Ultrasound-guided Percutaneous Biliary Drainage Versus Endoscopic Ultrasound-guided Biliary Drainage
NCT ID: NCT03546049
Last Updated: 2023-08-29
Study Results
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Basic Information
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UNKNOWN
NA
216 participants
INTERVENTIONAL
2018-12-01
2024-12-01
Brief Summary
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Detailed Description
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The hypothesis of this prospective multicenter study is that PTBD wasn´t performed in an appropriate way to compare it adequately with EUBD. The following improvements should be done. First, color Doppler ultrasound-guidance for cannulating the bile duct should be used in PTBD. The transgression of blood vessels with the risk of severe intrahepatic bleedings or hemobilia can be avoided, which are common adverse events in PTBDs when it is performed by fluoroscopic guidance. Second, the access to the bile duct from the left side of the liver should be favored. The access from the right liver side causes more adverse events such as biliary effusion or pneumothorax, as well as more patient discomfort and pain. Third, implantation of the self-expanding metal stent should be performed in the first session as a one-step procedure. This has the advantage that no further re-intervention is necessary after insertion of an external or an external/internal drainage, an outcome which can cause further adverse events such as bile duct leak along the catheter, biliary ascites or catheter dislocation. Fourth, stent release should be performed under endoscopic luminal guidance. In this way, the positioning and the correct expansion of the distal tip of the metal stent can be observed directly in comparison with the stent release which is only controlled by fluoroscopic guidance.
On the other hand, EUBD should be performed in its best manner (special metal stents included) with the three techniques that are usually necessary to perform a successful EUBD: EUS-guided antegrade transpapillary drainage, EUS-guided transhepatic drainage and EUS-guided choledochal drainage.
The study focuses on patients with malignant distal (infra-hilar) bile duct obstruction.
It is presumed that the technical and clinical success rate is equal (non-inferiority) but the adverse event rate, the number of re-interventions and the number of days of hospitalization may differ between the two interventions. An adequate number of cases (106 patients in each intervention, drop outs included) should be recruited to calculate relevant statistical differences.
Furthermore, patients will be followed over six months after the intervention to calculate an estimated survival analysis (with and without palliative chemotherapy).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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US-guided percutaneous biliary drainage
The initial percutaneous transhepatic puncture of the bile duct is performed by ultrasound guidance with a Chiba-needle (0.7 mm). After injection of a radiopaque contrast media into the bile duct system, the malignant extrahepatic bile duct stenosis can be visualized by fluoroscopic guidance (digital remote-controlled fluoroscopy device). Then a 0.018 inch guide wire is introduced and proceeded beyond the tumor stenosis into the duodenum. Next, the Chiba needle is exchanged by a 5 F catheter and the 0.018 inch guide wire is exchanged by a 0.035 inch guide wire. After dilatation of the hepatic access route with bougies up to 12 F, a self-expandable metal stent is introduced. The placement of the metal stent is controlled by endoscopic luminal guidance (gastroscope or duodenoscope).
US-guided percutaneous biliary drainage
Device: metal stent. The self-expandable metal stent is implanted percutaneously by a transhepatic access route.
The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed).
Length: 6-10 cm. Diameter: 8-10 mm.
EUS-guided biliary drainage
The initial transluminal puncture of the bile duct is performed by endoscopic ultrasound guidance (longitudinal echoendoscope) with an 19 G access needle. After injection of a radiopaque contrast media into the bile duct system, the malignant extrahepatic bile duct stenosis can be visualized by fluoroscopic guidance. Then, a 0.035 inch guide wire is introduced into the bile duct. After dilatation of the transluminal access route with a balloon catheter, a self-expandable metal stent is introduced as an antegrade biliary drainage, a transhepatic biliary drainage or a choledochal biliary drainage. The placement of the metal stent is controlled by fluoroscopic and endoscopic luminal guidance.
EUS-guided biliary drainage
Device: metal stent. The transluminal (transgastric, transduodenal or transenteric) implanted self-expandable metal stent is released via echoendoscope.
The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed) or mixed covered (one half covered, one half non-covered). The mixed covered stent is used for the transhepatic access.
Length: 6-10 cm. Diameter: 8-10 mm.
Interventions
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US-guided percutaneous biliary drainage
Device: metal stent. The self-expandable metal stent is implanted percutaneously by a transhepatic access route.
The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed).
Length: 6-10 cm. Diameter: 8-10 mm.
EUS-guided biliary drainage
Device: metal stent. The transluminal (transgastric, transduodenal or transenteric) implanted self-expandable metal stent is released via echoendoscope.
The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed) or mixed covered (one half covered, one half non-covered). The mixed covered stent is used for the transhepatic access.
Length: 6-10 cm. Diameter: 8-10 mm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ERCP was not successful or wasn´t possible due to anatomical reasons (for example status post-gastrectomy)
* At least twofold elevated bilirubin level (\> 2mg/dl)
* Histologically verified malignant disease
* Abdominal ultrasound was performed
* Computed tomography or magnetic resonance imaging of the abdomen was performed
* A written consent was given
Exclusion Criteria
* Extrahepatic cholangiocellular carcinoma (Klatskin tumor) Bismuth II-IV or intrahepatic cholangiocellular carcinoma
* Operable, malignant disease or disease which can be cured by chemotherapy (for example aggressive Non Hodgkin-lymphoma)
* Pregnancy or breastfeeding
* Participation in another trial concerning PTBD or EUBD
18 Years
ALL
No
Sponsors
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University Hospital Heidelberg
OTHER
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
OTHER
Responsible Party
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Daniel Schmitz, MD
Medical doctor, assistant medical director
Principal Investigators
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Anja Sander, Dr.M.Sc.
Role: STUDY_DIRECTOR
Institut für Medizinische Biometrie und Informatik Abteilung Medizinische Biometrie, Heidelberg University Hospital
Locations
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Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital
Mannheim, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Sharaiha RZ, Khan MA, Kamal F, Tyberg A, Tombazzi CR, Ali B, Tombazzi C, Kahaleh M. Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis. Gastrointest Endosc. 2017 May;85(5):904-914. doi: 10.1016/j.gie.2016.12.023. Epub 2017 Jan 4.
Bapaye A, Dubale N, Aher A. Comparison of endosonography-guided vs. percutaneous biliary stenting when papilla is inaccessible for ERCP. United European Gastroenterol J. 2013 Aug;1(4):285-93. doi: 10.1177/2050640613490928.
Artifon EL, Aparicio D, Paione JB, Lo SK, Bordini A, Rabello C, Otoch JP, Gupta K. Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage. J Clin Gastroenterol. 2012 Oct;46(9):768-74. doi: 10.1097/MCG.0b013e31825f264c.
Khashab MA, Valeshabad AK, Afghani E, Singh VK, Kumbhari V, Messallam A, Saxena P, El Zein M, Lennon AM, Canto MI, Kalloo AN. A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Dig Dis Sci. 2015 Feb;60(2):557-65. doi: 10.1007/s10620-014-3300-6. Epub 2014 Aug 1.
Sharaiha RZ, Kumta NA, Desai AP, DeFilippis EM, Gabr M, Sarkisian AM, Salgado S, Millman J, Benvenuto A, Cohen M, Tyberg A, Gaidhane M, Kahaleh M. Endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage: predictors of successful outcome in patients who fail endoscopic retrograde cholangiopancreatography. Surg Endosc. 2016 Dec;30(12):5500-5505. doi: 10.1007/s00464-016-4913-y. Epub 2016 Apr 29.
Lee TH, Choi JH, Park do H, Song TJ, Kim DU, Paik WH, Hwangbo Y, Lee SS, Seo DW, Lee SK, Kim MH. Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. Clin Gastroenterol Hepatol. 2016 Jul;14(7):1011-1019.e3. doi: 10.1016/j.cgh.2015.12.032. Epub 2015 Dec 31.
Sportes A, Camus M, Greget M, Leblanc S, Coriat R, Hochberger J, Chaussade S, Grabar S, Prat F. Endoscopic ultrasound-guided hepaticogastrostomy versus percutaneous transhepatic drainage for malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatography: a retrospective expertise-based study from two centers. Therap Adv Gastroenterol. 2017 Jun;10(6):483-493. doi: 10.1177/1756283X17702096. Epub 2017 Apr 10.
Schmitz D, Grosse A, Hallscheidt P, Roseneck A, Niemeyer J, Rudi J. Color Doppler ultrasound-guided PTBD with and without metal stent implantation by endoscopic control: prospective success and early adverse event rates. Z Gastroenterol. 2015 Nov;53(11):1255-60. doi: 10.1055/s-0041-104225. Epub 2015 Nov 12.
Liu YS, Lin CY, Chuang MT, Tsai YS, Wang CK, Ou MC. Success and complications of percutaneous transhepatic biliary drainage are influenced by liver entry segment and level of catheter placement. Abdom Radiol (NY). 2018 Mar;43(3):713-722. doi: 10.1007/s00261-017-1258-5.
Schmitz D, Valiente CT, Dollhopf M, Perez-Miranda M, Kullmer A, Gornals J, Vila J, Weigt J, Voigtlander T, Redondo-Cerezo E, von Hahn T, Albert J, Vom Dahl S, Beyna T, Hartmann D, Franck F, Garcia-Alonso FJ, Schmidt A, Garcia-Sumalla A, Arrubla A, Joerdens M, Kleemann T, Tomo JRA, Grassmann F, Rudi J. Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial). PLoS One. 2022 Oct 27;17(10):e0275029. doi: 10.1371/journal.pone.0275029. eCollection 2022.
Other Identifiers
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2018-PUMa-3-12-001
Identifier Type: -
Identifier Source: org_study_id
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