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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Procedure: EUS-guided choledocho-duodenostomy; Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent

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.

• Study Type: Interventional
• Enrollment (Estimated): 77
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Royal Prince Alfred Hospital
• Belgium
  • Leuven, Belgium
    • The University of Leuven
• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Chinese University of Hong Kong
• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
• Japan
  • Tokyo, Japan
    • Tokyo Medical University Hospital
  • Wakayama, Japan
    • Wakayama Medical University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ECDS; EUS-guided choledocho-duodenostomy	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.
Active Comparator: ERCP with CSEMS; Endoscopic retrograde cholangiopancreatography with covered metallic stent	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Tokyo Medical University; Kinki University
• Investigators: Principal Investigator: Anthony Teoh, FRCSEd(Gen, anthoyteoh@surgery.cuhk.edu.hk

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimated): December 22, 2016

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Malignant biliary obstruction; EUS - guided choledocho-duodenostomy; ERCP with covered metallic stents
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: CRE-2016.193-T