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

Malignant Biliary Obstruction Clinical Trial

— DRAMBO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000855
• Other study ID #: CRE-2016.193-T
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2016
• Est. completion date: December 2022

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Malignant Biliary Obstruction

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney
Belgium	The University of Leuven	Leuven
China	Chinese University of Hong Kong	Hong Kong	Hong Kong
Denmark	Aarhus University Hospital	Aarhus
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Wakayama Medical University School of Medicine	Wakayama

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Kinki University, Tokyo Medical University

Countries where clinical trial is conducted

Australia,  Belgium,  China,  Denmark,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stent patency rate	Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.	1-year
Secondary	Technical success	Technical success is defined as the ability to access and drain the CBD by placement of a stent.	1year
Secondary	Clinical success	Clinical success is defined as >30% drop in bilirubin levels	1 year
Secondary	Adverse events	Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events	30 days