Ignite Creation Date:
2024-05-06 @ 12:33 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03785743
Status:
RECRUITING
Last Update Posted:
2022-03-02
First Post:
2018-12-20
Brief Title:
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic CarcinomaTJDBPS07 a Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-02
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:
Background Pancreatic cancer PC is one of the most aggressive malignant neoplasms with poor outcomes Pancreatoduodenectomy PD is the only curative treatment for PC Minimally invasive surgery has been progressively developed first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries but a number of issues are currently being debated including the superiority between total laparoscopic pancreaticoduodenectomy TLPDand the open pancreaticoduodenectomy OPD Studies comparing these two surgery techniques are merging and randomized controlled trials RCT are lacking but clearly required
Methodsdesign TJDBPS07 is a multicenter prospective randomized controlled trial comparing TLPD and OPD in pancreatic cancers A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery ERAS pattern The trials aim is to exploring the overall survival OS disease free survival DFS and quality of life The duration of the entire trial is seven years including prearrangement a presumably five-year follow-up and analyses
Discussion Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy MIPD and Open approach or LPD versus OPD This trial will be the first comparing TLPD and OPD in a large multicenter setting TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects
Methodsdesign TJDBPS07 is a multicenter prospective randomized controlled trial comparing TLPD and OPD in pancreatic cancers A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery ERAS pattern The trials aim is to exploring the overall survival OS disease free survival DFS and quality of life The duration of the entire trial is seven years including prearrangement a presumably five-year follow-up and analyses
Discussion Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy MIPD and Open approach or LPD versus OPD This trial will be the first comparing TLPD and OPD in a large multicenter setting TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects
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