ENCOMPASS version 1.1
Research type
Research Study
Full title
A Randomized Controlled Trial Evaluating Lung Nodules — COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
IRAS ID
367520
Contact name
Ricky Thakrar
Contact email
Sponsor organisation
Intuitive Surgical sàrl
Clinicaltrials.gov Identifier
73092, Central Portfolio management system
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Doctors may need to remove a small tissue sample (called a biopsy) from a lung nodule to determine whether it is cancerous or non‑cancerous. There are two commonly used procedures to do this. One involves passing a needle through the chest wall using CT scans for guidance (CT‑guided percutaneous biopsy). The other involves passing small instruments through the airways using the shape‑sensing robotic‑assisted bronchoscopy system, sometimes supported by cone‑beam CT imaging (ssRAB with CBCT). Both methods are routinely used in NHS and other European hospitals.
The ENCOMPASS study aims to compare these two standard biopsy methods to see how they perform in routine clinical practice, including how often they provide a clear diagnosis. Although both techniques are widely used, there has not been a randomised study directly comparing them.
Adults who are already scheduled to have a lung nodule biopsy as part of their normal care may be invited to take part. Participants will be randomly allocated to one of the two biopsy approaches. If the clinical team decides that the allocated method is not suitable, the patient will receive the most appropriate standard care instead.
The study does not involve any experimental treatments or procedures. No extra invasive tests or scans are required beyond usual care. Participants will be followed for up to 14 months post-procedure using information from their medical records. Participants will be asked to complete a short health‑related quality‑of‑life questionnaire (EQ‑5D‑5L) at several time points. An additional questionnaire about work status is optional.
Taking part in the study will not affect a participant’s access to treatment or ongoing care. Participation is voluntary, and individuals may withdraw at any time without giving a reason. The information collected will help doctors understand how these biopsy methods compare in real‑world practice and may improve future care for people with lung nodules.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
26/LO/0431
Date of REC Opinion
2 Jul 2026
REC opinion
Further Information Favourable Opinion