Ultrasound-guided Percutaneous Biliary Drainage Versus Endoscopic Ultrasound-guided Biliary Drainage (PUMa)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03546049|
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : March 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bile Duct Obstruction, Extrahepatic||Procedure: US-guided percutaneous biliary drainage Procedure: EUS-guided biliary drainage||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|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)|
|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|
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
- 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
- Clinical success [ Time Frame: 7 days after the intervention ]Decrease of bilirubin level on more than a half of the initial value
- Adverse events [ Time Frame: Up to 30 days after the intervention ]All adverse events caused by 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
- 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
- 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)
- Survival time [ Time Frame: Follow up of six months ]Time from the day of intervention to the death of the patient
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
|Contact: Daniel Schmitz, Dr.firstname.lastname@example.org|
|Contact: Jochen Rudi, Prof.Dr.email@example.com|
|Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital||Recruiting|
|Mannheim, Germany, 68165|
|Contact: Daniel Schmitz, MD 00496214245575 firstname.lastname@example.org|
|Contact: Jochen Rudi, MD PD 00496214245937 email@example.com|
|Principal Investigator: Daniel Schmitz, MD|
|Study Director:||Anja Sander, Dr.M.Sc.||Institut für Medizinische Biometrie und Informatik Abteilung Medizinische Biometrie, Heidelberg University Hospital|