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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 77
- Locations
- 6
- Primary Endpoint
- stent patency rate
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old with informed consent
- •Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- •Inoperability by staging, comorbidities or patient wishes
- •Distal tumors 2cm away from the portal hilum
- •Bilirubin > 50umol/L at diagnosis
Exclusion Criteria
- •Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria)
- •Presence of main portal vein thrombosis
- •Prior SEMS placement
- •Intraductal papillary mucinous carcinomas
- •Prior Billroth II or roux-en Y reconstruction
- •History of bleeding disorder or use of anticoagulation
- •Child's B/C cirrhosis
- •Pregnancy
- •Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
- •Presence of other malignancy
- •Life expectancy < 3months
Arms & Interventions
ECDS
EUS-guided choledocho-duodenostomy
Intervention: EUS-guided choledocho-duodenostomy (Procedure)
ERCP with CSEMS
Endoscopic retrograde cholangiopancreatography with covered metallic stent
Intervention: Endoscopic retrograde cholangiopancreatography with covered metallic stent (Procedure)
Outcomes
Primary Outcomes
stent patency rate
Time Frame: 1-year
Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
Secondary Outcomes
- Clinical success(1 year)
- Technical success(1year)
- Adverse events(30 days)
Investigators
Anthony Teoh
Honorary Associate Professor
Chinese University of Hong Kong