Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347757
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-03-29
Brief Title:
A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy
Sponsor:
Northern Jiangsu Peoples Hospital
Organization:
Northern Jiangsu Peoples Hospital
Study Overview
Official Title:
A 3-Arm Study Comparing the Efficacy of Anti-Reflux Alimentary Reconstruction Protocols Single-Tract Jejunal Interposition vs Double Tract vs Tube-Like Stomach Reconstruction After Laparoscopic Proximal Gastrectomy
Status:
COMPLETED
Status Verified Date:
2024-03
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 efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective multicenter randomized controlled trial
Detailed Description:
In the trial 180 patients with early upper-third early gastric cancer and Siewert type IIIII esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups Group A single-tract jejunal interposition n 60 Group B double-tract reconstruction n 60 or Group C tube-like stomach reconstruction n 60 The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis operative time intraoperative blood loss quality of life overall survival and disease-free survival Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ 30-item core questionnaire C30 and the EORTC QLQ stomach cancer-specific questionnaire at 3 months 12 months and 24 months
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