Trial Title:
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
NCT ID:
NCT06146946
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Rectal cancer
Lymph node dissection
No.253 lymph node
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Dissection of the No.253 lymph node
Description:
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.
Arm group label:
Dissection of the No.253 lymph node
Intervention type:
Procedure
Intervention name:
Omitting the dissection of the No.253 lymph node
Description:
In the experimental group, the surgery is performed without dissection of the No.253
lymph node.
Arm group label:
Omitting dissection of the No.253 lymph node
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100021
Country:
China
Contact:
Last name:
Yi Xiao, Dr.
Phone:
13366036387
Investigator:
Last name:
Yi Xiao, Dr.
Email:
Principal Investigator
Facility:
Name:
China-Japan Friendship Hospital
Address:
City:
Beijing
Zip:
100029
Country:
China
Contact:
Last name:
Lei Zhou, Dr.
Phone:
13910279583
Investigator:
Last name:
Lei Zhou, Dr.
Email:
Principal Investigator
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Aiwen Wu, Dr.
Phone:
13911577190
Investigator:
Last name:
Aiwen Wu, Dr.
Email:
Principal Investigator
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100141
Country:
China
Contact:
Last name:
Xiaohui Du, Dr.
Investigator:
Last name:
Xiaohui Du, Dr.
Email:
Principal Investigator
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Contact:
Last name:
Minhua Zheng
Investigator:
Last name:
Minhua Zheng
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Xinxiang Li, Dr.
Investigator:
Last name:
Xinxiang Li
Email:
Principal Investigator
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Contact:
Last name:
Ziqiang Wang, Dr.
Investigator:
Last name:
Ziqiang Wang
Email:
Principal Investigator
Start date:
December 1, 2023
Completion date:
December 1, 2029
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
China-Japan Friendship Hospital
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06146946
