Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511609
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique Kamikawa Anastomosis Versus Double-tract Reconstruction A Prospective Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study is a multicenter open-label prospective randomized parallel-controlled trial The purpose is to explore whether the incidence rate of reflux esophagitis RE within 12 months after surgery is non-inferior for the DFT group compared to the DTR group
Detailed Description:
This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy The patients will be randomly divided into two groups One group will undergo laparoscopic proximal gastrectomy with double-flap technique DFT anastomosis while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction DTR The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery The secondary endpoints include postoperative complications surgery-related indicators and postoperative nutritional status
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