EUS – Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic

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

Chinese University of Hong Kong. Opens December.

Purpose
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 Intervention Phase
Malignant Biliary Obstruction
Procedure: EUS-guided choledocho-duodenostomy
Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Chinese University of Hong Kong:

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

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

Clinical success [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Clinical success is defined as >30% drop in bilirubin levels

Adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events

Estimated Enrollment: 77
Study Start Date: December 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03000855

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

Locations
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
Principal Investigator: Anthony Teoh, FRCSEd(Gen anthoyteoh@surgery.cuhk.edu.hk
More Information

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
Study First Received: December 20, 2016
Last Updated: December 21, 2016
Health Authority: Joint CUHK-NTEC Clinical Research Ethics Committee: Hong Kong

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

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 23, 2016