A Phase 2/3 interventional study of EUS-guided choledocho-duodenostomy and Endoscopic retrograde cholangiopancreatography with covered metallic stent in Malignant Biliary Obstruction, sponsored by Chinese University of Hong Kong. Completed at 6 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Chinese University of Hong Kong · Phase 2/3, Interventional, and Treatment
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.
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.
1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.
This study's planned enrollment of 77 is close to the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.
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Exclusion Criteria:
EUS-guided choledocho-duodenostomy
Procedure: EUS-guided choledocho-duodenostomy
Endoscopic retrograde cholangiopancreatography with covered metallic stent
Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent
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.
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
Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
Time frame: 1-year
Technical success
Technical success is defined as the ability to access and drain the CBD by placement of a stent.
Time frame: 1year
Clinical success
Clinical success is defined as \>30% drop in bilirubin levels
Time frame: 1 year
Adverse events
Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events
Time frame: 30 days
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong