Ultrasound-guided Percutaneous Biliary Drainage Versus Endoscopic Ultrasound-guided Biliary Drainage

NCT03546049 | Unknown DMC

• 1 other identifier: 2018-PUMa-3-12-001
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective multi-site study of ultrasound-guided percutaneous biliary drainage and endoscopic ultrasound-guided biliary drainage with implantation of a self-expanding metal stent in patients with malignant, distal bile duct obstruction (PUMa-study)

Conditions

Bile Duct Obstruction, Extrahepatic

Keywords

ultrasound-guided percutaneous transhepatic biliary drainage; endoscopic ultrasound-guided antegrade biliary drainage; endoscopic ultrasound-guided transhepatic biliary drainage; endoscopic ultrasound-guided choledochal biliary drainage; self-expandable metal stent; malignant bile duct obstruction

Outcome Measures

Primary Outcomes (1)

• Technical success

  Successful implantation of a self-expanding metal stent to drain the obstructed bile duct, measured by the successful drainage of the radiocontrast agent by the metal stent

  1 minute after injection of a radiocontrast agent into the expanded metal stent

Secondary Outcomes (6)

• Clinical success

  7 days after the intervention

• Adverse events

  Up to 30 days after the intervention

• Re-interventions

  6 months after successful implantation of the metal stent

• Duration of the procedure

  The day of the performed procedure (24 h), usually from 10 minutes up to 180 minutes

• Length of hospital stay

  The day of the first PTBD or EUBD is counted as day 1 of hospital stay. The day of the discharge from the hospital is counted as the last day of hospital stay. An average 7 to 14 days is estimated.y.

Study Arms (2)

US-guided percutaneous biliary drainage

ACTIVE COMPARATOR

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).

Procedure: US-guided percutaneous biliary drainage

EUS-guided biliary drainage

EXPERIMENTAL

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.

Procedure: EUS-guided biliary drainage

Interventions

US-guided percutaneous biliary drainage PROCEDURE

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.

Also known as: WallFlex™ Biliary RX Stents Boston Scientific

US-guided percutaneous biliary drainage

EUS-guided biliary drainage PROCEDURE

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.

Also known as: WallFlex™ Biliary RX Stents Boston Scientific

EUS-guided biliary drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inoperable, malignant disease with extrahepatic bile duct obstruction (infra- hilar)
• 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

You may not qualify if:

• Relevant blood coagulation disorder (Quick \< 50%, Partial thromboplastin time \> 50 sec., thrombocytes \< 50/nl)
• 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

Sponsors & Collaborators

• Theresienkrankenhaus und St. Hedwig-Klinik GmbH: lead
• University Hospital Heidelberg: collaborator

Study Sites (1)

Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital

Mannheim, 68165, Germany

RECRUITING

Related Publications (10)

• 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.

  PMID: 28063840 BACKGROUND

• 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.

  PMID: 24917973 BACKGROUND

• 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.

  PMID: 22810111 BACKGROUND

• 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.

  PMID: 25081224 BACKGROUND

• 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.

  PMID: 27129552 BACKGROUND

• 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.

  PMID: 26748220 BACKGROUND

• 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.

  PMID: 28567118 BACKGROUND

• 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.

  PMID: 26562399 BACKGROUND

• 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.

  PMID: 28741168 BACKGROUND

• 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.

  PMID: 36302047 DERIVED

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Anja Sander, Dr.M.Sc.

  Institut für Medizinische Biometrie und Informatik Abteilung Medizinische Biometrie, Heidelberg University Hospital

  STUDY DIRECTOR

Central Study Contacts

Daniel Schmitz, Dr.med.

CONTACT

00496214245575; d.schmitz@theresienkrankenhaus.de

Jochen Rudi, Prof.Dr.med.

CONTACT

00496214244631; j.rudi@theresienkrankenhaus.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, assistant medical director

Model Details: prospective, non-randomized multicenter study (each center performs the intervention which can do best)

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: June 6, 2018
• Study Start: December 1, 2018
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)