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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Malignant Biliary Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECDS

EUS-guided choledocho-duodenostomy

Group Type ACTIVE_COMPARATOR

EUS-guided choledocho-duodenostomy

Intervention Type PROCEDURE

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.

ERCP with CSEMS

Endoscopic retrograde cholangiopancreatography with covered metallic stent

Group Type ACTIVE_COMPARATOR

Endoscopic retrograde cholangiopancreatography with covered metallic stent

Intervention Type PROCEDURE

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.

Interventions

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EUS-guided choledocho-duodenostomy

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.

Intervention Type PROCEDURE

Endoscopic retrograde cholangiopancreatography with covered metallic stent

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.

Intervention Type PROCEDURE

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No