Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468917
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-16
Brief Title:
First-day Versus Early Drain Removal Following PD a Randomized Controlled Trial
Sponsor:
Casa di Cura Dott Pederzoli
Organization:
Casa di Cura Dott Pederzoli
Study Overview
Official Title:
First-day Versus Early Drain Removal Following Pancreaticoduodenectomy a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
FIDEL
Brief Summary:
Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula POPF with variable impact on clinical outcome Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity The optimal timing for drain removal after PD is still a subject of debate most studies have shown that outcomes are best when ID are removed in postoperative day POD 3 when POPF is excluded
AIM we aim to compare postoperative surgical outcomes after PD in patients with lowmedium risk for POPF ISGPS risk class A-B-C who undergo POD1 drains removal versus POD3 removal
Primary aim 1 grade BC POPF 2 post-pancreatectomy hemorrhage PPH Secondary aims occurrence of fluid collection sepsis SSI need for reintervention length of stay CD3 90 days mortality re-admission
Study Design
This is a randomized controlled open-label study All patients will be randomized on POD1 using computer-generated randomization codes
Group A Drain removal on POD 1 in case of POD 1 DFA 300 UL Group B Drain removal on POD 3 in case of POD 1 DFA 300 UL
AIM we aim to compare postoperative surgical outcomes after PD in patients with lowmedium risk for POPF ISGPS risk class A-B-C who undergo POD1 drains removal versus POD3 removal
Primary aim 1 grade BC POPF 2 post-pancreatectomy hemorrhage PPH Secondary aims occurrence of fluid collection sepsis SSI need for reintervention length of stay CD3 90 days mortality re-admission
Study Design
This is a randomized controlled open-label study All patients will be randomized on POD1 using computer-generated randomization codes
Group A Drain removal on POD 1 in case of POD 1 DFA 300 UL Group B Drain removal on POD 3 in case of POD 1 DFA 300 UL
Detailed Description:
Introduction Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula POPF with variable impact on clinical outcome fluid collection and hemorrhage For such reason the intraoperative placement of intra-abdominal drains ID to early detect mitigate and manage post-operative complications is still considered to be a routine practice
Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity as well as prolonged hospital stay According to Conlon et al the presence of drains failed to reduce either the need for interventional radiologic drainage or surgical exploration for intraabdominal sepsis and was associated with the development of more intra-abdominal abscesses collections or fistulas Some authors report significantly higher postoperative abdominal complications after late removal of ID A prolonged period of drain insertion is associated with a higher rate of postoperative complications with increased hospital stay and costs not to mention that dislocation of intra-abdominal drains is an early and frequent event after major pancreatic resection
The optimal timing for drain removal after PD is still a subject of debate most studies have shown that outcomes are best when ID are removed in postoperative day POD 3 when POPF is excluded given a specific cut off for drain fluid amylase DFA
Even though many authors advocate early ID removal to prevent intra-abdominal infection or fistula in clinical practice many surgeons may feel more comfortable to maintain IDs for a prolonged period more than 3 days even when criteria for POPF or other abdominal complications are not met
In some studies correlation between drain fluid amylase DFA in POD1 after pancreatic resections and development of POPF has been examined defining ideal cut-off points ranging between 5000UL and 90 Ul3-17-20-21 depending on intraoperative risk stratification that can be used to achieve the best timing for drain removal
AIM In this non-inferiority study we aim to compare postoperative surgical outcomes after PD in patients with lowmedium risk for POPF ISGPS risk class A-B-C who undergo POD1 drains removal versus POD3 removal
Primary aim occurrence of one or more pancreas-specific complications defined according to ISGPS as1 grade BC POPF 2 post-pancreatectomy hemorrhage PPH
Secondary aims occurrence of fluid collection sepsis SSI need for reintervention length of stay CD3 90 days mortality re-admission
Patients and Methods
Study Design
This is a randomized controlled open-label study The Study will be registered in the International Standard Randomized Controlled Trial Registry
All patients encountering inclusion criteria will be randomized on POD1 using computer-generated randomization codes
Group A Drain removal on POD 1 in case of POD 1 DFA 300 UL Group B Drain removal on POD 3 in case of POD 1 DFA 300 UL
Operative technique and drains positioning
Experienced pancreatic surgeons will be performing a standard pancreaticoduodenectomy pylorus-preserving and a Whipple procedure if lesion infiltrates the duodenum After resection anastomoses will be constructed on a single jejunal loop Management of pancreatic stump consisting in single- or double-layer end-to-side pancreatojejunostomy PJ with non-absorbable interrupted sutures Given the low risk for pancreatic fistula no externalized trans-anastomotic stent will be placed End-to-side hepaticojejunostomy will be performed 20 cm distally to PJ with absorbable continuous or interrupted sutures and end-to side duodenojejunostomy with absorbable interrupted sutures Two perianastomotic open passive penrose Easyflow drains are placed at the end of the procedure close to biliary anastomosis and close to PJ anastomosis15
In conclusion we aim through this randomized trial to demonstrate that POD1 drains removal after PD is not inferior to POD3 removal in low and medium risk patients and moreover it could prevent delayed removal-related complications helping to guide post-operative care and improve patient outcomes
Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity as well as prolonged hospital stay According to Conlon et al the presence of drains failed to reduce either the need for interventional radiologic drainage or surgical exploration for intraabdominal sepsis and was associated with the development of more intra-abdominal abscesses collections or fistulas Some authors report significantly higher postoperative abdominal complications after late removal of ID A prolonged period of drain insertion is associated with a higher rate of postoperative complications with increased hospital stay and costs not to mention that dislocation of intra-abdominal drains is an early and frequent event after major pancreatic resection
The optimal timing for drain removal after PD is still a subject of debate most studies have shown that outcomes are best when ID are removed in postoperative day POD 3 when POPF is excluded given a specific cut off for drain fluid amylase DFA
Even though many authors advocate early ID removal to prevent intra-abdominal infection or fistula in clinical practice many surgeons may feel more comfortable to maintain IDs for a prolonged period more than 3 days even when criteria for POPF or other abdominal complications are not met
In some studies correlation between drain fluid amylase DFA in POD1 after pancreatic resections and development of POPF has been examined defining ideal cut-off points ranging between 5000UL and 90 Ul3-17-20-21 depending on intraoperative risk stratification that can be used to achieve the best timing for drain removal
AIM In this non-inferiority study we aim to compare postoperative surgical outcomes after PD in patients with lowmedium risk for POPF ISGPS risk class A-B-C who undergo POD1 drains removal versus POD3 removal
Primary aim occurrence of one or more pancreas-specific complications defined according to ISGPS as1 grade BC POPF 2 post-pancreatectomy hemorrhage PPH
Secondary aims occurrence of fluid collection sepsis SSI need for reintervention length of stay CD3 90 days mortality re-admission
Patients and Methods
Study Design
This is a randomized controlled open-label study The Study will be registered in the International Standard Randomized Controlled Trial Registry
All patients encountering inclusion criteria will be randomized on POD1 using computer-generated randomization codes
Group A Drain removal on POD 1 in case of POD 1 DFA 300 UL Group B Drain removal on POD 3 in case of POD 1 DFA 300 UL
Operative technique and drains positioning
Experienced pancreatic surgeons will be performing a standard pancreaticoduodenectomy pylorus-preserving and a Whipple procedure if lesion infiltrates the duodenum After resection anastomoses will be constructed on a single jejunal loop Management of pancreatic stump consisting in single- or double-layer end-to-side pancreatojejunostomy PJ with non-absorbable interrupted sutures Given the low risk for pancreatic fistula no externalized trans-anastomotic stent will be placed End-to-side hepaticojejunostomy will be performed 20 cm distally to PJ with absorbable continuous or interrupted sutures and end-to side duodenojejunostomy with absorbable interrupted sutures Two perianastomotic open passive penrose Easyflow drains are placed at the end of the procedure close to biliary anastomosis and close to PJ anastomosis15
In conclusion we aim through this randomized trial to demonstrate that POD1 drains removal after PD is not inferior to POD3 removal in low and medium risk patients and moreover it could prevent delayed removal-related complications helping to guide post-operative care and improve patient outcomes
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