Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890339
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-05-03
Brief Title:
Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer a Multi-center Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-09
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:
Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy But if use simple esophagogastric anastomosis for proximal gastrectomy the incidence of postoperative reflux esophagitis is up to 62 which seriously affects the quality of life and the short-term outcome is poorer than the total gastrectomy If the incidence of postoperative reflux esophagitis can be reduced proximal gastrectomy would be the treatment choice for proximal early gastric cancer which may more improve both quality of life and nutritional status than total gastrectomy
Double-flap technique is a new surgical procedure for the reconstruction between esophagus and remnant stomach which was started to be applied to digestive tract reconstruction in patients with proximal early gastric cancer in 2016 It can reduce the occurrence of reflux oesophagitis At present the studies for double-flap technique in China and other countries are mostly retrospective studies and there are short of large-scale prospective studies and evidence of evidence-based medicine
The applicant has initiated a phase II single center single arm study and the results suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction technique was safe and effective for treating proximal early gastric cancer To further validate the short and long-term outcomes of this procedure a multicentre open label prospective superiority and randomised controlled clinical trial was set up to compare laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer It include 216 patients with proximal early gastric cancer The primary outcome is the proportion of patients who develop reflux esophagitis within 12 months after surgery The short and long-term oncological outcomes are also explored This trial can provide high-grade evidence of evidence-based medicine for double-flap techniques clinical applications
Double-flap technique is a new surgical procedure for the reconstruction between esophagus and remnant stomach which was started to be applied to digestive tract reconstruction in patients with proximal early gastric cancer in 2016 It can reduce the occurrence of reflux oesophagitis At present the studies for double-flap technique in China and other countries are mostly retrospective studies and there are short of large-scale prospective studies and evidence of evidence-based medicine
The applicant has initiated a phase II single center single arm study and the results suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction technique was safe and effective for treating proximal early gastric cancer To further validate the short and long-term outcomes of this procedure a multicentre open label prospective superiority and randomised controlled clinical trial was set up to compare laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer It include 216 patients with proximal early gastric cancer The primary outcome is the proportion of patients who develop reflux esophagitis within 12 months after surgery The short and long-term oncological outcomes are also explored This trial can provide high-grade evidence of evidence-based medicine for double-flap techniques clinical applications
Detailed Description:
None
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