Clinical trial NCT03541590: Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance
Official title: Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance in Patients With Malignant Extrahepatic Bile Duct Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Obstruction, Extrahepatic
Keywords: percutaneous biliary drainage
Lead sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients which met the mentioned inclusion and exclusion criteria were enrolled in the study consecutively

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: technical success
timeFrame: 1 minute after injection of a radiocontrast agent into the expanded metal stent
Secondary outcomes:
measure: clinical success
timeFrame: 7 days
measure: adverse events
timeFrame: Up to 30 days after the intervention
measure: re-interventions
timeFrame: 6 months
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic
Study officials:
affiliation: Theresienkrankenhaus und St.Hedwigsklinik GmbH
name: Jochen Rudi, Prof.Dr.med.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.