Primary Versus Secondary Metal Stent Implantation in PTBD

Bile Duct Obstruction Clinical Trial

Official title:

Primary Versus Secondary Metal Stent Implantation in PTBD in Patients With Extrahepatic Malignant Bile Duct Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992585
• Other study ID #: PTBD retro 002
• Status: Completed
• Phase: N/A
• Start date: March 1, 2011
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2021
• Source: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in terms of adverse events.

Description:

Percutaneous transhepatic biliary interventions (PBI) are used in biliary tract diseases when endoscopic access was not successful or not possible due to anatomical changes after abdominal surgery. Self-expandible metal stents (SEMS) can be applied percutaneously in patients with malignant extrahepatic bile duct obstruction. In this setting, PTBD is usually performed as a two step-procedure with primary drainage of the accumulated bile fluid by an external or an external/internal plastic stent and a secondary metal stent implantation at an interval of a few days. PTBD with primary metal stent implantation might shorten the hospital stay and is therefore equal to the increasingly used method of endoscopic ultrasound-guided biliary drainage (EUS-BD). EUS-BD offers a one step-procedure with primary metal stent implantation which is probably associated with lesser adverse events (AE) than PTBD with secondary metal stent implantation. However, it is not clear whether PTBD with primary metal stent implantation shows fewer adverse events than PTBD with secondary stent implantation. The aim of this study is to retrospectively analyze the prospectively collected data of PTBDs with primary or secondary metal stent implantation in patients with proximal and distal malignant bile duct obstruction. The focus of this single center study will be to compare the two approaches in terms of adverse events. Adverse events in PTBD might range from very mild to fatal. Therefore, the severity of the adverse events has been considered in the calculation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• PTBD with metal stent implantation into the extrahepatic bile duct

• malignant and non-resectable extrahepatic bile duct obstruction

Exclusion Criteria:

• benign extrahepatic bile duct obstruction

Related Conditions & MeSH terms

• Bile Duct Obstruction
• Cholestasis
• Cholestasis, Extrahepatic
• Extrahepatic Cholestasis

Intervention

Device:
• Percutaneous transhepatic implantation of self-expandable metal stent
A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease

Locations

Country	Name	City	State
Germany	Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Theresienkrankenhaus und St. Hedwig-Klinik GmbH	Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. — View 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. Review. — View Citation

Venkatanarasimha N, Damodharan K, Gogna A, Leong S, Too CW, Patel A, Tay KH, Tan BS, Lo R, Irani F. Diagnosis and Management of Complications from Percutaneous Biliary Tract Interventions. Radiographics. 2017 Mar-Apr;37(2):665-680. doi: 10.1148/rg.2017160159. Review. Erratum in: Radiographics. 2017 May-Jun;37(3):1004. Damodharan, Karthik [corrected to Damodharan, Karthikeyan]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	All adverse events which have been documented in the medical record were analyzed and classified as mild, moderate, severe or fatal/death according to the AE severity grading system of the American Society of Gastrointestinal Endoscopy (ASGE)	From the intervention until 30 days after