EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures (DRCBD)
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|ClinicalTrials.gov Identifier: NCT03000855|
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : January 30, 2019
EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain.
The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Biliary Obstruction||Procedure: EUS-guided choledocho-duodenostomy Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent||Phase 2 Phase 3|
Malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life and decrease survival. Malignant biliary obstruction is traditionally palliated with ERCP with metallic stent insertion. However, these stents are prone to obstruction due to tumour ingrowth. In addition, ERCP may not always be possible due to tumour obstruction and percutaneous biliary drainage may be required.
Recently, ECDS has been described as an alternative to percutaneous biliary drainage in patients with failed ERCP. The procedure is also associated with potential advantages as compared to conventional ERCP. In particular, the risk of tumour ingrowth into the stent placed after ECDS is low and stent patency rates may be better than ERCP. Thus, the aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures. A Multi-centred Randomised Controlled Trial|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: ECDS
Procedure: EUS-guided choledocho-duodenostomy
The CBD would be identified by a linear echoendoscope and a suitable puncture site in the bulb of the duodenum would be located. The common bile duct would be punctured with a 19-gauge needle and the position would be confirmed by aspiration of bile and contrast injection. A 0.025" or 0.035" guide wire would be passed through the needle in to the CBD. A fully covered metal stent would then be inserted after track dilation.
Active Comparator: ERCP with CSEMS
Endoscopic retrograde cholangiopancreatography with covered metallic stent
Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent
After cannulation of the CBD, a cholangiography would be performed to assess the diameter of the CBD, the length and position of the biliary stricture. The endoscopist would decide on the appropriate size of SEMS to be placed. The stents should be visible from the duodenal lumen after deployment.
- stent patency rate [ Time Frame: 1-year ]Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
- Technical success [ Time Frame: 1year ]Technical success is defined as the ability to access and drain the CBD by placement of a stent.
- Clinical success [ Time Frame: 1 year ]Clinical success is defined as >30% drop in bilirubin levels
- Adverse events [ Time Frame: 30 days ]Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events
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): NCT03000855
|Contact: Anthony Teoh, FRCSEd(Gen)||email@example.com|
|Royal Prince Alfred Hospital||Not yet recruiting|
|Contact: Arthur Kaffes|
|The University of Leuven||Not yet recruiting|
|Contact: Schwalk can der Merwe|
|China, Hong Kong|
|Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong, China|
|Contact: Anthony Y Teoh, FRCSEd(Gen) 26322956 firstname.lastname@example.org|
|Principal Investigator: Anthony Y Teoh, FRCSEd(Gen)|
|Aarhus University Hospital||Not yet recruiting|
|Contact: Rastilav Kunda|
|Tokyo Medical University Hospital||Not yet recruiting|
|Contact: Takao Itoi, MD|
|Principal Investigator: Takao Itoi, MD|
|Wakayama Medical University School of Medicine||Not yet recruiting|
|Contact: KITANO MD Masayuki|
|Sub-Investigator: KITANO MD Masayuki|
|Principal Investigator:||Anthony Teoh, FRCSEd(Genemail@example.com|