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

August 27, 2023 updated by: Daniel Schmitz, MD, Theresienkrankenhaus und St. Hedwig-Klinik GmbH

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Mannheim, Germany, 68165
        • Recruiting
        • Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Schmitz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • WallFlex™ Biliary RX Stents Boston Scientific

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute after injection of a radiocontrast agent into the expanded metal stent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: 7 days after the intervention
Decrease of bilirubin level on more than a half of the initial value
7 days after the intervention
Adverse events
Time Frame: Up to 30 days after the intervention
All adverse events caused by the intervention
Up to 30 days after the intervention
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
6 months after successful implantation of the metal stent
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
The day of the performed procedure (24 h), usually from 10 minutes up to 180 minutes
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)
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.
Survival time
Time Frame: Follow up of six months
Time from the day of intervention to the death of the patient
Follow up of six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Collaborators

University Hospital Heidelberg

Investigators

  • Study Director: Anja Sander, Dr.M.Sc., Institut für Medizinische Biometrie und Informatik Abteilung Medizinische Biometrie, Heidelberg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-PUMa-3-12-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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