Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

August 28, 2026 updated by: QIAN LIU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The No.253 lymph node, as the third station in the inferior mesenteric artery lymphatic system, plays a significant role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They act as the last barrier for tumor metastasis from the regional to distant areas. However, there is still controversy regarding whether rectal cancer patients universally require dissection of the No.253 lymph node. The rate of metastasis to the No.253 lymph node in rectal cancer patients is extremely low, and dissection may not bring survival benefits. Additionally, postoperative urinary and sexual functions may be impaired due to damage to the sympathetic nerves. However, current prospective randomized controlled trials on the safety of omitting the dissection of the No.253 lymph node have small sample sizes and lack sufficient test power. Further confirmation is needed from large-sample prospective randomized controlled studies. Based on this, the investigator plans to collaborate with Peking Union Medical College Hospital, China-Japan Friendship Hospital, Chinese People's Liberation Army General Hospital, Shanghai Ruijin Hospital, Fudan Cancer Hospital, and West China Hospital of Sichuan University, totaling eight medical centers, to conduct a prospective randomized controlled study. This study aims to confirm the safety of mid and low rectal surgery without dissection of the No.253 lymph node, providing high-level evidence-based medical evidence for the implementation of this surgical technique.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Aiwen Wu, Dr.
          • Phone Number: 13911577190
        • Principal Investigator:
          • Aiwen Wu, Dr.
      • Beijing, Beijing Municipality, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Lei Zhou, Dr.
          • Phone Number: 13910279583
        • Principal Investigator:
          • Lei Zhou, Dr.
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Yi Xiao, Dr.
          • Phone Number: 13366036387
        • Principal Investigator:
          • Yi Xiao, Dr.
    • Beijng
      • Beijing, Beijng, China, 100141
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Xiaohui Du, Dr.
        • Principal Investigator:
          • Xiaohui Du, Dr.
    • Chaoyang District
      • Beijing, Chaoyang District, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qian Liu, M.D.
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Xinxiang Li, Dr.
        • Principal Investigator:
          • Xinxiang Li
      • Shanghai, Shanghai Municipality, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Minhua Zheng
        • Principal Investigator:
          • Minhua Zheng
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Not yet recruiting
        • West China Hospital Sichuan University
        • Contact:
          • Ziqiang Wang, Dr.
        • Principal Investigator:
          • Ziqiang Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient age between 18-75 years.
  2. Colonic biopsy pathology confirms adenocarcinoma.
  3. The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis.
  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. Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery.
  10. History of severe mental illness.
  11. Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Omitting dissection of the No.253 lymph node
Perform surgery based on the principle of Total Mesorectal Excision (TME), without denuding the root of the Inferior Mesenteric Artery (IMA) and without dissection of the No.253 lymph node. Ligation of the IMA is performed at a low position distal to the origin of the left colonic artery.
Procedure: Omitting the dissection of the No.253 lymph node
In the experimental group, the surgery is performed without dissection of the No.253 lymph node.
Active Comparator: Dissection of the No.253 lymph node
Perform surgery based on the principle of Total Mesorectal Excision (TME). During the procedure, fully expose the root of the Inferior Mesenteric Artery (IMA), thoroughly dissect the No.253 lymph node, and perform a high ligation along the artery at the root of the IMA; or expose the bifurcation of the left colonic artery, ligating the IMA at a low position distal to the origin of the left colonic artery, ensuring the dissection of the No. 253 lymph node while preserving the left colonic artery.
Procedure: Dissection of the No.253 lymph node
The range of the No.253 lymph node is as follows: medially, it extends from the root of the inferior mesenteric artery to the starting section of the left colonic artery; caudally, from the starting point of the left colonic artery to the intersection with the inferior mesenteric vein; laterally, it is bordered by the outer margin of the inferior mesenteric vein; and cranially, from the horizontal section of the duodenum to the beginning of the jejunum. In the controlled group, the surgery is performed with dissection of the No.253 lymph node.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-year disease free survival rate
Time Frame: 3 years after surgery
Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.
3 years after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of harvested lymph nodes
Time Frame: About 10 days after surgery
Total number of lymph nodes dissected in the pathology report
About 10 days after surgery
Incidence of postoperative complications
Time Frame: 30 days after surgery
The proportion of short-term complications occurring within 30 days post-surgery
30 days after surgery
Intraoperative blood loss
Time Frame: Intraoperative
Total blood loss during the surgery
Intraoperative
Operative duration
Time Frame: Intraoperative
total time spent performing a surgical procedure. This time is typically measured from the moment the surgery begins (marked by the initial incision) to its conclusion (marked by the closure of the surgical wound)
Intraoperative
Postoperative urination and sexual function
Time Frame: 1 year after surgery
Three months, six months, and one year postoperatively, evaluate patients' urinary and sexual functions using scales.
1 year after surgery
3-year local recurrence rate
Time Frame: 3 years after surgery
Local recurrence refers to the return of cancer in the same area where it originally developed, typically after treatment has been completed.
3 years after surgery
3-year overall survival rate
Time Frame: 3 years after surgery
Overall survival refers to the length of time from the primary treatment that patients are still alive.
3 years after surgery
Rate of conversion to open surgery
Time Frame: From initial skin incision to skin closure at the conclusion of the index operation (full intraoperative period).
The proportion of patients assigned to laparoscopic colorectal resection who require unplanned conversion to open laparotomy during the index surgery. Conversion is defined as abandonment of the planned laparoscopic approach and performance of open laparotomy due to intraoperative circumstances including uncontrollable hemorrhage, severe pelvic/abdominal adhesions, iatrogenic organ or vascular injury, inadequate surgical visualization, or inability to achieve oncologically complete resection via the laparoscopic route. The conversion rate is calculated as the number of converted cases divided by the total number of patients in the assigned laparoscopic group.
From initial skin incision to skin closure at the conclusion of the index operation (full intraoperative period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Cancer Hospital
Shanxi Province Cancer Hospital
Fudan University
Beijing Friendship Hospital
Peking Union Medical College Hospital
Peking University Cancer Hospital & Institute
Shanghai 10th People's Hospital
Shandong Provincial Hospital
Tianjin Medical University Cancer Institute and Hospital
Beijing Chao Yang Hospital
China-Japan Friendship Hospital
The First Hospital of Jilin University
Qianfoshan Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
First Hospital of China Medical University
First Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital of Shanxi Medical University
Huizhou Municipal Central Hospital
First Affiliated Hospital of Chongqing Medical University
Guangdong Second Provincial General Hospital
Subei People's Hospital of Jiangsu Province
Yunnan Cancer Hospital
Affiliated Hospital of Qinghai University
The Fourth Affiliated Hospital of Harbin Medical University
Liaoning Cancer Hospital & Institute
Yuncheng Central Hospital
Army Medical Center of PLA
Second Affiliated Hospital, Zhejiang University, School of Medicine
The Sixth Hospital of Shanxi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qian Liu, Cancer Hospital Chinese Academy of Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCC4278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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