Abstract
Background
The Fistula Risk Score (FRS), a ten-point scale that relies on weighted influence of four variables, has been shown to effectively predict clinically relevant postoperative pancreatic fistula (CR-POPF) development and its consequences after pancreatoduodenectomy (PD). The proposed FRS demonstrated excellent predictive capacity; however, external validation of this tool would confirm its universal applicability.
Methods
From 2001 to 2012, 594 PDs with pancreatojejunostomy reconstructions were performed at three institutions. POPFs were graded by International Study Group on Pancreatic Fistula standards as grades A, B, or C. The FRS was calculated for each patient, and clinical outcomes were evaluated across four discrete risk zones as described in the original work. Receiver operator curve analysis was performed to judge model validity.
Results
One hundred forty-two patients developed any sort of POPF, of which 68 were CR-POPF (11.4 % overall; 8.9 % grade B, 2.5 % grade C). Increasing FRS scores (0–10) correlated well with CR-POPF development (p < 0.001) with a C-statistic of 0.716. When segregated by discrete FRS-risk groups, CR-POPFs occurred in low-, moderate-, and high-risk patients, 6.6, 12.9, and 28.6 % of the time, respectively (p < 0.001). Clinical outcomes including complications, length of stay, and readmission rates also increased across risk groups.
Conclusion
This multi-institutional experience confirms the Fistula Risk Score as a valid tool for predicting the development of CR-POPF after PD. Patients devoid of any risk factors did not develop a CR-POPF, and the rate of CR-POPF approximately doubles with each subsequent risk zone. The FRS is validated as a strongly predictive tool, with widespread applicability, which can be readily incorporated into common clinical practice and research analysis.
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Dr. David Mahvi (Chicago, IL): First, I want to congratulate Dr. Miller on a great presentation and a very nice study. As Dr. Mathews noted Sunday in his presidential address, many seemingly important studies are never validated. This study validates the previous work from the pancreatic group at BI Deaconess.
To put this in context: the standardization of nomenclature relative to this complication by Mike Saar and Bill Traverso has allowed everyone to speak the same language. Leaks rarely lead to mortality but clearly impact quality of life in the perioperative period. The impact of leak has been extensively studied and presented at DDW by the group at BI Deaconness.
I have two questions:
1. So what? Why is this information helpful? Are you prepared to NOT resect patients with a high risk of a leak. Assuming you are going to proceed with resection: How do you use this data in preoperative decision making?
2. Was there variability between surgeons?
3. It seemed like the site with the softest glands had the lowest fistula rate. How do you explain this discrepancy?
I very much enjoyed your presentation.
Closing Discussant
Dr. Benjamin Miller:
1. The FRS is not meant as a means of disqualifying a patient from resection. Although some of these variables (i.e., duct size and pathology) can be identified in a preoperative setting, they are almost accurately determined intraoperatively. As such, the FRS is really meant as a tool that surgeons can use intra- and postoperatively to mitigate fistula risk in whatever fashion they deem appropriate. This approach may include modifications of drain use and duration, anastomosis type chosen, stent employment, or the use of octreotide to name a few. Such decisions may be based on the surgeon's interpretation of evidence from the literature or rather their own experience with risky scenarios.
2. We did see some variability between surgeons in this study, but three surgeons (the sample size from one was too small to be analyzed) are not large enough sample to make conclusions about the meaning of this variability. For this reason, a multi-institutional study dedicated to variability of the FRS and actual fistula occurrence has been initiated on a much larger scale.
3. This discrepancy could be due to a number of different factors. Potentially, the surgeon could already be performing optimal management techniques to diminish fistula risk, or the resection could be performed with a technique that compensates for this soft gland. Additionally, although the gland was soft, this result further shows that the other factors that contribute to the FRS add significantly to later fistula development. That is to say, although the gland risk was high, other factors may have been lower to balance the risk. The importance of this work is to demonstrate that there is more to the risk equation than the presence of a single risk factor in isolation.
The original article was submitted after oral presentation at the SSAT 5/20/2013 and The Pancreas Club 5/18/13
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Miller, B.C., Christein, J.D., Behrman, S.W. et al. A Multi-Institutional External Validation of the Fistula Risk Score for Pancreatoduodenectomy. J Gastrointest Surg 18, 172–180 (2014). https://doi.org/10.1007/s11605-013-2337-8
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DOI: https://doi.org/10.1007/s11605-013-2337-8