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

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ClinicalTrials.gov Identifier: NCT03000855
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Tokyo Medical University
Kinki University
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Malignant Biliary Obstruction Procedure: EUS-guided choledocho-duodenostomy Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.




Primary Outcome Measures :
  1. stent patency rate [ Time Frame: 1-year ]
    Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.


Secondary Outcome Measures :
  1. Technical success [ Time Frame: 1year ]
    Technical success is defined as the ability to access and drain the CBD by placement of a stent.

  2. Clinical success [ Time Frame: 1 year ]
    Clinical success is defined as >30% drop in bilirubin levels

  3. Adverse events [ Time Frame: 30 days ]
    Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000855


Contacts
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Contact: Anthony Teoh, FRCSEd(Gen) 26322956 anthoyteoh@surgery.cuhk.edu.hk

Locations
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Australia
Royal Prince Alfred Hospital Not yet recruiting
Sydney, Australia
Contact: Arthur Kaffes         
Belgium
The University of Leuven Not yet recruiting
Leuven, Belgium
Contact: Schwalk can der Merwe         
China, Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong, China
Contact: Anthony Y Teoh, FRCSEd(Gen)    26322956    anthonyteoh@surgery.cuhk.edu.hk   
Principal Investigator: Anthony Y Teoh, FRCSEd(Gen)         
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark
Contact: Rastilav Kunda         
Japan
Tokyo Medical University Hospital Not yet recruiting
Tokyo, Japan
Contact: Takao Itoi, MD         
Principal Investigator: Takao Itoi, MD         
Wakayama Medical University School of Medicine Not yet recruiting
Wakayama, Japan
Contact: KITANO MD Masayuki         
Sub-Investigator: KITANO MD Masayuki         
Sponsors and Collaborators
Chinese University of Hong Kong
Tokyo Medical University
Kinki University
Investigators
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Principal Investigator: Anthony Teoh, FRCSEd(Gen anthoyteoh@surgery.cuhk.edu.hk

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Responsible Party: Anthony Teoh, Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03000855     History of Changes
Other Study ID Numbers: CRE-2016.193-T
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Keywords provided by Anthony Teoh, Chinese University of Hong Kong:
Malignant biliary obstruction
EUS - guided choledocho-duodenostomy
ERCP with covered metallic stents