Clinical trial NCT03000855: EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Malignant Biliary Obstruction
Keywords: Malignant biliary obstruction
EUS - guided choledocho-duodenostomy
ERCP with covered metallic stents
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tokyo Medical University
name: Kinki University
First posted: 2016-12-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: stent patency rate
timeFrame: 1-year
Secondary outcomes:
measure: Technical success
timeFrame: 1year
measure: Clinical success
timeFrame: 1 year
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Leuven
country: Belgium
facility: The University of Leuven
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
state: Hong Kong
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University School of Medicine
Study officials:
affiliation: anthoyteoh@surgery.cuhk.edu.hk
name: Anthony Teoh, FRCSEd(Gen
role: PRINCIPAL_INVESTIGATOR
References: