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Ultrasound-guided Percutaneous Biliary Drainage Versus Endoscopic Ultrasound-guided Biliary Drainage (PUMa)

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ClinicalTrials.gov Identifier: NCT03546049
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : March 19, 2020
Sponsor:
Collaborator:
University Hospital Heidelberg
Information provided by (Responsible Party):
Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH

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)

Condition or disease Intervention/treatment Phase
Bile Duct Obstruction, Extrahepatic Procedure: US-guided percutaneous biliary drainage Procedure: EUS-guided biliary drainage Not Applicable

Detailed Description:

In a recent systematic review and meta-analysis about the efficacy and safety of endoscopic ultrasound-guided biliary drainage (EUBD) in comparison with percutaneous transhepatic biliary drainage (PTBD), there was no difference in technical success between the two procedures, but PTBD was associated with a lower level of clinical success, a higher level of post-procedural adverse events and a higher rate of re-interventions. The authors concluded that EUBD should be favored for biliary drainage when endoscopic retrograde cholangiopancreaticography (ERCP) failed or wasn´t possible to perform due to anatomical reasons.

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, non-randomized multicenter study (each center performs the intervention which can do best)
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound

Arm Intervention/treatment
Active Comparator: 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).
Procedure: 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.

Other Name: WallFlex™ Biliary RX Stents Boston Scientific

Experimental: 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.
Procedure: 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 Name: WallFlex™ Biliary RX Stents Boston Scientific




Primary Outcome Measures :
  1. Technical success [ Time Frame: 1 minute after injection of a radiocontrast agent into the expanded metal stent ]
    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


Secondary Outcome Measures :
  1. Clinical success [ Time Frame: 7 days after the intervention ]
    Decrease of bilirubin level on more than a half of the initial value

  2. Adverse events [ Time Frame: Up to 30 days after the intervention ]
    All adverse events caused by the intervention

  3. Re-interventions [ Time Frame: 6 months after successful implantation of the metal stent ]
    Number of re-interventions (PTBD or EUBD) that are necessary in the follow up (for example due to due stent occlusion or stent migration) after successful stent implantation

  4. Duration of the procedure [ Time Frame: The day of the performed procedure (24 h), usually from 10 minutes up to 180 minutes ]
    Duration of biliary drainage procedure (US-guided percutaneous biliary drainage or EUS-guided biliary drainage) in minutes

  5. Length of hospital stay [ Time Frame: 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. ]
    Length of hospital stay from the day of the first intervention (PTBD or EUBD) to the the day of discharge (days)

  6. Survival time [ Time Frame: Follow up of six months ]
    Time from the day of intervention to the death of the patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546049


Contacts
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Contact: Daniel Schmitz, Dr.med. 00496214245575 d.schmitz@theresienkrankenhaus.de
Contact: Jochen Rudi, Prof.Dr.med. 00496214244631 j.rudi@theresienkrankenhaus.de

Locations
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Germany
Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital Recruiting
Mannheim, Germany, 68165
Contact: Daniel Schmitz, MD    00496214245575    d.schmitz@theresienkrankenhaus.de   
Contact: Jochen Rudi, MD PD    00496214245937    j.rudi@theresienkrankenhaus.de   
Principal Investigator: Daniel Schmitz, MD         
Sponsors and Collaborators
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
University Hospital Heidelberg
Investigators
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Study Director: Anja Sander, Dr.M.Sc. Institut für Medizinische Biometrie und Informatik Abteilung Medizinische Biometrie, Heidelberg University Hospital
Publications:

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Responsible Party: Daniel Schmitz, Medical doctor, assistant medical director, Theresienkrankenhaus und St. Hedwig-Klinik GmbH
ClinicalTrials.gov Identifier: NCT03546049    
Other Study ID Numbers: 2018-PUMa-3-12-001
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH:
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
Additional relevant MeSH terms:
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Cholestasis
Cholestasis, Extrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases