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

Chinese University of Hong Kong77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

EUS-guided choledocho-duodenostomyPROCEDURE

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.

Endoscopic retrograde cholangiopancreatography with covered metallic stentPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Royal Prince Alfred Hospital

Sydney, Australia

The University of Leuven

Leuven, Belgium

Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Aarhus University Hospital

Aarhus, Denmark

Tokyo Medical University Hospital

Tokyo, Japan

Wakayama Medical University School of Medicine

Wakayama, Japan

Outcomes

Primary Outcomes

stent patency rate

Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.

Time frame: 1-year

Secondary Outcomes

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