The goal of this clinical trial is to learn about whether it is safe to omit dissectionof the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aimsto answer is that if it is possible to achieve the same long-term survival with andwithout 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 thedissection of the No.253 lymph node.
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.
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.
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.
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.
Peking Union Medical College Hospital
Beijing, Beijing, China
China-Japan Friendship Hospital
Beijing, Beijing, China
Beijing Cancer Hospital
Beijing, Beijing, China
Chinese PLA General Hospital
Beijing, Beijng, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Chaoyang district, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Mingguang Zhang, Dr.
+8613261967603
zmgslimshady@163.com
Qian Liu, Dr.
13601008906
fcwpumch@163.com
Qian Liu, Principal Investigator
Cancer Hospital, Chinese Academy of Medical Science