NCT06146946

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,384

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Dec 2023Dec 2029

First Submitted

Initial submission to the registry

November 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

November 18, 2023

Last Update Submit

March 24, 2025

Conditions

Rectal Cancer

Keywords

Rectal cancerLymph node dissectionNo.253 lymph node

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival rate

    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 Outcomes (7)

  • Number of harvested lymph nodes

    About 10 days after surgery

  • Incidence of postoperative complications

    30 days after surgery

  • Intraoperative blood loss

    Intraoperative

  • Operative duration

    Intraoperative

  • Postoperative urination and sexual function

    1 year after surgery

  • +2 more secondary outcomes

Study Arms (2)

Omitting dissection of the No.253 lymph node

EXPERIMENTAL

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

Dissection of the No.253 lymph node

ACTIVE COMPARATOR

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

Interventions

Dissection of the No.253 lymph nodePROCEDURE

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.

Dissection of the No.253 lymph node
Omitting the dissection of the No.253 lymph nodePROCEDURE

In the experimental group, the surgery is performed without dissection of the No.253 lymph node.

Omitting dissection of the No.253 lymph node

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age between 18-75 years.
  • Colonic biopsy pathology confirms adenocarcinoma.
  • At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
  • At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
  • At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
  • At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
  • Strong willingness for surgery and signed informed consent.

You may not qualify if:

  • Previous history of malignant colorectal tumors.
  • Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.
  • Imaging diagnosis of distant metastasis.
  • Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.
  • Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
  • Extensive lesions not amenable to R0 resection.
  • Diagnosed with other malignancies within the past five years.
  • ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2.
  • Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery.
  • History of severe mental illness.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Chinese PLA General Hospital

Beijing, Beijng, 100141, China

NOT YET RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Chaoyang District, 100021, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610044, China

NOT YET RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Qian Liu

    Cancer Hospital Chinese Academy of Medical Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingguang Zhang, Dr.

CONTACT

+8613261967603zmgslimshady@163.com

Qian Liu, Dr.

CONTACT

13601008906fcwpumch@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2023

First Posted

November 27, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2029

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(8)