Clinical trial NCT03699917: Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy
Official title: The Impact of Intraoperative Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticoduodenectomy
Stroke Volume Variation
Keywords: Fluid therapy
gastric emptying
pancreatic leak
pancreaticoduodenectomy
stroke volume variation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative complications (Pancreatic leak and delayed gastric emptying)
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: dionisios.vrochides@atriumhealth.org
name: Dionisios Vrochides, MD
role: PRINCIPAL_INVESTIGATOR
References: