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Completed

NCT Number: NCT03541590

Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance

In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more re-interventions than endoscopic ultrasound guided biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The conclusion was, that EUBD should be prefered in this clinical setting in future.

An improved technique of PTBD may provide better results for coming comparative studies.

The investigators of this retrospective study therefore analyzed all PTBDs that were performed in a period of nine years in a tertiary referral hospital. In this cohort, the analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal guidance.

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Key information

Conditions

Bile Duct Obstruction, Extrahepatic Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Extrahepatic Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic

Mannheim, 68165, Germany

About this study

When Endoscopic Retrograde Cholangiopancreaticography (ERCP) is not successful or is not possible to be performed due to anatomical reasons (altered anatomy after abdominal surgery) in patients with malignant extrahepatic bile duct obstruction, an alternative method is necessary for biliary drainage. In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more re-interventions than endoscopic ultrasound guided biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The conclusion was, that EUBD should be prefered in this clinical setting in future.

An improved technique of PTBD may provide better results for coming comparative studies.

The investigators of this retrospective study therefore analyzed all PTBDs that were performed in a period of nine years in a tertiary referral hospital. In this cohort, the analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal guidance considering technical and clinical success, access route, procedure time, fluoroscopic time, radiation exposure, adverse events and survival probability in an observation time of six months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years
  • not curatively operable, malignant disease with proximal or distal bile duct obstruction
  • elevated serum bilirubin level and/or elevated alkaline phosphatase to at least a twofold degree
  • histologically verified diagnosis
  • at least one cross-sectional imaging method like computed tomography or magnetic resonance imaging of the abdomen has to be performed

Exclusion criteria

  • uncorrectable coagulopathy (prothrombin time < 50%, platelet count < 50.000/nl, partial thromboplastin time (PTT) > 50 sec.
  • advanced tumor disease with limited life expectancy (< 1 month)
  • diffuse liver metastasis
  • pregnant or breast feeding women
  • potentially curatively, operable, malignant bile duct obstruction
  • diseases which can be cured by chemotherapy (for example aggressive non Hodgkin-lymphoma).

Treatment and study plan

Percutaneous Transhepatic Biliary Drainage

Procedure

When ERCPs failed or was not possible to be performed due to an altered anatomy in patients with malignant extrahepatic bile duct obstruction, PTBD was performed next in all patients. Percutaneous bile duct puncture was guided by Color Doppler ultrasound. The further procedure was guided by fluoroscopy. A self-expandable metal stent (SEMS) was inserted into the obstructed bile duct by endoscopic luminal guidance in the first session. After successful SEMS implantation, the percutaneous external catheter was removed at the end of the procedure.

Primary outcomes

  1. technical success

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

    metal stent was implanted successfully bridging the tumor stenosis

Secondary outcomes

  1. clinical success

    Time frame: 7 days

    decrease of Serum Bilirubin level >50%

  2. adverse events

    Time frame: Up to 30 days after the intervention

    the report of any adverse events after the procedure, grading of adverse events according to the ASGE lexicon's severity grading system

  3. re-interventions

    Time frame: 6 months

    Number of re-interventions (ERCP or PTCD) that are necessary after successful PTBD (for example due to stent migration or stent occlusion)

  4. overall survival

    Time frame: 2 years

    death in the follow up afterperformed PTBD

Sponsors and collaborators

Lead sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Other

Registry information

Official study title

Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance in Patients With Malignant Extrahepatic Bile Duct Obstruction

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
May 30, 2018
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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