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

NCT03000855 | Completed Phase 2

• 1 other identifier: CRE-2016.193-T
• Study Type: interventional
• Target: 77
• Locations: 5 countries
• Sites: 6

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.

Conditions

Malignant Biliary Obstruction

Keywords

Malignant biliary obstruction; EUS - guided choledocho-duodenostomy; ERCP with covered metallic stents

Outcome Measures

Primary Outcomes (1)

• stent patency rate

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

  1-year

Secondary Outcomes (3)

• Technical success

  1year

• Clinical success

  1 year

• Adverse events

  30 days

Study Arms (2)

ECDS

ACTIVE COMPARATOR

EUS-guided choledocho-duodenostomy

Procedure: EUS-guided choledocho-duodenostomy

ERCP with CSEMS

ACTIVE COMPARATOR

Endoscopic retrograde cholangiopancreatography with covered metallic stent

Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent

Interventions

EUS-guided choledocho-duodenostomy PROCEDURE

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.

ECDS

Endoscopic retrograde cholangiopancreatography with covered metallic stent PROCEDURE

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.

ERCP with CSEMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Tokyo Medical University: collaborator
• Kinki University: collaborator

Study Sites (6)

Royal Prince Alfred Hospital

Sydney, Australia

Location

The University of Leuven

Leuven, Belgium

Location

Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Tokyo Medical University Hospital

Tokyo, Japan

Location

Wakayama Medical University School of Medicine

Wakayama, Japan

Location

Related Publications (1)

• Teoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, Van der Merwe S, Jacques J, Legros R, Thawee RE, Saxena P, Aerts M, Archibugi L, Chan SM, Fumex F, Kaffes AJ, Ma MTW, Messaoudi N, Rizzatti G, Ng KKC, Ng EKW, Chiu PWY. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-482.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28.

  PMID: 37121331 DERIVED

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Anthony Teoh, FRCSEd(Gen

  anthoyteoh@surgery.cuhk.edu.hk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

AU (1); BE (1); CN (1); JP (2); DK (1)