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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03000855




Registration number
NCT03000855
Ethics application status
Date submitted
20/12/2016
Date registered
22/12/2016
Date last updated
31/08/2023

Titles & IDs
Public title
EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures
Scientific 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
Secondary ID [1] 0 0
CRE-2016.193-T
Universal Trial Number (UTN)
Trial acronym
DRAMBO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Biliary Obstruction 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - EUS-guided choledocho-duodenostomy
Treatment: Surgery - Endoscopic retrograde cholangiopancreatography with covered metallic stent

Active comparator: ECDS - EUS-guided choledocho-duodenostomy

Active comparator: ERCP with CSEMS - Endoscopic retrograde cholangiopancreatography with covered metallic stent


Treatment: Surgery: 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.

Treatment: Surgery: 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 code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
stent patency rate
Timepoint [1] 0 0
1-year
Secondary outcome [1] 0 0
Technical success
Timepoint [1] 0 0
1year
Secondary outcome [2] 0 0
Clinical success
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
30 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2022
Sample size
Target
77
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
China
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus
Country [4] 0 0
Japan
State/province [4] 0 0
Tokyo
Country [5] 0 0
Japan
State/province [5] 0 0
Wakayama

Funding & Sponsors
Primary sponsor type
Other
Name
Chinese University of Hong Kong
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Tokyo Medical University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Kinki University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03000855
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Teoh, FRCSEd(Gen
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03000855