EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures

Phase 2

Completed

Interventions: Procedure: EUS-guided choledocho-duodenostomy
Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ECDS	EUS-guided choledocho-duodenostomy	EUS-guided choledocho-duodenostomy
ERCP with CSEMS	Endoscopic retrograde cholangiopancreatography with covered metallic stent	Endoscopic retrograde cholangiopancreatography with covered metallic stent

Primary Outcome Measures

Name	Time	Method
stent patency rate	1-year	Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.

Secondary Outcome Measures

Name	Time	Method
Clinical success	1 year	Clinical success is defined as \>30% drop in bilirubin levels
Technical success	1year	Technical success is defined as the ability to access and drain the CBD by placement of a stent.
Adverse events	30 days	Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events

Locations (6): Wakayama Medical University School of Medicine
🇯🇵
Wakayama, Japan
Royal Prince Alfred Hospital
🇦🇺
Sydney, Australia
Aarhus University Hospital
🇩🇰
Aarhus, Denmark
Chinese University of Hong Kong
🇨🇳
Hong Kong, Hong Kong, China
Tokyo Medical University Hospital
🇯🇵
Tokyo, Japan
The University of Leuven
🇧🇪
Leuven, Belgium