Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02671357
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2016-01-22
Brief Title:
Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy
Sponsor:
University Hospital Gasthuisberg
Organization:
University Hospital Gasthuisberg
Study Overview
Official Title:
Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy With Stented Pancreaticogastrostomy and Roux-en-y Gastro-enterostomy
Status:
COMPLETED
Status Verified Date:
2020-03
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:
ERAMIP
Brief Summary:
This prospective observational cohort study aims to improve the postoperative course after minimally invasive pancreaticoduodenectomy MIP with stented pancreaticogastrostomy sPG for pancreatic head or peri-ampullary neoplasms Patients are submitted to an enhanced recovery after surgery ERAS program with early enteral nutrition EEN
Detailed Description:
Pancreaticoduodenectomy PD is the standard of care for patients with malignant or benign disease of the pancreatic head or peri-ampullary region The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula POPF andor delayed gastric emptying DGE In a recent multicentre randomized controlled trial the investigators have shown pancreaticogastrostomy PG without a stent in the pancreatic duct to be associated with 8 POPF rate significantly lower than pancreaticojejunostomy 20 1 Since then PG reconstruction is considered the standard of care in PD which is also underlined in more recent systematic reviews
In patients without POPF after PD the length of hospital stay is determined by the occurrence of DGE which is poorly understood and currently lacks any effective treatment Patients who developed DGE after PD with PG anastomosis n18 20 had a significantly p0014 longer mean sem length of hospital stay LOS of 263 158 days as compared to 224 127 days for patients without DGE n69 These figures are observed in the investigators center as part of the multicentre RCT
Enhanced recovery after surgery ERAS or fast-track FT programs are able to reduce postoperative length of hospital stay LOS Indeed recently ERAS or FT programs have been implemented successfully in PD 2 Patients were discharged 4 days earlier in the ERAS group without a negative effect on the clinical outcome Still many surgeons are reluctant to implement ERAS programs because they fear compromising patient safety
In efforts to improve the outcomes of PD many surgical techniques have been evaluated to restore the pancreatic digestive continuity after PD However the best way to ensure this and whether or not to perform the procedure via standard open or minimally invasive ie 2- or 3-dimensional laparoscopic 3D-LPD or 3-dimensional robotic surgery RPD is still under debate The investigators have passed the learning curve of 50 3D-LPD and hypothesize the implementation of ERAS and EEN in 3D-LPD can improve short-term outcomes
In patients without POPF after PD the length of hospital stay is determined by the occurrence of DGE which is poorly understood and currently lacks any effective treatment Patients who developed DGE after PD with PG anastomosis n18 20 had a significantly p0014 longer mean sem length of hospital stay LOS of 263 158 days as compared to 224 127 days for patients without DGE n69 These figures are observed in the investigators center as part of the multicentre RCT
Enhanced recovery after surgery ERAS or fast-track FT programs are able to reduce postoperative length of hospital stay LOS Indeed recently ERAS or FT programs have been implemented successfully in PD 2 Patients were discharged 4 days earlier in the ERAS group without a negative effect on the clinical outcome Still many surgeons are reluctant to implement ERAS programs because they fear compromising patient safety
In efforts to improve the outcomes of PD many surgical techniques have been evaluated to restore the pancreatic digestive continuity after PD However the best way to ensure this and whether or not to perform the procedure via standard open or minimally invasive ie 2- or 3-dimensional laparoscopic 3D-LPD or 3-dimensional robotic surgery RPD is still under debate The investigators have passed the learning curve of 50 3D-LPD and hypothesize the implementation of ERAS and EEN in 3D-LPD can improve short-term outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None