Safety of omitting dissection of specific lymph nodes in rectal cancer surgery

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

This study is testing if skipping the removal of a specific lymph node during rectal cancer surgery is safe and if it can still help patients live just as long.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1384 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT06146946 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety of not dissecting the No.253 lymph nodes during mid and low rectal cancer surgeries. It aims to determine if patients can achieve similar long-term survival rates with or without this dissection. Participants will undergo laparoscopic rectal radical resection, with some having the No.253 lymph node dissection omitted. The study is being conducted across eight medical centers in China to gather robust evidence on this surgical approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed adenocarcinoma of the rectum and specific tumor characteristics.

Not a fit: Patients with a history of malignant colorectal tumors or those with distant metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to less invasive surgical options for rectal cancer patients, potentially improving postoperative quality of life.

How similar studies have performed: While there have been smaller studies on this topic, this trial aims to provide high-level evidence through a larger sample size, making it a significant advancement in the field.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Chinese PLA General Hospital — Beijing, Beijng, China (Not_yet_recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Chaoyang District, China (Recruiting)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Qian Liu — Cancer Hospital Chinese Academy of Medical Science
• Study coordinator: Mingguang Zhang, Dr.

Conditions Rectal Cancer; Rectal cancer; Lymph node dissection; No.253 lymph node