Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy
The Impact of Intraoperative Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy
1 other identifier
observational
64
1 country
2
Brief Summary
Optimal fluid balance is critical to minimize anastomotic edema in patients undergoing pancreaticoduodenectomy. This study examined the effects of decreased fluid administration on rates of postoperative pancreatic leak and delayed gastric emptying.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2016
CompletedFirst Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedMarch 23, 2023
October 1, 2018
1.6 years
October 3, 2018
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative complications (Pancreatic leak and delayed gastric emptying)
Number of patients with postoperative pancreatic leak and postoperative delayed gastric emptying. Stroke volume is calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume).
30 days postoperatively
Study Arms (2)
Patients with SVV < 12
Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of less than 12.
Patients with SVV > or = 12
Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of greater than or equal to 12.
Eligibility Criteria
Operations were performed at a high-volume center by one of four fellowship-trained hepatopancreatobiliary surgeons using an open approach. All patients underwent an open approach for pancreaticoduodenectomy.
You may qualify if:
- pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign lesion
You may not qualify if:
- venous resection and reconstructive involving the portal venous system
- estimated blood loss exceeding two liters
- high dose steroid administration
- use of irreversible electroporation for margin enhancement
- lack of SVV equipment or inconsistent SVV recordings
- use of the robotic surgical system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Carolinas Medical Center
Charlotte, North Carolina, 28232, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Dionisios Vrochides, MD
dionisios.vrochides@atriumhealth.org
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 9, 2018
Study Start
January 1, 2015
Primary Completion
July 31, 2016
Study Completion
July 31, 2016
Last Updated
March 23, 2023
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share