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

Primary Purpose

Malignant Biliary Obstruction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EUS-guided choledocho-duodenostomy
Endoscopic retrograde cholangiopancreatography with covered metallic stent
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Biliary Obstruction focused on measuring Malignant biliary obstruction, EUS - guided choledocho-duodenostomy, ERCP with covered metallic stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Prince Alfred Hospital
  • The University of Leuven
  • Chinese University of Hong Kong
  • Aarhus University Hospital
  • Tokyo Medical University Hospital
  • Wakayama Medical University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ECDS

ERCP with CSEMS

Arm Description

EUS-guided choledocho-duodenostomy

Endoscopic retrograde cholangiopancreatography with covered metallic stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Technical success
Technical success is defined as the ability to access and drain the CBD by placement of a stent.
Clinical success
Clinical success is defined as >30% drop in bilirubin levels
Adverse events
Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events

Full Information

First Posted
December 20, 2016
Last Updated
August 30, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Tokyo Medical University, Kinki University
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1. Study Identification

Unique Protocol Identification Number
NCT03000855
Brief Title
EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Tokyo Medical University, Kinki University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Biliary Obstruction
Keywords
Malignant biliary obstruction, EUS - guided choledocho-duodenostomy, ERCP with covered metallic stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECDS
Arm Type
Active Comparator
Arm Description
EUS-guided choledocho-duodenostomy
Arm Title
ERCP with CSEMS
Arm Type
Active Comparator
Arm Description
Endoscopic retrograde cholangiopancreatography with covered metallic stent
Intervention Type
Procedure
Intervention Name(s)
EUS-guided choledocho-duodenostomy
Intervention Description
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
Intervention Name(s)
Endoscopic retrograde cholangiopancreatography with covered metallic stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
stent patency rate
Description
Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success is defined as the ability to access and drain the CBD by placement of a stent.
Time Frame
1year
Title
Clinical success
Description
Clinical success is defined as >30% drop in bilirubin levels
Time Frame
1 year
Title
Adverse events
Description
Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Teoh, FRCSEd(Gen
Organizational Affiliation
anthoyteoh@surgery.cuhk.edu.hk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Sydney
Country
Australia
Facility Name
The University of Leuven
City
Leuven
Country
Belgium
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Tokyo Medical University Hospital
City
Tokyo
Country
Japan
Facility Name
Wakayama Medical University School of Medicine
City
Wakayama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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