Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03600584
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-07-03
Brief Title:
Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
Sponsor:
Nanjing Medical University
Organization:
Nanjing Medical University
Study Overview
Official Title:
Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
NOT_YET_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:
None
Brief Summary:
The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy
Detailed Description:
Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy with comparable incidence rate of pancreatic fistula PF We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ The aim of this study is to examine if the investigators modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ
This trial is a single-center randomized controlled patient- and observer- blinded study whose primary aim is to assess whether a modified duct-to-mucosa PJ trial group is superior to an invagination PJ control group in terms of clinically relevant PF and other complications A total of 380 patients who are to undergo elective PD will be recruited and randomized intraoperatively into either of the two groups The primary efficacy endpoint is the incident rate of clinically relevant PF Secondary outcome measures are entry into adjuvant therapy mortality surgical complications non-surgical complications hospital stay Patients will be followed up for 3 months Statistical analysis will be based on the intention-to-treat population The duration of the entire trial is estimated to be two years
This trial is a single-center randomized controlled patient- and observer- blinded study whose primary aim is to assess whether a modified duct-to-mucosa PJ trial group is superior to an invagination PJ control group in terms of clinically relevant PF and other complications A total of 380 patients who are to undergo elective PD will be recruited and randomized intraoperatively into either of the two groups The primary efficacy endpoint is the incident rate of clinically relevant PF Secondary outcome measures are entry into adjuvant therapy mortality surgical complications non-surgical complications hospital stay Patients will be followed up for 3 months Statistical analysis will be based on the intention-to-treat population The duration of the entire trial is estimated to be two years
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