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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06146946

Enrollment

1384

Registered

2023-11-27

Start date

2023-12-01

Completion date

2029-12-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal cancer, Lymph node dissection, No.253 lymph node

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.

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.

Interventions

PROCEDUREDissection 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.

PROCEDUREOmitting the dissection of the No.253 lymph node

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
3-year disease free survival rate	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.

Secondary

Measure	Time frame	Description
Number of harvested lymph nodes	About 10 days after surgery	Total number of lymph nodes dissected in the pathology report
Incidence of postoperative complications	30 days after surgery	The proportion of short-term complications occurring within 30 days post-surgery
Intraoperative blood loss	Intraoperative	Total blood loss during the surgery
Operative duration	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)
Postoperative urination and sexual function	1 year after surgery	Three months, six months, and one year postoperatively, evaluate patients' urinary and sexual functions using scales.
3-year local recurrence rate	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-year overall survival rate	3 years after surgery	Overall survival refers to the length of time from the primary treatment that patients are still alive.
Rate of conversion to open surgery	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.

Countries

China

Contacts

CONTACTMingguang Zhang, Dr.

zmgslimshady@163.com+8613261967603

CONTACTQian Liu, Dr.

fcwpumch@163.com13601008906

PRINCIPAL_INVESTIGATORQian Liu

Cancer Hospital Chinese Academy of Medical Science

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026