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AI as a surgical Co-Pilot: predicting difficulty in rectal cancer

NCT ID NCT07761169

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether an AI tool called SurgDiff can predict how difficult rectal cancer surgery will be, based on MRI scans and patient data. The goal is to help surgeons choose the best surgical approach for each patient, potentially reducing complications. The study involves 68 adults with mid-low rectal cancer who are scheduled for surgery. Researchers will compare outcomes between patients whose surgical plan is guided by the AI and those who receive standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-assisted decision-making using the SurgDiff model, which predicts surgical difficulty from MRI scans and clinical data
What this could lead to
If successful, this could help surgeons choose the best surgical approach for rectal cancer, potentially reducing complications and improving outcomes.
What could go wrong
The trial is small (68 participants) and early, so the AI's predictions may not always be accurate or generalizable to all patients. There is also a risk that the model could misjudge difficulty, leading to suboptimal surgical choices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pathological examination confirmed a diagnosis of rectal adenocarcinoma; radical surgery is recommended. 2. The inferior border of the tumor is ≥1 cm from the dentate line and ≤7 cm from the anal verge; 3. Preoperative staging was assessed in a stage of c/ycT1-3N0-2M0; 4. The cardiac, pulmonary, hepatic, renal, and other organ functions are adequate, and the patient can tolerate laparoscopic surgery. Exclusion Criteria: 1. Intraoperative exploration is unable to achieve R0 resection or preservation of the anus; 2. Lateral lymph node dissection is required; 3. Patients with a history of severe mental illness, immune disorders, or those taking hormonal medications; 4. Any other circumstances in which the investigator deems it inappropriate for inclusion.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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