Randomized comparison of endoscopic bilateral stent-in-stent (SIS) versus stent-by-stent (SBS) placement for inoperable advanced malignant hilar biliary stricture: a multi-centre trial proposal.

Not Applicable

• Conditions: Malignant Hilar Biliary Strictures; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cancer - Biliary tree (gall bladder and bile duct); Surgery - Surgical techniques

• Registration Number: ACTRN12620000217909
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-24
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

All patients who have pathologically confirmed inoperable Malignant Hilar Biliary Strictures (MHSs) of Bismuth type III or IV with an estimated survival >3 months (Eastern Cooperative Oncology Group scale, <2) will be eligible for recruitment into the study. All causes of malignancy are included.
The criteria for inoperability were based on imaging studies such as Computed Tomography (CT) scan, Magnetic resonance cholangiopancreatography imaging (MRCP); cholangiography; positron emission tomography-CT; presence of comorbidities; and consensus of the surgeons.

Exclusion Criteria

Uncontrolled coagulopathy, American Society of Anaesthesiologist Class V, inaccessible papilla because of an accompanying duodenal obstruction or altered anatomy, and the inability to provide informed consent. Patients with MHSs caused by multiple metastatic lesions or lobes diffusely occupied by a massive tumour were also excluded because drainage could not be performed effectively and such cases have an inherently poor survival rate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare stent patency between the 2 placement techniques. Defined as the time between stent placement and potential stent exchange due to dysfunction. Assessed through clinical examination, CT or MRCP scan, and medical record review. Time between stent placement calculated by noting date and time of initial stent insertion and potential stent replacement.[Determined at 3 months and 6 months following stent placement.]