Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT02936193
Status:
UNKNOWN
Last Update Posted:
2019-11-05
First Post:
2016-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
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:
LAPPG
Brief Summary:
The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.
Detailed Description:
During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured
Study Oversight
Has Oversight DMC:
True
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?: