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

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: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Omitting the dissection of the No.253 lymph node; Procedure: Dissection of the No.253 lymph node

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: Interventional
• Enrollment (Estimated): 1384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingguang Zhang, Dr.; Phone Number: +8613261967603; Email: zmgslimshady@163.com
• Study Contact Backup: Name: Qian Liu, Dr.; Phone Number: 13601008906; Email: fcwpumch@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Not yet recruiting
      • China-Japan Friendship Hospital
      • Contact: Lei Zhou, Dr.; Phone Number: 13910279583
      • Contact: Lei Zhou, Dr.
    • Beijing, Beijing, China, 100142
      • Not yet recruiting
      • Beijing Cancer Hospital
      • Contact: Aiwen Wu, Dr.; Phone Number: 13911577190
      • Contact: Aiwen Wu, Dr.
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yi Xiao, Dr.; Phone Number: 13366036387
      • Contact: Yi Xiao, Dr.
  • Beijng
    • Beijing, Beijng, China, 100141
      • Not yet recruiting
      • Chinese PLA General Hospital
      • Contact: Xiaohui Du, Dr.
  • Chaoyang district
    • Beijing, Chaoyang district, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Qian Liu, M.D.; Phone Number: 13601008906; Email: fcwpumch@163.com
      • Contact: Mingguang Zhang, M.D.; Phone Number: +8613261967603; Email: zmgslimshady@163.com
      • Contact: Qian Liu, M.D.
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xinxiang Li
      • Contact: Xinxiang Li, Dr.
    • Shanghai, Shanghai, China, 200025
      • Not yet recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Minhua Zheng
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Not yet recruiting
      • West China Hospital Sichuan University
      • Contact: Ziqiang Wang, Dr.
      • Contact: Ziqiang Wang

Participation Criteria

Eligibility Criteria

• 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. 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. 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of harvested lymph nodes	Total number of lymph nodes dissected in the pathology report	About 10 days after surgery
Incidence of postoperative complications	The proportion of short-term complications occurring within 30 days post-surgery	30 days after surgery
Intraoperative blood loss	Total blood loss during the surgery	Intraoperative
Operative duration	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	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	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	Overall survival refers to the length of time from the primary treatment that patients are still alive.	3 years after surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Fudan University; Peking Union Medical College Hospital; Chinese PLA General Hospital; West China Hospital; Peking University Cancer Hospital & Institute; Ruijin Hospital; China-Japan Friendship Hospital
• Investigators: Principal Investigator: Qian Liu, Cancer Hospital, Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 18, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Rectal cancer; Lymph node dissection; No.253 lymph node
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID 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