Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Japan / NCT06146946
Recruiting Not applicable

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

NCT06146946 · tracked via the Priya Life Science Japan tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Not applicable
Started
2023-12-01
Last updated
2026-09-15

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Dissection of the No.253 lymph nodeOmitting the dissection of the No.253 lymph node

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (8)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting
China-Japan Friendship Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Not Yet Recruiting
Chinese PLA General Hospital Beijing Beijng Not Yet Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing Chaoyang District Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
West China Hospital Sichuan University Chengdu Sichuan Not Yet Recruiting

Other trials for the same condition

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors Active, not recruiting
A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06146946 on ClinicalTrials.gov ↗ ← All trials in Japan