Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892289
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-07
First Post:
2023-05-04
Brief Title:
Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique 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:
Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer a Phase II Multi-center Single-arm Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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 The patients have poor nutritional status and quality of life after total gastrectomy Compare to total gastrectomy the nutritional status can improve after proximal gastrectomy But if use simple esophagogastric anastomosis for proximal gastrectomy the incidence of postoperative reflux esophagitis is high 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 condition than total gastrectomy
Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia At present the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine At present some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective and the learning curve is shorter than laparoscopic surgery The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases Two patients recovered well after surgery with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good Now we plan to conduct a multi-center single arm study on proximal early gastric cancer patientsT1N0-1M0 and T2N0M0 to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique and to evaluate the surgical and oncological safety of this surgical method Aim to provide initial evidence of evidence-based medicine for its clinical application
Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia At present the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine At present some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective and the learning curve is shorter than laparoscopic surgery The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases Two patients recovered well after surgery with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good Now we plan to conduct a multi-center single arm study on proximal early gastric cancer patientsT1N0-1M0 and T2N0M0 to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique and to evaluate the surgical and oncological safety of this surgical method Aim to provide initial evidence of evidence-based medicine for its clinical application
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