Prospective study to assess the success rate and safety of placing novel lumen apposing stents (LAMS) in the bile duct to relieve jaundice

Proof of Concept Study: Safety and Feasibility Study of Lumen-Apposing Stents (LAMS) in EUS-Guided Biliary Drainage

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13196704

Enrollment

Registered

2018-05-16

Start date

2018-07-01

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant common bile duct obstruction Cancer Malignant common bile duct obstruction

Interventions

This is a prospective feasibility study to assess the safety and efficacy of EUS- guided biliary drainage. All adult participants who have inoperable distal malignant CBD stricture and failed ERCP hav

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18-90 years 2. Distal malignant CBD stricture and failed ERCP drainage secondary to either altered ampullary anatomy, difficult cannulation, duodenal infiltration or obstruction at the level of D1/D2 junction 3. Common bile duct (CBD) should at least be dilated to 14mm in diameter (it would not be technically feasible to deploy the stent with diameters less than 15mm)

Exclusion criteria

Exclusion criteria: 1. Participants suitable for curative pancreatic or bile duct resection (participants are reviewed in HPB MDM for this and then recruited if they are considered inoperable) 2. All participants who have proximal malignant BD (ie; with in 1cm from the hilum or involving the hilum) strictures and those with distal CBD stricture with duodenal stent in situ occluding access via D 3. Participants are not deemed fit enough to undergo endoscopic drainage, either at ERCP or EUS-BD 4. Distance between bile duct and duodenum lumen >8mm

Design outcomes

Primary

Measure	Time frame
The safety and technical success of placing lumen apposing stents (LAMS) in the drainage of bile duct is assessed by reviewing the endoscopy report, patient notes, blood tests and patient interviews on day 1, 7 and 30 post procedure	—

Secondary

Measure	Time frame
1. Clinical success (i.e. improvement or resolution of jaundice) is assessed using blood tests and patient interviews on day 1, 7 and 3 following EUS guided biliary drainage 2. Procedure-related complications are measured reviewing the endoscopy report, patient notes, blood tests and patient interviews on day 1, 7 and 30 post procedure following EUS guided biliary drainage 3. 30-day mortality is recorded from hospital records following EUS guided biliary drainage 4. Quality of life is measured using patient interviews following EUS guided biliary drainage	—

Measure

Time frame

1. Clinical success (i.e. improvement or resolution of jaundice) is assessed using blood tests and patient interviews on day 1, 7 and 3 following EUS guided biliary drainage 2. Procedure-related complications are measured reviewing the endoscopy report, patient notes, blood tests and patient interviews on day 1, 7 and 30 post procedure following EUS guided biliary drainage 3. 30-day mortality is recorded from hospital records following EUS guided biliary drainage 4. Quality of life is measured using patient interviews following EUS guided biliary drainage

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Countries

England, United Kingdom

Contacts

Public ContactSuresh Vasan Venkatachalapathy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026