Recruiting nowNot phasedRandomised
| Registry number | NCT06146946 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 1,384 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Dissection of the No.253 lymph node
- Procedure Omitting the dissection of the No.253 lymph node
What it is measuring
3-year disease free survival rate
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers think that removing the No. 253 lymph nodes may not be necessary for some people having laparoscopic surgery for mid- or low-rectal cancer. The trial is testing whether leaving these nodes in place gives similar cancer control to surgery that includes their removal.
If omitting the dissection is as safe, it could spare patients part of the operation while maintaining 3-year disease-free survival—the time without signs that the cancer has returned or progressed. The comparison is surgery with versus without No. 253 lymph-node dissection.
Worth knowing: The main measure is disease-free survival at three years, not overall survival, and the record does not specify whether omitting the dissection reduces surgical complications.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Rectal
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Patient age between 18-75 years.
2. Colonic biopsy pathology confirms adenocarcinoma.
3. At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
4. At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
5. At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
6. At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
7. Strong willingness for surgery and signed informed consent.
Exclusion Criteria
1. Previous history of malignant colorectal tumors.
2. Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.
3. Imaging diagnosis of distant metastasis.
4. Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.
5. Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
6. Extensive lesions not amenable to R0 resection.
7. Diagnosed with other malignancies within the past five years.
8. ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2.
9.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 8 sites. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06146946, registered by Cancer Institute and Hospital, Chinese Academy of Medical Sciences on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.