Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135012
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-07-03
Brief Title:
Influence of Pancreatic Transection With CUSA on Postoperative Pancreatic Fistula Incidence PANCUT
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Influence of Pancreatic Transection With Cavitron Ultrasonic Surgical Aspirator CUSA on Postoperative Pancreatic Fistula Incidence - a Prospective Randomised Controlled Trial the PANCUT Study
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PANCUT
Brief Summary:
Objective To compare the outcomes after elective pancreatic resections using cavitron ultrasonic surgical aspirator CUSA and selective closure of small blood vessels and branch pancreatic ducts versus surgical scalpel or stapler for the transection of pancreatic tissue
Study design A randomized controlled single centre trial
Study population Two groups of 80 patients 160 in total scheduled for elective open pancreaticoduodenectomy PD for any indication
Intervention Transection of pancreatic tissue with CUSA
Control Standard transection of pancreatic tissue with surgical scalpel in PD or stapler in DP
Study design A randomized controlled single centre trial
Study population Two groups of 80 patients 160 in total scheduled for elective open pancreaticoduodenectomy PD for any indication
Intervention Transection of pancreatic tissue with CUSA
Control Standard transection of pancreatic tissue with surgical scalpel in PD or stapler in DP
Detailed Description:
Rationale Postoperative pancreatic fistula POPF is one of the major causes of morbidity and mortality after pancreatic resections There is no predominant surgical technique of pancreatic stump closure in distal pancreatectomy DP or formation of pancreaticojejunostomy in pancreaticoduodenectomy PD proven to preventlower POPF incidence Cavitron ultrasonic surgical aspirator CUSA selectively removes tissue parenchyma evading blood vessels and pancreatic ducts which could consequently be selectively ligated Such technique could anull pancreatic juice drainage from branch ducts and provide better skeletonised view of the main duct to from an anastomosis or to ligate it in DP and thus lower the incidence of POPF formation
Objective To compare transection of pancreatic tissue with CUSA and selective closure of small blood vessels and branch pancreatic ducts with transection with surgical scalpel or stapler in elective pancreatic resections regarding the incidence of POPF
Study design A randomized controlled single centre trial The study protocol was designed according to the SPIRIT guidelines
Study population Two groups of 80 patients 160 in total scheduled for elective open pancreaticoduodenectomy PD for any indication
Intervention Transection of pancreatic tissue with CUSA
Control Standard transection of pancreatic tissue with surgical scalpel in PD
Main study parametersendpoints Primary outcome is the incidence of POPF Main secondary outcomes are intraoperative outcomes such as blood loss and operative time postoperative outcomes such as complications time to functional recovery and hospital stay
Objective To compare transection of pancreatic tissue with CUSA and selective closure of small blood vessels and branch pancreatic ducts with transection with surgical scalpel or stapler in elective pancreatic resections regarding the incidence of POPF
Study design A randomized controlled single centre trial The study protocol was designed according to the SPIRIT guidelines
Study population Two groups of 80 patients 160 in total scheduled for elective open pancreaticoduodenectomy PD for any indication
Intervention Transection of pancreatic tissue with CUSA
Control Standard transection of pancreatic tissue with surgical scalpel in PD
Main study parametersendpoints Primary outcome is the incidence of POPF Main secondary outcomes are intraoperative outcomes such as blood loss and operative time postoperative outcomes such as complications time to functional recovery and hospital stay
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