Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279299
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-19
Brief Title:
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
Sponsor:
National Cancer Center China
Organization:
National Cancer Center China
Study Overview
Official Title:
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
Status:
RECRUITING
Status Verified Date:
2024-02
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 purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms rNENs undergoing laparoscopic total mesenteric excision TME The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME necessitating concurrent lateral Pelvic lymph node dissection
Detailed Description:
This study is a prospective single-arm clinical study 30 patients with rNENs undergoing TME are planned to be included in the study The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rNENs undergoing laparoscopic TME The primary endpoint is the rate of lateral pelvic lymph nodes metastasis The primary hypothesis was the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME necessitating concurrent lateral Pelvic lymph node dissection
This study seeks to report for the first time the true status of lateral pelvic lymph node metastasis in these patients In addition the proportion of patients with radical resection R0 surgical complication profile and quality of life QoL are also secondary endpoints
This study seeks to report for the first time the true status of lateral pelvic lymph node metastasis in these patients In addition the proportion of patients with radical resection R0 surgical complication profile and quality of life QoL are also secondary endpoints
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