CompletedObservational

Introducing a non-endoscopic diagnostic test into the clinical pathway to identify high-risk patients with Barrett's oesophagus

Heartburn is common, but regular acid reflux can sometimes damage the lining of your food pipe (oesophagus). Over time, this can lead to a condition called Barrett's oesophagus, which slightly increases the risk of cancer. Usually, finding this condition requires an endoscopy, where a camera tube is passed down your throat. This trial investigates a quicker, easier test called Cytosponge. During a short 10-minute visit at a GP surgery or clinic, you swallow a small capsule attached to a thread with water. The capsule dissolves in your stomach to release a tiny sponge. A nurse then gently pulls the sponge out by the thread, collecting cells from your food pipe to be tested in a laboratory. The goal is to detect cell changes early so patients can receive prompt care, while saving many people from needing an uncomfortable hospital endoscopy.

At a glance

Status

Completed

Enrolment target

3,000

Start

01 Jul 2020

Estimated completion

30 Jun 2023

Oesophageal cancer

What is this study about?

Heartburn and acid reflux are very common, but when acid frequently washes back up into the food pipe, it can cause the lining to change. This condition is known as Barrett's oesophagus. While Barrett's is not cancer, it slightly raises the risk of developing food pipe (oesophageal) cancer in the future. Finding these cell changes early means doctors can monitor them closely or treat them before cancer develops.

At present, the standard way to check the food pipe is through an endoscopy. This procedure involves passing a flexible tube with a camera down your throat into your stomach. While endoscopy is very safe and effective, it can feel unpleasant, requires a hospital visit, and often involves long waiting lists.

This study, called Project DELTA, is testing a simpler method called Cytosponge. The Cytosponge is a tiny sponge packed inside a pill-sized capsule with a soft thread attached. You swallow it with a glass of water. After about seven minutes, the capsule dissolves in the stomach, leaving the small sponge. A nurse then gently removes the sponge by pulling the thread. As it moves up the food pipe, it sweeps up a small sample of cells for testing.

Researchers want to see if offering this quick test in GP surgeries and local clinics can spot Barrett's oesophagus sooner. By catching changes early, doctors hope to protect high-risk patients and reduce the number of people who need hospital camera procedures.

Key takeaways

The Cytosponge is a quick, 10-minute 'sponge on a string' test done at your GP surgery or local clinic.
It checks for Barrett's oesophagus, an early cell change linked to regular heartburn that can sometimes lead to cancer.
The test avoids an uncomfortable hospital endoscopy for many patients.
Over 4,000 people have used it safely, with mild sore throat being the main short-term side effect.
Taking part is voluntary and does not replace your routine healthcare support.

Who may be eligible?

You may be able to join this study if you are 50 or older and regularly take prescription medicine for heartburn or acid reflux, or if your GP has referred you to a hospital clinic to investigate indigestion symptoms. You must be able to swallow a standard tablet.

You will not be able to take part if you take regular anti-inflammatory painkillers (such as ibuprofen), or if you have already been diagnosed with Barrett's oesophagus, food pipe cancer, or throat cancer. You are also not eligible if you have had past surgery on your food pipe.

Additionally, people with severe swallowing difficulties caused by a stroke or neurological condition, those with certain liver problems (such as cirrhosis or swollen veins in the food pipe), and people who cannot temporarily stop blood-thinning medicines cannot join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 50 or over.
I regularly take prescription medication for heartburn, acid reflux, or indigestion.
I can swallow a tablet without severe difficulty.
I have not had surgery on my food pipe or been diagnosed with food pipe cancer.
I have not previously been told I have Barrett's oesophagus.
I am able to safely pause blood-thinning medicines if advised by my doctor.

Answer every question to see your result.

What does participation involve?

Taking part involves a single appointment lasting about 10 minutes at your GP surgery or a local clinic. A trained nurse will ask you to swallow the Cytosponge capsule with a glass of water while holding onto the attached thread. You will wait for about seven minutes while the pill dissolves in your stomach. The nurse will then gently pull the thread to remove the sponge, which takes just a few seconds. The sponge is sent to a laboratory, and your results will be ready in a few weeks. If the test cannot collect enough cells, you might be invited for a second test. If the results show signs of Barrett's oesophagus, your doctor will arrange an endoscopy at your local hospital to look more closely. You can return to your normal daily activities immediately after the test.

Potential risks and benefits

Taking part may help doctors spot signs of Barrett's oesophagus early, allowing you to get treatment or monitoring before problems worsen. Over 4,000 people have used the Cytosponge safely. It is not painful, though having it removed can feel unusual. A mild sore throat is common for a day or two afterwards, which usually improves with simple lozenges or paracetamol. Very rarely (less than 1 in 2,000 times), the sponge can come loose from the thread or cause minor bleeding; if this happens, a standard hospital endoscopy is used to remove it safely. Taking part is completely voluntary, and you can withdraw at any time without your regular NHS medical care being affected.

Locations (1)

Cambridge University Hospital
Approximate
Cambridge, England

Common questions

Does swallowing the Cytosponge hurt?

No, it is not painful. The capsule is about the size of a large vitamin tablet and is swallowed with water. When the nurse removes it, you may feel a brief scratching sensation or mild gag reflex, but it is over in a few seconds.

What is Barrett's oesophagus?

Barrett's oesophagus is a condition where the normal cells lining the food pipe change into cells similar to those in the intestine. It is usually caused by long-term acid reflux and slightly increases the risk of cancer.

What happens if my Cytosponge result is positive?

If the laboratory finds cells linked to Barrett's oesophagus or other abnormal changes, you will be invited to your local hospital for an endoscopy to confirm the diagnosis and discuss monitoring or treatment.

Can I eat and drink normally on the day of the test?

Your clinic will give you specific instructions, but you will usually need to avoid eating for a short period before the appointment to make sure your stomach is empty.

What if I try to swallow the capsule and cannot manage it?

If you find it difficult or uncomfortable to swallow the capsule, you can stop at any point. You will continue to receive your usual NHS care and any alternative tests your doctor recommends.

How to find out more

Abigail Kerridge

amk88@mrc-cu.cam.ac.uk +44 (0)7729833450 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.