on the use of EPBD during biliary drainage to treat acute cholangitis due to bile duct stones. EPBD, like EST, has the advantage of reducing the number of therapeutic sessions and shortening the hospital stay in patients with acute cholangitis caused by bile duct stones. One systematic review revealed that EPBD is statistically less successful for stone removal, requires higher rates of mechanical lithotripsy, and carries a higher risk of pancreatitis, although it also has statistically significant lower rates of bleeding . Thus, TG13 suggests that EPBD appears to be useful for treatment in patients who have coagulopathy and acute cholangitis caused by a small stone.
On the other hand, theoretically, since the aim of EPBD is to preserve the function of the sphincter of Oddi, EPBD alone without biliary drainage is contraindicated for the therapy of acute cholangitis. In addition, EPBD should be avoided in patients with biliary pancreatitis.
After selective biliary cannulation, a small balloon up to 8-mm in diameter, depending on the diameters of the bile duct and the stone, is advanced into the bile duct across the papilla. Then, the sphincter of Oddi is gradually dilated by inflation of the balloon until the waist of the balloon disappears. Then, clearance of the bile duct stone is conducted using a basket catheter and balloon catheter.
Special techniques of endoscopic biliary drainage
Recently, several new techniques of endoscopic biliary drainage have been developed.
Balloon enteroscope-assisted bile duct drainage
ERCP in patients with surgically altered anatomy can be challenging. In general, Roux-en-Y anastomosis has been thought to preclude endoscopic access for ERCP because of the extensive lengths of the efferent and afferent limbs that must be traversed to reach the major papilla or hepaticojejunostomy site. Recently, single balloon enteroscopy (SBE) and double balloon enteroscopy (DBE) have enabled successful ERCP to be performed in patients with such surgically altered anatomy. Several investigators have reported various success rates (40 to 95 %) with adverse events rates below 5 % (Tables 2, 3) [30–42]. However, since this technique may be unsuccessful and time-consuming, its indication should be cautiously decided. Although ideal operators are those who are skilled in both balloon enteroscopy and ERCP, in some institutions, GI endoscopists advance an endoscope to the papilla or anastomotic site and then pancreaticobiliary endoscopists perform ERCP. Therefore, if the operators are not good at this technique, therapy using balloon enteroscopy should be avoided.
Techniques (supplement video 5)
The SBE and DBE balloon system consists of a video enteroscope (XSIF-Q260Y; Olympus Medical Systems, Tokyo, Japan and long-type DBE: EN-450T5, short-type DBE: EC-450B15/EI-530B, Fujifilm Co., Ltd., Saitama, Japan), a sliding tube with a balloon and a balloon controller. The DBE has a balloon at the tip of the endoscope in addition to the balloon of the overtube. Endoscopes are advanced to the papilla or anastomotic site using the pushing and pulling techniques (Fig. 4a, b). An injection catheter and a tapered catheter are used for initial cannulation. First, 0.025–0.035-inch guidewires are inserted into the bile duct. Finally, 5–8.5-Fr naso-biliary drainage catheters and self-expandable metallic stents are placed into the bile duct for biliary decompression. In cases requiring an endoscopic sphincterotomy, a sphincterotome and needle knife are advanced into the bile duct over or alongside the guidewire. In cases of EPBD, a conventional dilation catheter is used for the papilla or hepaticojejunostomy site. When selective cannulation is not possible, a needle knife is used for pre-cutting. A basket catheter, retrieval balloon catheter, and/or mechanical lithotriptor are used for removal of stones.
Endoscopic ultrasonography-guided bile duct drainage
Recently, endoscopic ultrasonography (EUS)-guided biliary drainage has been reported as a salvage therapy when standard endoscopic drainage has failed [43–54]. Since the technique and devices of this procedure are not yet established and there is no dedicated device for this procedure, it should be conducted only in selected patients in whom standard biliary drainage by means of ERCP or PTCD has failed or is contraindicated for various reasons like considerable ascites. There are two methods of approach in EUS-guided biliary drainage: (1) EUS-guided intrahepatic bile duct drainage (Fig. 5a) by a transesophageal, transgastric or transjejunal approach; (2) EUS-guided extrahepatic bile duct drainage (Fig. 5b) by a transduodenal or transgastric approach. The choice of drainage route depends on the presence of a gastric outlet obstruction and the stricture site of the bile duct. Several published data on EUS-guided intrahepatic bile duct drainage and extrahepatic bile duct drainage show that the success rate is high (95 %), with 93–100 % (intention-to-treat) response rates (Table 4) [43–54]. Most of the reported cases of adverse events were pneumoperitonitis but there was no serious adverse event. However, since the procedure is not yet established, it should be conducted by endoscopists skilled in both echoendosonography and ERCP.
Techniques  (supplement video 6 and video 7)
Theoretically, the intrahepatic bile duct and liver, including the extrahepatic bile duct does not adhere to the GI tract. Therefore, there is a possibility of bile leakage during the procedure; particularly, if the procedure fails, serious bile peritonitis can occur. A needle knife (Zimmon papillotomy knife, or Cystotome, Wilson-Cook, Winston-Salem, NC) catheter using electrocautery (EndoCut ICC200, VIO300D, ERBE Elektromedizin GmbH, Tübingen, Germany), or a 19-gauge needle (EchoTip, Wilson-Cook), is advanced into the bile duct under EUS visualization after confirming the absence of intervening blood vessels to avoid bleeding. After the stylet is removed, bile is aspirated and then contrast medium is injected into the gallbladder for cholecystography, then a 450 cm long, 0.025- or 0.035-inch guidewire is advanced into the outer sheath. If necessary, a biliary catheter for dilation (Soehendra Biliary Dilator, Wilson-Cook), papillary balloon dilation catheter (Maxpass, Olympus Medical Systems), and electrical cautery needle, are used for dilation of the hepaticoenterostomy site and choledochoenterostomy site. Finally, a 7-Fr plastic stent or a self-expandable metal stent are advanced into the bile duct.
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We are indebted to Professor J. Patrick Barron, Chairman of the Department of International Medical Communications at Tokyo Medical University, for his editorial review of the English manuscript.
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Itoi, T., Tsuyuguchi, T., Takada, T. et al. TG13 indications and techniques for biliary drainage in acute cholangitis (with videos). J Hepatobiliary Pancreat Sci 20, 71–80 (2013). https://doi.org/10.1007/s00534-012-0569-8
- Percutaneous biliary drainage
- Endoscopic biliary drainage
- Endoscopic cholangio-pancreatography