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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Malignant Biliary Obstruction

Intervention / Treatment
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* Procedure: EUS-guided choledocho-duodenostomy
* Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECDS<br>EUS-guided choledocho-duodenostomy | Procedure: EUS-guided choledocho-duodenostomy<br>* 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.<br>|
| Active Comparator: ERCP with CSEMS<br>Endoscopic retrograde cholangiopancreatography with covered metallic stent | Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent patency rate | Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction. | 1-year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant biliary obstruction, EUS - guided choledocho-duodenostomy, ERCP with covered metallic stents