PRESERVE

Trial Info

Status: Open

Specialty: Colorectal

Date Opened: 31/10/2025

Planned Close Date: 30/04/2026

Sponsor: Imperial College London

Principal Investigator: Dr Manaswini Choudhary

Study Title: PRESERVE

Trial Description

The PRESERVE trial aims to show that using our MRI reporting system we can substantially reduce the number of patients having major surgery for early rectal cancers (ERC).

Bowel cancer is the UK’s third most common cancer. Major surgery removing a large section of bowel and surrounding tissue is routinely recommended as treatment for rectal cancer as per current guidelines. 1 in 5 patients require a permanent colostomy. It is widely reported by patients that their quality of life (QOL) deteriorates after surgery. It is possible to perform a smaller operation to remove these cancers (local excision) that is curative and does not result in as many complications or deterioration in patients’ QOL.

Although it is been shown that the Bowel Cancer Screening Programme is detecting more ERC, the number of patients undergoing major surgery has not fallen. This is because currently there is no way for clinicians to know which patients are suitable for local excision.

We want to prove our system will be equally accurate in describing ERC so that local excision can be performed safely, ensuring all cancer is removed.

Patients recruited to the study will have an MRI scan reported by a trained radiologist, followed by discussion at a multidisciplinary team meeting. If it is possible to remove the tumour by local excision, then this will be offered to the patient.

Following local excision surgery, patients will be given a score based on the pathology of their tumour. Ongoing follow-up / treatment will be determined by this score:

• Low: surveillance

• Moderate: randomised (1:1 ratio) to surveillance or radiotherapy and surveillance

• High: radiotherapy and surveillance

Patients who undergo traditional surgery for removal of the tumour will undergo surveillance as per current standards.

The feasibility trial will involve the recruitment of 146 patients with ERC at UK sites.

Inclusion Criteria

Patients must have the following inclusion criteria to be considered eligible based on the following MRI features that define early rectal cancer:

• Absence of mrEMVI/mrN1c deposits

• mrT3b tumour or less on initial assessment

• mrCRM clear > 1mm

• Significant polyp or Rectal lesion as defined on MRI/Endoscopy

• Be over 18 years of age

• Of adequate performance status to able to undergo surgery if necessary

Exclusion Criteria

Patients will not be eligible if they fulfil any of the following:

• Are requiring neoadjuvant therapy for MRI staged advanced rectal cancer

• Have metastatic disease

• Have a secondary malignancy where there is < 95% certainty of survival from the treated disease

• Are unable to consent or withhold consent

• Biopsy-proven malignancy which is not adenocarcinoma*

*Patients do not need to have had a biopsy prior to registration. However, if after excision the rectal lesion is found to either not be an adenocarcinoma or be benign, the patient would be withdrawn and replaced in the study.

Contacts

Administrator: Nicole Buck

Link to EDGE

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