Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146946
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-11-18
Brief Title:
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No253 Lymph Node S-M-O-O-T-H
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No253 Lymph Node a Prospective Multicenter Non-inferior Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No253 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 No253 lymph node in mid and low rectal cancer surgery Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No253 lymph node
Detailed Description:
The No253 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 No253 lymph node The rate of metastasis to the No253 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 No253 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 Peoples 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 No253 lymph node providing high-level evidence-based medical evidence for the implementation of this surgical technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None