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Clinical Trials/CTRI/2024/12/077821
CTRI/2024/12/077821Not yet recruitingPhase 2/3

Lumen apposing metal stents versus Covered tubular self-expanding metal stents for EUS-guided choledochoduodenostomy In Distal malignant biliary obstruction: A randomized controlled trial

Jayanta Samanta3 sites in 1 country82 target enrollmentStarted: December 16, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
82
Locations
3
Primary Endpoint
Rates of re-intervention for recurrent biliary obstruction

Study Overview

Brief Summary

The gold standard for the management of malignant distal biliary obstruction (MDBO) has been endoscopic retrograde cholangiopancreatography (ERCP). Despite the advancements in endoscopic accessories and techniques, failure to cannulate may be present in 4-16% cases. In such cases, patients are salvaged with percutaneous transhepatic biliary drainage (PTBD) or surgery. Both salvage modalities have their own shortcomings. An alternative to these which has gained momentum in MBO management has been endoscopic ultrasound guided biliary drainage (EUS-BD). For MDBO, EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided hepaticogastrostomy can be done. For EUS-CDS, it is more technically easier and can be done by either tubular metal stents (SEMS) or cautery enhanced lumen apposing metal stents (EC-LAMS). Both these stents has their own set of pros and cons. But which metal stent to prefer (SEMS versus EC-LAMS) for EUS-CDS is still debatable. We hypothesized that, while EC-LAMS and SEMS would be equally effective and safe, the rates of stent dysfunction/block requiring re-intervention would be different between the two arms considering the inherent difference in the design of the two stents. Thus, this study has been planned to compare EC-LAMS versus covered tubular SEMS in EUS-CDS in terms of clinical efficacy, safety, and re-intervention rates.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • malignant distal biliary obstruction naive/prior ERCP failure or unsuccessful ERCP informed consent.

Exclusion Criteria

  • hilar or proximal biliary obstruction altered GI anatomy Unfit for endoscopic procedure uncorrectable coagulopathy or thrombocytopenia pregnancy.

Outcomes

Primary Outcomes

Rates of re-intervention for recurrent biliary obstruction

Time Frame: 6 months

Secondary Outcomes

  • 1. Technical success(2. Clinical success)

Investigators

Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Jayanta Samanta

Postgraduate Institute of Medical Education and Research, Chandigarh

Study Sites (3)

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