Originalarbeit

385

Percutaneous transhepatic cholangiography and drainage using extravascular contrast enhanced ultrasound

Authors

A. Ignee, X. Cui, G. Schuessler, C. F. Dietrich

Affiliation

Medizinische Klinik 2, Caritas Krankenhaus, Bad Mergentheim

Schlüsselwörter

Zusammenfassung

Abstract

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Hintergrund: Die perkutane transhepatische Cholangiografie und Drainage (PTCD) ist eine übliche Prozedur zur Diagnose und Behandlung von benignen und malignen Gallengangerkrankungen. Der Ultraschall (US) wird häufig aber nicht regelhaft zur Steuerung eingesetzt. Eine konventionelle Fluoroskopie wird zur Evaluation des biliären Systems eingesetzt, führt jedoch zur signifikanten Strahlenexposition des Patienten und des interventionellen Teams. Ziel dieser Studie ist die Fähigkeit des extravaskulären Kontrastmittelultraschalls (EVKMUS) in Reduktion der Strahlenexposition bei der PTCD zu evaluieren. Patienten und Methoden: 38 Patienten erhielten eine PTCD. Portionen zu 2 – 4 mL einer SonoVue®-Verdünnung wurden wiederholt in die Gallenwege und den Dünndarm injiziert um die korrekte Position von Punktionsnadel und Drainage darzustellen sowie nach Komplikationen zu suchen. Die Resultate wurden mit der konventionellen Durchleuchtung verglichen. Ergebnisse: Die Erfolgsrate für die Cholangiografie betrug 100 % für den EVKMUS und die Durchleuchtung. 27/38 Patienten (71 %) erhielten einen Ring-Katheter, 5/38 Patienten (13 %) einen Metallstent. Eine ausschließlich externe Drainage war nach der ersten Intervention bei 6/38 Patienten (16 %) möglich, bei 50 % konnte eine Internalisierung im zweiten Versuch erzielt werden. Mittels EVKMUS konnte die korrekte Höhe der Obstruktion bei allen Patienten dargestellt werden. Die Bestimmung des richtigen Ausmaßes der Obstruktion (komplett, inkomplett) gelang bei 37/38 Patienten (97 %). In keinem Fall gelang die Darstellung des Führungsdrahts mittels Sonografie. Bei 1 von 38 Patienten (3 %) entstand ein perihepatisches Hämatom, welches konservativ behandelt werden konnte. Eine Dislokation trat bei 2/38 Patienten (5 %) während des weiteren Verlaufs auf und konnte

Background and purpose: Percutaneous transhepatic cholangiography and drainage (PTCD) is a common procedure for the diagnosis and treatment of benign and malignant biliary diseases. Ultrasound (US) is frequently used for the guidance of PTCD. Conventional fluoroscopy is applied to evaluate the biliary system, but delivers significant X-ray dosage to the patient and the interventional team. The purpose of this study is to test the ability of extravascular contrast-enhanced ultrasound (EV-CEUS) in US-guided PTCD to reduce or replace fluoroscopy. Patients and methods: 38 patients underwent PTCD. 2 − 4 mL doses of a SonoVue® dilution were repeatedly injected to demonstrate correct needle and drainage positions in the biliary system and in the intestine during the intervention and during follow-up to screen for complications. The results were compared to those of conventional radiography. Results: The success rate for cholangiography was 100 % for EV-CEUS and fluoroscopy each. 27/38 patients (71 %) received a ring catheter, 5/38 patients (13 %) received a metal stent. Only external drainage was possible in 6/38 patients (16 %) in the first session. In 50 % of them (3/38, 8 %) internalization was possible in the second attempt. With EV-CEUS the level of obstruction could be correctly diagnosed in 100 % of the patients. The degree of obstruction (complete/incomplete) could be correctly diagnosed in 37/38 patients (97 %). EV-CEUS was not able to demonstrate the guide wire. In 1/38 patient a hematoma appeared which was managed conservatively. Dislodgement was diagnosed in 2/38 (5 %) patients during follow-up by injecting EV-CEUS solution into the drain. Pleural injury with fistula could be demonstrated in 1/38 (3 %) patients. Conclusion: EV-CEUS can monitor the success of insertion of needle and catheter, demonstrate or

● Cholangiografie ● Ultraschall ● Mikroblasen ● Drainage ● Gallengang ● Komplikationen " " " " "

Key words

● cholangiography ● ultrasound ● microbubbles ● drainage ● bile duct ● complications " " " " " "

received accepted

20.9.2014 14.12.2014

Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1398796 Z Gastroenterol 2015; 53: 385–390 © Georg Thieme Verlag KG Stuttgart · New York · ISSN 0044-2771 Correspondence Dr. Andre Ignee Medizinische Klinik 2, Caritas Krankenhaus Uhlandstr. 7 97980 Bad Mergentheim Germany Tel.: ++ 49/79 31/5 80 Fax: ++ 49/79 31/58 22 90 [email protected]

Ignee A et al. Percutaneous transhepatic cholangiography … Z Gastroenterol 2015; 53: 385–390

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Perkutane transhepatische Cholangiografie und Drainage mittels extravaskulärer Anwendung von kontrastmittelverstärktem Ultraschall

Originalarbeit

durch ECVEUS diagnostiziert werden. Eine Pleurafistel wurde ebenso diagnostiziert (1/38, 3 %). Schlussfolgerung: Mittels EVKMUS kann während der PTCD die Insertion der Nadel und des Katheters kontrolliert werden. Weiterhin können Komplikationen nachgewiesen oder ausgeschlossen werden. Hiermit ist eine signifikante Reduktion der Strahlendosis denkbar. Die Durchleuchtung bleibt erforderlich zur Steuerung von Führungsdrähten wenn, eine Stenose passiert werden soll. Wird nur eine rein externe Drainage angestrebt, kann auf die Fluoroskopie verzichtet werden.

exclude complications, and therefore significantly reduce fluoroscopy time in US-guided PTCD. Fluoroscopy is needed whenever subtle wire steering is necessary as in most cases when the intestinal position of the drain is sought. If only external drainage is necessary fluoroscopy can be omitted.

Introduction

Contraindications for PTCD included lack of informed consent and severe coagulation disorders. Ascites and a puncture route through malignant tumors were considered to be relative contraindications. ERCP is considered the method of choice since it is repeatable, easy to perform in patients without dilated bile ducts and considered to have fewer adverse events. Nevertheless there is no meta-analysis, and the published cohorts are frequently not randomized. Thus PTCD could be performed in patients with a lower performance status, or in whom ERCP failed. In fact PTCD is thought to be more invasive but can be performed without general anesthesia and is faster in patients with dilated bile ducts. Another advantage is its feasibility in the case of insurmountable stenosis using external drainage. Contraindications for Sonovue were regarded in extravascular use as in IV use since in interventions the contrast agent may have contact with the blood pool during the intervention

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Percutaneous transhepatic cholangiography and drainage (PTCD) is a common procedure for the diagnosis and treatment of benign and malignant biliary diseases [1 – 3]. PTCD also permits therapeutic interventions, such as placement of a stent across a malignant stricture, dilatation of benign biliary strictures and extraction of biliary tract stones [4]. Since the blind puncture technique of peripherally located intrahepatic bile ducts has some limitations, ultrasound (US) with the advantage of real time and non-radiation is often used for the guidance of PTCD (US-PTCD) [5, 6]. However, conventional US cannot completely evaluate the biliary tract [7]. Contrast imaging such as fluoroscopy is commonly performed to determine site and degree of the biliary obstruction [8]. Fluoroscopy delivers significant X-ray dosage to the patient and the interventional team. The “as low as reasonably achievable” (ALARA) principle should be applied [9]. In recent years, case studies have reported on the use of ultrasound contrast agents (UCA) to display the biliary tract and also to control the needle insertion and catheter placement [10 – 15]. We prospectively evaluated the benefit of using extravascular contrast-enhanced ultrasound (EV-CEUS) in US-PTCD.

Patients and methods !

Patients Patients were offered PTC in the case of repeated failure of endoscopic retrograde cholangiography (ERC) or in the case of a high likelihood for ERC failure due to surgically altered anatomy: (i) Roux-en-Y with gastric bypass, (ii) Kausch-Whipple resection, (iii) pylorus-preserving Whipple resection, (iv) Roux-en-Y with hepaticojejunostomy, (v) choledochojejunostomy, or pancreaticojejunostomy [16] Patients with former Billroth I operation do not actually pose a problem for conventional ERC, patients with Billroth II operation received at least two attempts of ERC with a straight viewing endoscope and specific devices. Possible indications for PTCD are " Table 1. listed in ● 38 patients underwent PTCD due to primary or secondary bile duct obstruction, 25 males (66 %) and 13 females, age 67 ± 11 [44 − 83] years. No patients suffered from severe cardiopulmonary insufficiencies and coagulation disorders. 36 of the 38 patients who finally received PTCD had normal upper GI tract anatomy but unsuccessful conventional endoscopic retrograde cholangiography (ERC) due to failure of papilla cannulation or unsuccessful attempts of passage of the stenosis. In 2 of the 38 patients with a final PTCD procedure, ERC was not attempted due to former Roux-en-Y surgery in which we found ERC success unlikely. The indications refer" Table 1). red to the following criteria (●

Methods Four US systems were used to guide PTCD: GE Logiq E9 US system (GE Medical Systems, Milwaukee, WI, USA) (in 18/38 (47 %) patients), Siemens ACUSON Sequoia 512 (Siemens Healthcare, Erlangen, Germany) (in 5/38 (13 %) patients), Hitachi Preirus US system (in 8/38 (21 %) patients) and Hitachi Ascendus US system (Hitachi-Aloka Medical, Ltd., Japan) (in 7/38 (18 %) patients). GE Logiq and Acuson Sequoia were used for follow-up, and Acuson Sequoia was used if GE Logiq E9 was not available. Convex array probes without a puncture frame were used. Materials used included (i) 20 G Chiba needle, (ii) 60 cm 0.018 inch uncoated steel wire, (iii) 5 F straight catheter with a stiffening cannula, (iv) 90 cm 0.038 inch uncoated steel wire, (v) 8, 10, 12 F dilatators, (vi) 8.3 F straight pigtail catheters for external drainage, (vii) 10 F ring catheters with a 3.5 cm long angled section and side holes at the distal end over 7 cm for internal-external drainage, or alternatively, (viii) 12 or 14 F Munich drainage catheters with a fixation disc and side holes over the distal 25 cm, (all materials above by Peter Pflugbeil GmbH, Zorneding,

Table 1

Indication criteria for PTCD [6, 22, 23].

Evaluation of biliary anatomy in presence (or absence) of benign (e. g., stones, sclerosing cholangitis, inflammatory strictures) or malignant biliary obstruction (e. g., cholangiocarcinoma, pancreatic carcinoma, metastatic disease). Permitting therapeutic interventions, such as cholangioplasty for biliary strictures, dilation of benign biliary strictures and extraction of biliary tract stones. Management of postoperative or posttraumatic bile leakage and complications from laparoscopic cholecystectomy and liver transplantation. As a preferred procedure in patients with a history of anatomy-altering surgeries, such as the Billroth II procedure.

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Characterization of the stenosis (indications) in the 38 patients.

indications

number

ductal adenocarcinoma of the pancreas

11

29 %

6

16 %

common bile duct stone

percentage

Klatskin tumor

6

16 %

inflammatory stricture due to pancreatitis

5

13 %

pancreatic metastases

2

5%

lymph node metastases

3

8%

duodenal carcinoma

2

5%

intrahepatic cholangiocellular carcinoma

1

3%

large cell neuroendocrine carcinoma of the papilla of Vater

1

3%

intraductal papillary mucinous neoplasm

1

3%

Germany) or alternatively (ix) 80 × 10 or 60 × 10 mm uncovered self-expanding metal stents (Zilver, Cook, Ireland). 0.1 mL of SonoVue® (Bracco, Italy) in 20 mL physiological saline solution was used as UCA with boluses of 2 − 4 mL as formerly proposed [11]. PTCD was always performed using ultrasound for puncture of the bile duct with sterile covered probes and with one physician only. For fluoroscopy non-ionic iodinated contrast agent Ultravist® 240 mg/mL (Schering AG, Germany) was diluted with sterile saline at a ratio of 1:3. Prior to the intervention conventional US was performed to assess the extrahepatic and intrahepatic bile ducts including the diameter and echogenicity. In addition, liver and spleen, perihepatic lymph nodes, pancreas, and kidneys were scanned. For patients with FLL, intravascular CEUS with SonoVue® was also used to evaluate the vascularization. The enhancement pattern was compared to the CEUS liver Guidelines 2012 [17]. All patients had previously had imaging procedures including computed tomography (CT) and endoscopic ultrasound (EUS) for evaluating the cause of jaundice and the level of obstruction. The diagnosis was made on the basis of the methods mentioned " Table 2). above (●

Percutaneous transhepatic cholangiography and drainage The patient was placed in a supine position. The drainage route and the puncture site were defined with B-mode US. A dilated bile duct in segment 5 or 6 was preferred since it offers direct anterior or lateral access via an intercostal route. A bile duct section with a course of approximately 45° to the liver surface was sought anticipating an intercostal puncture route aiming caudally to cranially. All interventional procedures were performed by a single physician (AI) assisted by a physician guiding the sedation and a nurse. After skin disinfection and injection of local anesthesia the chosen bile duct was punctured using a 20 G Chiba needle. A sterile probe cover was used. After aspiration of bile 2 − 4 mL of the UCA solution was injected to confirm the intraductal position and the level of obstruction. After injecting the UCA conventional fluoroscopy was performed injecting few milliliters of X-ray contrast agent. In all cases UCA were always injected before X-ray contrast agents. We chose this timely order of the CA injection to avoid the potential influence of conventional X-ray CA on the ultrasound image. A 0.018 inch steel wire was introduced, the needle removed and a 5 F drain was positioned over the wire. Again 2 − 4 ml of UCA solution were injected followed by few milliliters of X-ray contrast agent. A 0.035 inch steel wire with a soft tip was inserted and sought a way over the stenosis into the duodenum or the anastomosed small bowel. This procedure was

monitored using fluoroscopy. If the intestine was reached the 5 F drain was pushed forward and the position was proven with intestinography using EV-CEUS and fluoroscopy. The pathway was dilated with dilatators and the anticipated drainage procedure was performed. In patients with malignant stenosis a self-expanding metal stent was chosen, in most cases as a metachronous procedure. The position of the catheter or the stent was again confirmed by the administration of EV-CEUS and fluoroscopy. Sufficient contrast enhancement could be observed for at least 5 minutes in all patients. 3 D CEUS was also performed when GE Logiq E9 was used. Once in position, the catheter was secured with retention sutures locking on the shaft of the catheter. Finally, the catheter was attached to a drainage bag. In some patients alternative wires mostly with Terumo tips were used. If a stenosis could not be passed a drain was placed into the pre-stenosis bile ducts and a second attempt was performed 2 – 4 days later when the bile ducts diameter had decreased.

Complications The day after PTCD, EV-CEUS was performed again to assess possible complications, including bleeding, hematoma, perforation, pleural or colonic injury and catheter-related complications, such as blockage or dislodgement.

Image analysis The levels of obstruction were divided into hilar (above cystic duct) and extrahepatic (below cystic duct) obstructions. The degrees of obstruction were divided into complete (UCA stops at the level of the obstruction) and incomplete obstructions (UCA was detected distally to the obstruction, in most cases in the intestine).

Results !

According to the clinical, pathological or surgical presentation as well as the results of biochemistry analysis, the causes of obstruc" Table 2. tion in the study are summarized in ●

Success rate A right hepatic approach was chosen in 33/38 (87 %) patients and a median left hepatic approach because of localized right-sided perihepatic ascites in 5/38 (13 %) patients. The success rate for cholangiography was 100 %. In 4/38 (11 %) patients a second session was necessary. The needle tip could be shown by injection of UCA in all patients. An internal-external catheter (ring catheter or Munich catheter) was placed in 27/38 patients (71 %), a metal stent was placed in 5/38 (13 %) patients. External drainage only was achieved in 6/38 (16 %) patients in whom an external catheter (8.3 F pigtail) was placed into the pre-stenotic bile ducts. In 3 of 38 patients (8 %) several days later a second attempt was successful resulting in placement of a drain over the obstruction. 2 of the patients with external drainage only received palliative biliodigestive anastomosis, 1 patient was not stable enough for surgery and died 2 weeks later with the drain left in place. Therefore, a total of 44 US guided PTCD were performed. The success rate of puncture and catheter placement was 100 % " Fig. 1, 2). 3 D CEUS was also performed in 18 patients; the (● bile duct tree could be demonstrated. Regarding the fluoroscopy finding as standard, EV-CEUS correctly diagnosed the hilar obstruction in 8 patients and extrahepatic obstruction in 30 patients, the accuracy was 100 %. There were 10

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Table 2

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Fig. 1 A 63-year-old female patient with complete biliary obstruction due to Klatskin tumour. a: Ultrasound showed the dilated bile ducts on overlay mode, b: Fluoroscopy image (also demonstrated the biliary tree).

Fig. 2 An internal-external catheter was placed on an 83-year-old female patient with prepapillary calculus and postoperative acute biliary pancreatitis. Conventional fluoroscopy gives an excellent overview. A 12 F internal-external catheter was correctly placed (b), and intestinography is shown in (c, d).

incomplete obstructions on fluoroscopy, however, EV-CEUS just found 9 of them by demonstrating UCA signals in the duodenum. The accuracy of EV-CEUS to assess the degree of obstruction was " Fig. 1). 97.4 % (37/38) (● The guide-wire could be inserted into the bile duct in all patients. Passage of the stenosis was possible in 32 patients [to allow internal-external drain (n = 27) either with Ring catheter, Munich catheter or a metal stent (n = 5)], but could not be passed in 6 patients during the same examination. In 6 patients with only an external catheter, several days after the placement, an internalexternal catheter was inserted to replace the external catheter using a 0.035 inch guide-wire. Fluoroscopy proved the position of the guide-wire in all these patients. However, conventional US could not clearly demonstrate the position of the guide-wire tip in these patients. US could not confirm whether the tip of the guide-wire had passed the obstruction into the duodenum.

Complications During the US examination on the next day, subcutaneous bleeding (hematoma) was shown in 1 patient. This could be managed conservatively. By injecting the UCA into the catheter, dislodgement was diagnosed in 2 of 38 patients (5 %), and required re-in" Fig. 3). Pleural injury resulting in pleursertion of the catheter (● al effusion and fistula of pleural and peritoneal cavity was " Fig. 3). diagnosed by EV-CEUS in one patient (●

Discussion !

The feasibility of CEUS-guided PTCD (CEUS-PTCD) was initially described in 2009 [11]. Injection of UCA could show the needle position in the biliary ducts as well as the site and degree of the biliary obstruction. Later a case report showed the usefulness of EV-CEUS in the diagnosis of biliary leakage following T-tube removal [12]. Thereafter, two studies [14, 15] were published to evaluate the usefulness of EV-CEUS in the assessment of biliary

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obstruction. This technique was described recently in a pictorial essay [18] and also in the EFSUMB non-liver CEUS Guidelines [19]. Conventional US has some limitations in confirming the correct position of the needle and/or catheter into the bile ducts [20]. The material of the catheter is not optimized for ultrasound visualization. Therefore, fluoroscopy is usually needed. In a recent study by Xu et al. [15], conventional US could just visualize 53.8 % (43/80) of the drainage catheters within the bile ducts, however, EV-CEUS identified all 80 tips (100 %). In this series, EV-CEUS could identify the needle and catheter position in all patients. When the catheter was incorrectly inserted, the bile ducts were not enhancing, the injection of the UCA can be felt with resistance or contrast leakage into the blood vessels may be found with subsequent enhancement of the liver. This resulted in 4/38 (10.5 %) patients requiring a second attempt. In two studies, EV-CEUS could correctly determine the level of obstruction in 96.6 % (56/58) [14] and 100 % (80/80) [15] patients, respectively, compared with fluoroscopy as the gold standard. In the present study, EV-CEUS correctly diagnosed the level of the obstruction in 100 % of the patients: hilar in 8 of 37 (22 %) patients and extrahepatic in 29/37 (78 %) patients. In the study by Xu et al. [15], EV-CEUS correctly diagnosed the biliary obstruction degree (complete or incomplete) in 96.3 % (77/80) of patients. In our study, the accuracy was 97.4 % (37/38), only one incomplete obstruction was misdiagnosed as complete obstruction, because contrast agent was found in the duodenum on fluoroscopy, but not by EV-CEUS. Besides, perhaps an insufficient dosage of UCA X-ray is superior to US when the latter is limited by gas filled bowel structures. An inferior accuracy of EV-CEUS is assumed in patients with surgically altered bowel anatomy when compared to patients with an unaltered situation although it is not demonstrated in our results. An explanation may be abdominal wall scarring and overlying gas filled bowel structures. Luyao et al. reported that the combination of US and EV-CEUS could determine the etiology of 92.3 % (24/26) hilar obstructions and 93.8 % (30/32) extrahepatic obstructions, while the accuracy of conventional PTC was 84.6 % (22/26) for determining the cause of hilar obstructions and 75 % (24/34) for extrahepatic obstructions [14]. Thus, US combined with EV-CEUS is superior to conventional PTC when evaluating the causes of extrahepatic obstruction. US could directly visualize the lesion when the obstruction was found on EV-CEUS while conventional PTC with fluoroscopy could not (only depicting the morphology of the obstruction). We feel that this fact does not play an important role since patients with unknown obstruction etiology should firstly undergo diagnostic imaging for avoiding invasive procedures in potentially curative neoplastic obstructions. The cause of obstruction was known in all of our patients when PTCD was performed.

EV-CEUS could demonstrate at least the second order branches of the biliary tree. In the study by Luyao et al. the first order to the third order bile ducts were visualized in all 56 patients [14]. In addition, 3 D techniques are helpful for a better understanding of the architecture of the bile duct stenosis [10, 13, 21]. The replacement of fluoroscopy by EV-CEUS was suggested in one study [15] since this procedure could also evaluate the location of the drainage catheter and the biliary obstruction, in addition, it is time-saving, available at the bed-side, and without radiation exposure. The main advantage of fluoroscopy in PTCD procedures is to pilot the guide-wire if performed with the Seldinger technique [21] which is the regular way. Studies are needed providing detailed information about the exact amount of X-ray dosage saved by using EV-CEUS. The additional costs are manageable. Since only drops are necessary there will be enough left in a vial to perform conventional investigations with the normal dose. The additional expenditure of time was moderate. It included the preparation of the contrast agent and an additional bowl for 40 mL of saline solution in which 2 – 4 drops of Sonovue were filled just before the intervention as well as the time for injection into the needle and into the drain. For patients with an external drain only, the guidewire could be easily inserted into the bile duct without the assistance of fluoroscopy. However, for the 33 patients who needed an internal-external catheter and 5 patients with metal stents to pass the obstruction, fluoroscopy was necessary. It is evident that EV-CEUS can replace most usages for fluoroscopy in PTCD except for drainage passage into the intestine if this is required for confirmation of needle position and confirmation of the site of obstruction. If a simple external drainage is required EV-CEUS simplifies the procedure by changing it into a be- side method so that patients can remain on intensive care units receiving full support of vital functions.

Limitations of our study (i) Patients were not randomized into conventional and CEUSPTCD. (ii) The number of patients is relatively small.

Conclusion !

EV-CEUS is feasible and has potential to significantly reduce fluoroscopy in PTCD procedures and replace it in external drainage only procedures.

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Fig. 3 Complications: in (a) catheter dislodgement was demonstrated by UCA around the liver, and the fistula could be demonstrated (arrow). Example (b) shows the appearance of UCA into the pleural cavity after drainage of an abscess and PTCD [24].

Originalarbeit

Acknowledgements !

The authors acknowledge Bad Mergentheimer Leberzentrum e. V. supporting Dr. XinWu Cui.

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Percutaneous transhepatic cholangiography and drainage using extravascular contrast enhanced ultrasound.

Percutaneous transhepatic cholangiography and drainage (PTCD) is a common procedure for the diagnosis and treatment of benign and malignant biliary di...
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