Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510543
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
Goal-directed Enteral Nutritional Perioperative Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENTLEMAN
Brief Summary:
This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival
Detailed Description:
Severe malnutrition is a significant risk factor for postoperative complications in esophageal cancer patients Early oral nutritional supplementation after surgery can prevent weight loss and improve quality of life The EFFORT trial showed that individual-based enteral nutrition support reduced complications extended 1-year survival and improved quality of life This study aims to assess the safety and effectiveness of individualized perioperative nutrition support guided by daily energy targets in esophageal cancer patients at nutritional risk It also seeks to determine if supplementing immunonutrition can effectively reduce postoperative complications This study was conducted as a multicenter open-label randomized controlled phase 3 trial The experiment group was administered goal-directed enteral nutritional therapy while the control group received conventional enteral nutritional therapy The study observed the participants major pulmonary and other complications within 90 days post-surgery and nutritional status disease-free survival DFS and overall survival OS in both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None