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The Value of Drains as a Fistula Mitigation Strategy for Pancreatoduodenectomy: Something for Everyone? Results of a Randomized Prospective Multi-institutional Study

  • 2014 SSAT Plenary Presentation
  • Published:
Journal of Gastrointestinal Surgery Aims and scope

Abstract

Background

A recent randomized, controlled trial investigating intraperitoneal drain use during pancreatoduodenectomy (PD) had a primary goal of assessing overall morbidity. It was terminated early with findings that routine elimination of drains in PD increases mortality and the severity and frequency of overall complications. Here, we provide a follow-up analysis of drain value in reference to clinically relevant postoperative pancreatic fistula (CR-POPF).

Methods

Nine institutions performed 137 PDs, with patients randomized to intraperitoneal drainage (N = 68) or no drainage (N = 69). The Fistula Risk Score (FRS), a 10-point scale derived from four validated risk factors for CR-POPF, facilitated risk adjustment between treatment groups.

Results

There was no difference in fistula risk between the two cohorts. Overall, CR-POPF rates were higher in the no drain group compared to the drain group (20.3 vs. 13.2 %; p = 0.269). Patients with negligible/low FRS risk had higher rates of CR-POPF when drains were used (14.8 vs. 4.0 %; p = 0.352). Conversely, there were significantly fewer CR-POPFs (12.2 vs. 29.5 %; p = 0.050) when drains were used with moderate/high risk patients. Lastly, moderate/high risk patients who suffered a CR-POPF had reduced 90-day mortality (22.2 vs. 42.9 %) when a drain was used.

Conclusion

The results of this analysis suggest that drains diminish the rate and severity of CR-POPF in patients with moderate/high risk, but they could possibly be avoided in the roughly one third of patients with negligible/low risk.

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Acknowledgments

The authors thank Ericka Haverick, BSN, RN; Amber Delvisco, CCRP, CCRC; Gina Mateia, BA; Cynthia Allbritton, RN; Ben Maccaby, Jenna Gates, PA; Jerry Owens, CCRP; and Kenia Ramos, RN, who served as coordinators for the study and performed quality assurance functions and regulatory compliance. The authors also thank Jason Fleming; MD; Susan Hilsenbeck, PhD; F. Charles Brunicardi, MD; Kenneth Mattox, MD; Deborah McAbee, JD; Sarah McNees, PhD, CCRP; and Crystal Ross, who served on the Data Safety Monitoring Committee. Finally, we appreciate the contributions of the following surgeons to accrual of patients in the trial: Taylor Riall, MD, Peter Muscarella, MD, Jose Trevino, MD, Attila Nakeeb, MD, C. Max Schmidt, MD, Kevin Behrns, MD, E. Christopher Ellison, MD, Kyle Perry, MD, Jeffrey Drebin, MD, Michael House, MD, Sherif Abdel-Misih, MD, Eric J. Silberfein, MD, Steven Goldin, MD, Somala Mohammed, MD.

Author information

Authors and Affiliations

  1. Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA

    Matthew T. McMillan & Charles Vollmer

  2. The Elkins Pancreas Center, Michael E. DeBakey Department of Surgery, and Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA

    William E. Fisher, George Van Buren II & Amy McElhany

  3. Department of Surgery, The Ohio State University, Columbus, OH, USA

    Mark Bloomston

  4. Department of Surgery, University of Florida, Gainesville, FL, USA

    Steven J. Hughes

  5. Department of Surgery, Jefferson Medical College, Philadelphia, PA, USA

    Jordan Winter

  6. Department of Surgery, Baptist Memorial Hospital/University of Tennessee Health Science Center, Memphis, TN, USA

    Stephen W. Behrman

  7. Department of Surgery, Indiana University, Indianapolis, IN, USA

    Nicholas J. Zyromski

  8. Department of Surgery, University of South Florida, Tampa, FL, USA

    Vic Velanovich

  9. Department of Surgery, The University of Texas Medical Branch, Galveston, TX, USA

    Kimberly Brown

  10. Medical University of South Carolina, Charleston, SC, USA

    Katherine A. Morgan

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  1. Matthew T. McMillan
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Correspondence to Charles Vollmer.

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Discussant

Dr. Michael W Mulholland (Ann Arbor, MI): Nine high-volume academic institutions, 15 pancreatic surgeons, and their 137 patients contributed to this series. The study has much to recommend it. Positives include an important question, the variety of institutions in which the work was performed, the large number of highly qualified surgeons participating, and the real-world environment in which the study was performed. The results are robust and generalizable. Like any real-world study, however, the current report has limitations. A variety of operative techniques were employed. More than one type of drain system was used. Because of the early closure larger study from which the current investigation is derived, a relatively small number of patients were included. The results clearly advance the field of pancreatic surgery.

The treatment groups were well matched. The overall rate of pancreatic postoperative fistula was about 25 % and about two thirds of these fistulas were clinically important. There are two major, but somewhat discordant, results. First, in low risk patients, the use of drains correlated with a higher rate of clinically relevant postoperative fistulas, and drains were not advantageous in this setting of low risk factors. In contrast, patients with moderate or high risk had significantly fewer clinically relevant fistula events when drains were utilized. Further, when drains were employed and fistulas did occur, the outcomes were less adverse. These observations could lead to the general conclusion that drains should be avoided in low risk patients, but would be mandatory in higher risk situations.

This study is important but raises the following questions:

1. Since the rate of clinically relevant postoperative fistula was lower in the high risk group when drains were employed, an interpretation could be that the use of drains prevents fistulas from occurring. It has been assumed by most that the use of drainage systems simply mitigates the effects of leakage when that occurs. Do you believe that the use of drains actually prevents the occurrence of fistulas?

2. In patients with low risk factors, all of which will be known by the surgeon at the end of the operation. Do you now advocate that drains be omitted?

3. Why was so much latitude permitted in the type of drainage used by the pancreatic surgeons that participated in this study? It seems possible that the rate of fistula formation would be different with a closed suction drainage system relative to one in which suction is not applied. Can you explain this aspect of your study design?

Closing Discussant

Dr. McMillan:

Thank you, Dr. Mulholland.

1. The existing literature, including some of our own work, suggests that the drivers of fistula are endogenous and intraoperative factors. It is hard to imagine how routine drain placement can “counteract” such factors to actually prevent the physical processes that contribute to an anastomotic leak; however, it is our belief that drains are beneficial in dampening the severity of fistulas, when they have developed, by allowing for earlier detection, evacuation of degradative fluids and infection, and otherwise cautious management.

2. As you mentioned, when drains were used among patients with negligible (FRS 0) and low (FRS 1–2) fistula risk, clinically relevant fistula actually occurred more frequently; however, the difference in rates was not statistically significant, so we cannot definitively suggest a change in practice for surgeons operating on patients with these risk profiles. In the absence of definitive proof, we feel that it is important to not be dogmatic about this. In other words, we believe that the clinical judgment for each individual patient should take precedence when deciding upon drain placement for patients, despite exhibiting negligible and low inherent fistula risk. Each surgeon will have their own comfort level in regards to the scenarios of patient risk in which they are comfortable not placing drains.

3. Truthfully, there was no particular consideration given to this question when the study was initially designed. Obviously, you are getting at the notion that some believe the physical characteristics of certain drainage processes can be harmful. As it turns out, the point was moot as, in this series, all drains were of the closed suction variety.

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McMillan, M.T., Fisher, W.E., Van Buren, G. et al. The Value of Drains as a Fistula Mitigation Strategy for Pancreatoduodenectomy: Something for Everyone? Results of a Randomized Prospective Multi-institutional Study. J Gastrointest Surg 19, 21–31 (2015). https://doi.org/10.1007/s11605-014-2640-z

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