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Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy

The Impact of Intraoperative Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03699917
Enrollment
64
Registered
2018-10-09
Start date
2015-01-01
Completion date
2016-07-31
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticoduodenectomy, Stroke Volume Variation

Keywords

Fluid therapy, gastric emptying, pancreatic leak, pancreaticoduodenectomy, stroke volume variation

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.

Detailed description

Retrospective study of 10564 patients undergoing pancreaticoduodenectomy at a single institution from January, 2015 through July, 2016. Stroke volume variation (SVV) was tracked and titrated during the procedure. All patients were seen preoperatively in the department clinic setting, and indications for pancreaticoduodenectomy were for pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign. benign and malignant disease. Patients were excluded if they had any of the following during surgery: 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. Primary outcomes measures were recorded for each patient were: pancreatic leak and delayed gastric emptying. Pancreatic leak was defined according to the international study group for pancreatic fistulas: an external fistula with a drain output of any measurable volume after postoperative day three with an amylase level greater than three times the upper limit of the normal serum value. Delayed gastric emptying was defined clinically as persistent postoperative emesis requiring nasogastric tube placement, prokinetic agents, or hospital readmission for endoscopic gastrostomy placement. A comparative analysis of postoperative complications was performed between patients with a median SVV \< 12 during the extirpative and reconstructive phases of the procedure compared with patients with an SVV \> 12. The investigators chose an SVV value of greater than 12 to represent a dry state because previous studies have shown that this value represents decreased fluid administration.

Interventions

None listed

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign lesion

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complications (Pancreatic leak and delayed gastric emptying)30 days postoperativelyNumber 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026