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

Not Applicable

Completed

• Conditions: Malignant common bile duct obstruction; Cancer

• Registration Number: ISRCTN13196704
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

2021 Results article in https://doi.org/10.1016/j.gie.2021.01.029 (added 02/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-16
• Study Completion: 2020-04-01
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 3. 30-day mortality is recorded from hospital records following EUS guided biliary drainage<br> 4. Quality of life is measured using patient interviews following EUS guided biliary drainage<br>