BILIARY CANNULATION FOR the treatment of biliary

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1 Digestive Endoscopy 2016; 28 (Suppl. 1): doi: /den Current situation of cannulation and salvage for difficult cases Endoscopic ultrasonography-guided rendezvous technique Takayoshi Tsuchiya,* Takao Itoi, Atsushi Sofuni, Ryosuke Tonozuka and Shuntaro Mukai Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan Endoscopic retrograde cholangiopancreatography (ERCP) requires deep biliary cannulation. When deep biliary cannulation is failed, the endoscopic ultrasonography rendezvous technique (EUS-RV) is a useful salvage method. From the previous 15 articles that included 382 EUS-RV cases, the overall success rate of EUS-RV is 81 % with a complication rate of 10 %. In EUS-RV, the bile duct is punctured under EUS guidance and a guidewire is advanced into the duodenum via the papilla. The EUS scope is then switched to a duodenoscope and inserted into the bile duct over the guidewire exiting the papilla, or the guidewire is grasped with forceps and passed through the working channel; the catheter can then be inserted through the papilla over the wire. There are three puncture routes for EUS-RV: transgastric puncture of the intrahepatic bile duct (IHBD), transduodenal puncture of the extrahepatic bile duct (EHBD) via the proximal duodenum (D1), and transduodenal puncture of the EHBD via the second portion of the duodenum (D2). The puncture route for each patient should be selected based on the patient condition. GW selection for EUS-RV is critical, a hydrophilic GW is useful for this procedure. Although EUS-RV is now performed relatively routinely in a few high-volume centers, procedure standardization and the development of exclusive devices for EUS-RV are still underway. The development of exclusive devices for EUS-RV and prospective comparative studies with other salvage methods are needed to truly evaluate the procedure s usefulness and safety. Key words: endoscopic ultrasonography (EUS), EUS-guided biliary drainage (EUS-BD), EUS-guided choledochoduodenostomy (EUS- CDS), EUS-guided hepaticogastrostomy (EUS-HGS), EUS-guided rendezvous technique INTRODUCTION BILIARY CANNULATION FOR the treatment of biliary diseases is required in procedures related to endoscopic retrograde cholangiopancreatography (ERCP); however, 100% biliary cannulation cannot be achieved even by skilled pancreatobiliary endoscopists. In cases of biliary cannulation difficulty to date, the precut, double guidewire, and rendezvous (by via the percutaneous route) techniques have been used. 1 4 With the recent advance in endoscopic ultrasonography (EUS) technology, the usefulness of the EUS rendezvous technique (EUS-RV) has been reported, where the bile duct is punctured under the EUS guidance and a guidewire is advanced antegrade through the papilla to perform a transpapillary procedure. 5 7 The first EUS-RV report was by Mallery et al. 8 in 2004; EUS-guided rendezvous drainage of the obstructed biliary and pancreatic ducts was performed in patients with ERCP failure as well as those with pancreatic drainage. Many reports followed, making the procedure widely recognized. Although Corresponding: Takayoshi Tsuchiya, Department of Gastroenterology and Hepatology, Tokyo Medical University Nishishinjuku, Shinjuku-ku, Tokyo , Japan tsuchiya@tokyo-med.ac.jp Received 30 November 2015; accepted 17 January EUS-RV is now performed relatively routinely in a few highvolume centers, the standardization of procedures and the development of exclusive devices for EUS-RV remain underway; therefore, the procedure is not yet widely used. A prospective comparative trial is required to demonstrate its true usefulness and rate of procedural accidents, while the development of exclusive devices for interventional EUS is needed. In this review article, we describe the details of the procedure based on previous reports. TECHNIQUES Patient selection WE SHOWS OUR strategy of difficult biliary cannulation in Figure 1. EUS-RV is actually indicated for patients in whom even skilled endoscopists had difficulty performing biliary cannulation. Difficult biliary cannulation was defined as biliary cannulation that could not be achieved even with the use of advanced techniques such as double guidewire method, precut (pancreatic sphincter precut, needle knife precut), or accomplishing biliary cannulation was judged to be difficult by the operator such as tumor invasion of papilla or location of papilla (e.g. diverticulum, D3 open). Meanwhile, it is contraindicated for patients with a intervening bs_bs_banner 96

2 Digestive Endoscopy 2016; 28 (Suppl. 1): EUS-guided rendezvous technique 97 Figure 1 Our strategy of biliary cannulation for difficult cases. blood vessel in the puncture route of the gastrointestinal tract and the bile duct; patients with no visible bile duct, the puncture target, on imaging; patients with insufficient dilatation; and patient with coagulopathy and intake of anticoagulant or antiplatelet agents. Moreover, since the incidence of bile leakage as a procedural complication is not small in patients with critical ill condition, it is also necessary to fully recognize the possibility of death by biliary or bacterial peritonitis before the onset of drainage efficacy. Sufficient informed consent should be obtained to educate patients about the possibility of procedural adverse events and need for emergency surgery. Figure 2 Transgastric puncture of the intrahepatic bile duct (B2). EUS-RV puncture route There are three puncture routes for EUS-RV. The first route is transmural puncture of the intrahepatic bile duct (IHBD) as the IHBD route (Fig. 2). For the IHBD puncture route, transesophageal puncture of B2 and transgastric puncture of B2 or B3 can be performed; in addition, transjejunal puncture is possible in patients who underwent reconstruction after total gastrectomy. However, a transgastric puncture route especially B2 is selected in many patients. There are two methods of transduodenal puncture of the extrahepatic bile duct (EHBD): EHBD puncture via the proximal duodenum (D1) and EHBD puncture via the second portion of the duodenum (D2). In the EHBD puncture via D1, the scope is in a push position (long position) (Fig. 3), whereas it is in a short position via D2. When performing the EHBD puncture via the duodenum is difficult, the antrum of the stomach is rarely punctured (Fig. 4). Figure 3 Extrahepatic bile duct (EHBD) puncture via D1, the scope is in a push position(long position). Actual technique The procedure uses a linear array echoendoscope. Although small-diameter linear array echoendoscope have become available in recent years, therapeutic echoendoscopes with large working channel are recommend. After the bile duct to

3 98 T. Tsuchiya et al. Digestive Endoscopy 2016; 28 (Suppl. 1): Figure 4 Extrahepatic bile duct (EHBD) puncture via stomach, the scope is in a shortposition. be punctured is visualized using EUS, the presence or absence of blood vessels in the puncture route is confirmed using color Doppler imaging (Fig. 5a). Scope location is confirmed fluoroscopically. When scope stability is poor, the scope is held by an assistant at the puncture position. In the next procedure, 19G puncture needles are primarily used. This is because a or inch guidewire can be used. When bile duct dilatation is insufficient, it is possible to use a or inch guidewire with a 22G needle; however, it is prone to kinking. Therefore, it is sometimes useful to perform a re-puncture with a 19G needle by fully dilating the bile duct using contrast imaging. It is also better to withdraw the stylet of the needle and fill the needle with contrast medium. After the puncture, the bile duct s course and location are confirmed by contrast imaging (Fig. 5b). At that time, the use of thick contrast medium makes it difficult to see the guidewire and devices behind it; therefore, contrast medium should be diluted or switched to saline after a certain amount of contrast medium is injected. After contrast imaging, the guidewire is sufficiently advanced into the duodenum via the stenosis site and the papilla (Fig. 5c), while the EUS scope is switched to a dudenoscope. A hydrophilic guidewire is useful for this procedure. Biliary cannulation is performed over the guidewire coming out of the papilla, or the guidewire is grasped with snare or biopsy forceps (Fig. 5d) and passed through the accessory channel, and the ERCP catheter is then advanced into the bile duct over the guidewire (Fig. 5e). Figure 5 Endoscopic ultrasonography guided rendezvous technique (EUS-RV) for thefailed biliary cannulation (transgastric route). a.) Absence of blood vessels in the puncture route is confirmed using color Doppler imaging, b.) puncture the intrahepatic bile duct (B2) using 19 G needle andcholangiography was obtained, c.) insertion of hydrophilic guide wire into the duodenum via the stricture andpapilla, d.) EUS scope is switched to a duodenal scope, and the guidewire is graspedwith biopsy forceps, e.) ERCP catheter is advanced into the bile duct over the guidewire. Literature review Published EUS-RV data are shown in Table 1. 5,6,9 21 We reviewed 15 published articles that included 382 cases. The overall success rate of EUS-RV is 81 % with a complication rate of 10 %. The success rates by the puncture route were 65% for the IHBD puncture route and 87% for the EHBD puncture route. The major complications were bleeding, bile leakage, peritonitis, pneumoperitoneum, and pancreatitis. The incidences

4 Digestive Endoscopy 2016; 28 (Suppl. 1): EUS-guided rendezvous technique 99 Table 1 Published data on EUS-guided rendezvous technique References Years No. of cases EHBD approach success %(n) IHBD approach success % (n) Overall success % (n) Complication rate % (n) Complication (no. of cases) Kahaleh et al (7/10) 85 (11/13) 78 (18/23) 17 (4/23) Bleeding(1), bile leak(1), pneumoperitoneum(2) Tarantino et al (4/8) - 50 (4/8) 13 (1/8) Death due to LC(1) Maranki et al (8/14) 69 (24/35) 65 (32/49) 16 (8/49) Bleeding(1), peritonitis(1), pneumoperitoneum(4), pneumonia(1), abdominal pain(1) Brauer et al (7/12) - 58 (7/12) 17 (2/12) Pneumoperitoneum(1), respiratory failure(1) Kim et al (12/15) - 80 (12/15) 13 (2/15) Sepsis(1), pancreatitis(1) Iwashita et al (25/31) 44 (4/9) 73 (29/40) 13 (5/40) Abdominal pain(1), pancreatitis(2) pneumoperitoneum(1), sepsis/death(1) Shah et al NA NA # 75 (37/50) 8 (4/50) Pancreatitis(2), bile leak(1), perforateon(1) Dhir et al (57/58) - 98 (57/58) 3 (2/58) Extravasation of contrast(2) Kawakubo et al (9/9) 100 (5/5) 100 (14/14) 14 (2/14) Pancreatitis(1), peritonitis(1) Park et al (13/14) 50 (3/6) 80 (16/20) 10 (2/20) Pancreatitis(1), peritonitis(1) Khashab et al (11/11) 100 (2/2) 100 (13/13) 15 (2/13) Pancreatitis(1), cholecystitis(1) Dhir et al (18/18) 94 (16/17) 97 (34/35) 23 (8/35) Abdominal pain(8 $ ), bile leak(2), pneumoperitoneum(2) Dhir et al NA NA 100 (20/20) 15 (3/20) NA Poincluoux (5/5) 100 (5/5) 0 (0/5) - et al. 20 Iwashita et al (16/20) - 80 (16/20) 15 (3/20) Hematoma(1), pancreastitis(2) Overall (187/220) 76 (70/92) 82 (314/382) 13 (48/382) a NA: Not available, #: In this study, the transgastric route and a 19-gauge needle were mainly used. $: There are overlapping cases. of procedural accidents by the puncture route were 17% for the IHBD puncture route and 8% for the EHBD puncture route. Maranki et al. 11 reported that cholangiography was successful in 84% of 49 cases of EUS-guided cholangiography and that EUS-RV was successful in 65%, concluding that EUS-guided cholangiography is a feasible alternative to percutaneous transhepatic cholangiography in patients with obstructive jaundice in whom ERC has failed. Dhir et al. 6 compared the success rates of EUS-RV and precutting in 58 patients in whom bile duct cannulation was difficult. The success rate of EUS-RV was significantly higher than that of the precut papillotomy technique (98.3% vs. 90.3%; P = 0.03)The transduodenal route was selected for each. In another article, Dhir et al. 18 compared the success rates and complication rates of IHBD route and EHBD route. There was no difference in the technical success (94.1 vs. 100%). However, the IHBD route had a higher incidence of post-procedure pain (44.1 vs. 5.5%; p=0.017), and duration of hospitalization was significantly higher for the IHBD route (2.52 vs days; p=0.015). Iwashita et al. 21 reported that puncture via D2 using a short position is the first-line transduodenal route. Their results show that access to the EHBD from the D2 was possible in

5 100 T. Tsuchiya et al. Digestive Endoscopy 2016; 28 (Suppl. 1): Table 2 Comparison of three approach routes IHBD EHBD Puncture site Stomach D1 D2 Scope position Straight Push (long) Pull (short) Scope stability Stable Stable Easy to slip Needle direction Distal Hepatic hilar Distal Guidewire manipulateon Sometimes difficult Moderate Easy Diameter of bile duct Small Large Large Distance to the papilla Long Short Very short Guidewire stability during scope exchange Good Poor Poor Risk of bile leak Low High High 50% of the patients (10/20) with a EUS-RV success rate of 100% in these attempts (10/10). In the remaining 10 patients, the biliary duct was accessed from the D1 via the EHBD in 5 patients and from the stomach via the IHBD in 4 patients with a success rate for these EUS-RV attempts of 66.7% (6/9). Shah et al. 14 reported a success rate of 74% in 50 patients undergoing EUS-RV. Among patients with EUS-RV failure, seven underwent percutaneous transhepatic biliary drainage and six underwent EUS-guided biliary drainage. The main reason for EUS-RV failure was difficult GW manipulation. Careful selection of the biliary duct puncture point and scope position for feasible guidewire manipulateon is important to assure successful EUS-RV. Discussion Regarding the history of EUS-RV, Wiersema et al. 22 performed bile duct contrast imaging under EUS guidance for the first time in 1996 and reported the possibility of the bile duct approach to endosonography-guided cholangiopancreatography. In 2001, Giovannini et al. 23 reported endoscopic ultrasoundguided bilioduodenal anastomosis, a new technique for biliary drainage in which the extrahepatic bile duct was punctured via the duodenum and a stent was inserted, the so-called EUS-guided choledochoduodenostomy. In 2003, Burmester et al. 24 punctured the intrahepatic bile duct via the jejunum in patients undergoing postoperative Roux-en-Y gastric anastomosis or via the remaining stomach in patients undergoing gastrectomy and placed a stent to provide EUS-guided intrahepatic bile duct and EHBD drainage. Giovannini et al. 25 reported transgastric intrahepatic bile duct drainage the same year. Meanwhile, in 2004, Mallery et al. 8 reported on two patients with ERCP failure who underwent bile duct drainage as EUSguided rendezvous drainage of obstructed biliary and pancreatic ducts along with four patients with pancreatic duct drainage. Puncture route selection is critical in successful EUS-RV cases. There are two puncture routes: transgastric puncture of the IHBD and transduodenal puncture of the EHBD. The scope becomes nearly straight in transgastric puncture of the IHBD, which facilitates needle insertion and puncture. However, the longer distance between the access point and the ampulla decreases the pushability and torque transmission of the guidewire needed to pass though the downstream resistance. 26 With the transduodenal puncture route, the distance to the papilla is short when a puncture via D2 is performed with the scope in a stretched state (short position); however, the scope becomes unstable and easily detaches. In puncture via D1, the scope stabilizes when in a push position; however, puncture is commonly made toward the hepatic hilar, making it difficult to advance the guidewire toward the papilla. Table 2 shows the characteristics of each puncture route. Since there are liver tissues around the IHBD, some groups prefer the IHBD approach since it has a lower risk of bile leakage than the EHBD approach. 9,14 In our institution, transgastric puncture of the IHBD (B2) is often conducted because it is easier to advance a guidewire toward the hepatic hilar in a puncture via B2 instead of B3. The guidewire becomes relatively straight and a puncture is performed from immediately below the gastroesophageal junction; therefore, at the time of duodenoscope insertion, it does not commonly interfere with a guidewire even if the greater curvature of the stomach is pushed or the scope is in a push position. EUS-RV cannot be successfully performed unless the guidewire is advanced to the puncture needle, bile duct, stenosis site, or papilla. We think hydrophilic GW is useful for this procedure. Dhir et al. 6 reported the usefulness of a hydrophilic GW for passing the papilla, although they used a short GW (260 cm). But Isayama et al. 7 said that a longer (400 cm, available commercially) GW might be provide better results. We also used a long guidewire; an assistant s skills manipulating a guidewire are also important in successful procedures. All reports state that intraductal manipulation of the guidewire seems to be the most difficult part of the procedure. Since EUS-guided intervention is not a standard procedure, we recommend that it be performed only by skilled endoscopists in a referral center.

6 Digestive Endoscopy 2016; 28 (Suppl. 1): EUS-guided rendezvous technique 101 CONCLUSION OUR LITERATURE REVIEW revealed that EUS-RV is a useful salvage method in patients in whom bile duct cannulation during ERCP is difficult. However, the procedure has yet to be standardized, including details such as puncture routes and guidewires to be used. The development of exclusive devices for EUS-RV and prospective comparative studies with other salvage methods are needed to truly evaluate the procedure s usefulness and safety. CONFLICT OF INTERESTS AUTHORS DECLARE NO conflict of interests for this article. REFERENCE 1 Sundaralingam P, Masson P, Bourke MJ. Early Precut Sphincterotomy Does Not Increase Risk During Endoscopic Retrograde Cholangiopancreatography in Patients With Difficult Biliary Access: A Meta-analysis of Randomized Controlled Trials. Clin. Gastroenterol. Hepatol. 2015; 13: Tanaka R, Itoi T, Sofuni A, et al. 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