Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024343
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-23
Brief Title:
Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Repair or Reconstruction
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Long-term Prognosis and Quality of Life in Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Repair or Reconstruction A Multicenter Prospective Single-Arm Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
The aim of this study is to evaluate the impact of concomitant main pancreatic duct repair or reconstruction during minimally invasive pancreatic tumor enucleation on long-term patient prognosis and quality of life
Detailed Description:
Standard surgical procedures for benign or low-grade malignant pancreatic tumors is associated with increased risks of postoperative complications and long-term pancreatic functional impairment while parenchyma-sparing pancreatectomy such as enucleation can reduce the incidence of complications and preserve healthy parenchyma thereby preserve both endocrine and exocrine pancreatic function It has been reported that pancreatic tumor enucleation is a safe and feasible approach in preserving normal physiological function in patients undergoing pancreatic surgery
With the growing emphasis on routine screenings and the application of high-quality thin-slice imaging techniques the detection rates of pancreatic tumors have witnessed a steady increase Additionally there is a notable trend towards younger patients being diagnosed with pancreatic tumors Consequently in conjunction with ensuring safe and thorough tumor resection while maximizing preservation of pancreatic function there is a current clinical demand to further reduce surgical trauma
Literature reviews and meta-analyses have demonstrated that minimally invasive enucleation procedures offer well-known advantages associated with minimally invasive approaches such as shorter postoperative hospital stays and lower overall complication rates While the occurrence rate of severe complications such as postoperative hemorrhage remains relatively low the development of postoperative pancreatic fistula POPF continues to pose a challenging issue
The distance between the tumor and the main pancreatic duct MPD is considered a crucial factor influencing the occurrence of POPF after enucleation However these data have been rarely described in previous studies making it challenging to accurately assess their actual impact on the rate of POPF occurrence Heeger et al suggested that the risk of POPF increases with closer proximity of the tumor to the MPD The incidence of POPF was higher in deep-seated tumors after pancreatic enucleation distance to MPD 3 mm compared to superficial tumors 3 mm 733 vs 300 P0002 Other studies have even limited this critical distance to 2mm Some research has indicated that if the tumor invades or encases the MPD enucleation surgery should be contraindicated and standard resection should be preferred to avoid the risk of POPF postoperatively However a retrospective analysis by Strobel et al on 166 cases of pancreatic tumor enucleation demonstrated that even tumors in close proximity to the MPD can be safely resected although their study did not include cases with tumor encasement of the MPD In 2021 Professor Liu Rong and colleagues introduced the concept of pancreatic duct surgery and outlined four main surgical approaches MPD repair pancreatic end-to-end anastomosis local excision of branch-duct intraductal papillary mucinous neoplasms and MPD replacement However detailed research data in this field are still lacking
The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures involving MPD repair or reconstruction the control of POPF and the long-term prognosis and quality of life of patients after MPD repair or reconstruction remain unclear Therefore this study aims to conduct a prospective multicenter single-arm clinical trial The results of this study will serve as a valuable reference for clinical practice and promote the development and application of minimally invasive pancreatic tumor enucleation procedures
With the growing emphasis on routine screenings and the application of high-quality thin-slice imaging techniques the detection rates of pancreatic tumors have witnessed a steady increase Additionally there is a notable trend towards younger patients being diagnosed with pancreatic tumors Consequently in conjunction with ensuring safe and thorough tumor resection while maximizing preservation of pancreatic function there is a current clinical demand to further reduce surgical trauma
Literature reviews and meta-analyses have demonstrated that minimally invasive enucleation procedures offer well-known advantages associated with minimally invasive approaches such as shorter postoperative hospital stays and lower overall complication rates While the occurrence rate of severe complications such as postoperative hemorrhage remains relatively low the development of postoperative pancreatic fistula POPF continues to pose a challenging issue
The distance between the tumor and the main pancreatic duct MPD is considered a crucial factor influencing the occurrence of POPF after enucleation However these data have been rarely described in previous studies making it challenging to accurately assess their actual impact on the rate of POPF occurrence Heeger et al suggested that the risk of POPF increases with closer proximity of the tumor to the MPD The incidence of POPF was higher in deep-seated tumors after pancreatic enucleation distance to MPD 3 mm compared to superficial tumors 3 mm 733 vs 300 P0002 Other studies have even limited this critical distance to 2mm Some research has indicated that if the tumor invades or encases the MPD enucleation surgery should be contraindicated and standard resection should be preferred to avoid the risk of POPF postoperatively However a retrospective analysis by Strobel et al on 166 cases of pancreatic tumor enucleation demonstrated that even tumors in close proximity to the MPD can be safely resected although their study did not include cases with tumor encasement of the MPD In 2021 Professor Liu Rong and colleagues introduced the concept of pancreatic duct surgery and outlined four main surgical approaches MPD repair pancreatic end-to-end anastomosis local excision of branch-duct intraductal papillary mucinous neoplasms and MPD replacement However detailed research data in this field are still lacking
The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures involving MPD repair or reconstruction the control of POPF and the long-term prognosis and quality of life of patients after MPD repair or reconstruction remain unclear Therefore this study aims to conduct a prospective multicenter single-arm clinical trial The results of this study will serve as a valuable reference for clinical practice and promote the development and application of minimally invasive pancreatic tumor enucleation procedures
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