Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322680
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-08
Brief Title:
Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
The Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy A Multi-center Prospective Randomized Controlled Phase Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Pancreaticoduodenectomy PD is the standard treatment for tumors of the pancreatic head distal bile duct duodenum and ampulla of Vater With advances in surgical experience and instrumentation the mortality rate of PD has decreased to below 5 in high-volume pancreatic centers However the postoperative complication rate remains high at 25-50 limiting the development and application of PD
The main postoperative complications of PD are postoperative pancreatic fistula POPF delayed gastric emptying DGE post-pancreatectomy hemorrhage PPH and biliary leakage BL POPF BL and the subsequent abdominal infection PPH etc are the main causes of death during hospitalization Even in large relatively mature pancreatic centers the incidence of POPF remains as high as 10-40 In recent years various methods have been used to prevent and treat POPF and BL after PD such as pancreatic duct stent external drainage and external biliary drainage
To date there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence mortality rate etc but the research results are not consistent Overall pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD Currently there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula For example a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula However due to the low level of evidence only a few risk factors such as pancreatic texture and pancreatic duct diameter were included and the risk of POPF was not systematically evaluated Further clinical exploration and verification are needed In 2013 Mark P Callery et al proposed a pancreatic fistula risk score The fistula risk score FRS based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group which included pancreatic texture pathological type pancreatic duct diameter and intraoperative blood loss This model can be used to systematically and quantitatively evaluate the risk of POPF Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage which may have included too many patients with a low risk of pancreatic fistula resulting in inaccurate results Therefore it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type At the same time pancreatic juice contains a variety of digestive enzymes of which pancreatic lipase trypsin and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein Theoretically biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients
Thus the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication especially POPF
The main postoperative complications of PD are postoperative pancreatic fistula POPF delayed gastric emptying DGE post-pancreatectomy hemorrhage PPH and biliary leakage BL POPF BL and the subsequent abdominal infection PPH etc are the main causes of death during hospitalization Even in large relatively mature pancreatic centers the incidence of POPF remains as high as 10-40 In recent years various methods have been used to prevent and treat POPF and BL after PD such as pancreatic duct stent external drainage and external biliary drainage
To date there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence mortality rate etc but the research results are not consistent Overall pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD Currently there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula For example a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula However due to the low level of evidence only a few risk factors such as pancreatic texture and pancreatic duct diameter were included and the risk of POPF was not systematically evaluated Further clinical exploration and verification are needed In 2013 Mark P Callery et al proposed a pancreatic fistula risk score The fistula risk score FRS based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group which included pancreatic texture pathological type pancreatic duct diameter and intraoperative blood loss This model can be used to systematically and quantitatively evaluate the risk of POPF Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage which may have included too many patients with a low risk of pancreatic fistula resulting in inaccurate results Therefore it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type At the same time pancreatic juice contains a variety of digestive enzymes of which pancreatic lipase trypsin and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein Theoretically biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients
Thus the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication especially POPF
Detailed Description:
Pancreaticoduodenectomy PD is the standard treatment for tumors of the pancreatic head distal bile duct duodenum and ampulla of Vater With advances in surgical experience and instrumentation the mortality rate of PD has decreased to below 5 in high-volume pancreatic centers However the postoperative complication rate remains high at 25-50 limiting the development and application of PD
The main postoperative complications of PD are postoperative pancreatic fistula POPF delayed gastric emptying DGE post-pancreatectomy hemorrhage PPH and biliary leakage BL POPF BL and the subsequent abdominal infection PPH etc are the main causes of death during hospitalization Even in large relatively mature pancreatic centers the incidence of POPF remains as high as 10-40 In recent years various methods have been used to prevent and treat POPF and BL after PD such as pancreatic duct stent external drainage and external biliary drainage
To date there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence mortality rate etc but the research results are not consistent Overall pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD Currently there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula For example a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula However due to the low level of evidence only a few risk factors such as pancreatic texture and pancreatic duct diameter were included and the risk of POPF was not systematically evaluated Further clinical exploration and verification are needed In 2013 Mark P Callery et al proposed a pancreatic fistula risk score The fistula risk score FRS based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group which included pancreatic texture pathological type pancreatic duct diameter and intraoperative blood loss This model can be used to systematically and quantitatively evaluate the risk of POPF Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage which may have included too many patients with a low risk of pancreatic fistula resulting in inaccurate results Therefore it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type At the same time pancreatic juice contains a variety of digestive enzymes of which pancreatic lipase trypsin and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein Theoretically biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients
Thus the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication especially POPF
The main postoperative complications of PD are postoperative pancreatic fistula POPF delayed gastric emptying DGE post-pancreatectomy hemorrhage PPH and biliary leakage BL POPF BL and the subsequent abdominal infection PPH etc are the main causes of death during hospitalization Even in large relatively mature pancreatic centers the incidence of POPF remains as high as 10-40 In recent years various methods have been used to prevent and treat POPF and BL after PD such as pancreatic duct stent external drainage and external biliary drainage
To date there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence mortality rate etc but the research results are not consistent Overall pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD Currently there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula For example a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula However due to the low level of evidence only a few risk factors such as pancreatic texture and pancreatic duct diameter were included and the risk of POPF was not systematically evaluated Further clinical exploration and verification are needed In 2013 Mark P Callery et al proposed a pancreatic fistula risk score The fistula risk score FRS based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group which included pancreatic texture pathological type pancreatic duct diameter and intraoperative blood loss This model can be used to systematically and quantitatively evaluate the risk of POPF Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage which may have included too many patients with a low risk of pancreatic fistula resulting in inaccurate results Therefore it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type At the same time pancreatic juice contains a variety of digestive enzymes of which pancreatic lipase trypsin and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein Theoretically biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients
Thus the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication especially POPF
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