Rectal CancerNCT07761169
Randomized Controlled Trial of the SurgDiff Model for Predicting Surgical Difficulty to Help Choose Approach in Mid-Low Rectal Cancer
A study testing AI-assisted decision-making in people with Rectal Cancer, run by Peking Union Medical College Hospital.
Trial summary
This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- AI-assisted decision-making
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological examination confirmed a diagnosis of rectal adenocarcinoma; radical surgery is recommended.
- The inferior border of the tumor is ≥1 cm from the dentate line and ≤7 cm from the anal verge;
- Preoperative staging was assessed in a stage of c/ycT1-3N0-2M0;
- The cardiac, pulmonary, hepatic, renal, and other organ functions are adequate, and the patient can tolerate laparoscopic surgery.
Who cannot join
- Intraoperative exploration is unable to achieve R0 resection or preservation of the anus;
- Lateral lymph node dissection is required;
- Patients with a history of severe mental illness, immune disorders, or those taking hormonal medications;
- Any other circumstances in which the investigator deems it inappropriate for inclusion.
About this study
This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.
- Conditions
- Rectal Cancer
- Being tested
- AI-assisted decision-making
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted decision-makingProcedure or surgery
The SurgDiff model performs a difficulty assessment based on the patient's preoperative MRI scans and clinical data, thereby assisting the surgeon in formulating the surgical plan
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The SurgDiff model performs a difficulty assessment based on the patient's preoperative MRI scans and clinical data, thereby assisting the surgeon in formulating the surgical plan. Receives: Procedure: AI-assisted decision-making |
| control group | No intervention | The surgeon selects the surgical approach and performs the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesorectal incomplete rate
Measured: 2 weeks after surgery
Secondary outcomes (2)
Operative conversion rate
Defined as the proportion of cases where laparoscopic total mesoresection (laTME) was converted to open total mesoresection (taTME), or where taTME was converted back to laTME, or where conversion occurred to an open surgical approach during the procedure.
Measured: during the surgery
Positive resection margin rate
defined as the presence of cancer cells on the distal rectal resection margin
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIAO Yi, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761169
- Sponsor's protocol ID
- SurgDiff-01
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the SurgDiff Model for Predicting Surgical Difficulty to Help Choose Approach in Mid-Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT07761169
- Acronym / sponsor ID
- SurgDiff-01
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: AI-assisted decision-makingThe SurgDiff model performs a difficulty assessment based on the patient's preoperative MRI scans and clinical data, thereby assisting the surgeon in formulating the surgical plan. |
| control group | No intervention | –The surgeon selects the surgical approach and performs the procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathological examination confirmed a diagnosis of rectal adenocarcinoma; radical surgery is recommended.
- The inferior border of the tumor is ≥1 cm from the dentate line and ≤7 cm from the anal verge;
- Preoperative staging was assessed in a stage of c/ycT1-3N0-2M0;
- The cardiac, pulmonary, hepatic, renal, and other organ functions are adequate, and the patient can tolerate laparoscopic surgery.
Key exclusion criteria (4 listed)
- Intraoperative exploration is unable to achieve R0 resection or preservation of the anus;
- Lateral lymph node dissection is required;
- Patients with a history of severe mental illness, immune disorders, or those taking hormonal medications;
- Any other circumstances in which the investigator deems it inappropriate for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted decision-makingThe SurgDiff model performs a difficulty assessment based on the patient's preoperative MRI scans and clinical data, thereby assisting the surgeon in formulating the surgical plan | Procedure or surgery | experimental group |
Primary outcome
Mesorectal incomplete rate
Time frame: 2 weeks after surgery
2 secondary outcomes
Operative conversion rate
Time frame: during the surgery
Positive resection margin rate
Time frame: 2 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted decision-making in people with Rectal Cancer, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesorectal incomplete rate (time frame: 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.