Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreaticoduodenectomy Stroke Volume Variation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with SVV < 12

Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of less than 12.

No interventions assigned to this group

Patients with SVV > or = 12

Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of greater than or equal to 12.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No