The Characterization and Prediction of ISGPF Grade C Fistulas Following Pancreatoduodenectomy

Matthew T. McMillan, Charles M. Vollmer, Horacio J. Asbun, Chad G. Ball, Claudio Bassi, Joal D. Beane, Adam C. Berger, Mark Bloomston, Mark P. Callery, John D. Christein, Elijah Dixon, Jeffrey A. Drebin, Carlos Fernandez Del Castillo, William E. Fisher, Zhi Ven Fong, Ericka Haverick, Michael House, Steven J. Hughes, Tara S. Kent, John W. KunstmanGiuseppe Malleo, Amy L. McElhany, Ronald R. Salem, Kevin Soares, Michael H. Sprys, Vicente Valero, Ammara A. Watkins, Christopher L. Wolfgang, Stephen W. Behrman

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

Introduction: International Study Group of Pancreatic Fistula (ISGPF) grade C postoperative pancreatic fistulas (POPF) are the greatest contributor to major morbidity and mortality following pancreatoduodenectomy (PD); however, their infrequent occurrence has hindered deeper analysis. This study sought to develop a predictive algorithm, which could facilitate effective management of this challenging complication. Methods: Data were accrued from 4301 PDs worldwide. Demographics, postoperative management, and microbiological characteristics of grade C POPFs were evaluated. American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) preoperative and intraoperative variables were compared between grade C POPFs and a 639-case sample of non-grade C POPFs. Risk factors for grade C POPF formation were identified using regression analysis. Results: Grade C POPFs developed in 79 patients (1.8 %). Deaths (90 days) occurred in 2.0 % (N = 88) of the overall series, with 35 % (N = 25) occurring in the presence of a grade C POPF. Reoperations occurred 72.2 % of the time. The rates of single- and multi-system organ failure were 28.2 and 39.7 %, respectively. Mortality rates escalated with pulmonary, renal, and neurologic organ failure, but they were unaffected by reoperation(s). The median number of complications incurred was four (IQR: 2–5), and the median duration of hospital stay was 32 (IQR: 21–54) days. Warning signs for impending grade C POPFs most often presented on postoperative day (POD) 6. Adjuvant chemotherapy might have benefited 55.7 % of grade C POPF patients, yet it was delayed in 25.6 % and never delivered in 67.4 % of these patients. Predictive models for grade C POPF occurrence based on preoperative factors alone and preoperative and intraoperative factors yielded areas under the receiver operating characteristic curve of 0.73 and 0.84 (both P <0.000001), respectively. Conclusion: This global study represents the largest analysis of grade C POPFs following PD. It describes the severe burden that grade C POPFs incur on patients, with high rates of reoperation and infection, while also potentially worsening overall survival by causing death and delay/omission of adjuvant therapy. Additionally, aggressive clinical management for these POPFs did not improve or worsen 90-day mortality. Predictive tools developed through these data may provide value in managing this difficult complication.

Original languageEnglish (US)
Pages (from-to)262-276
Number of pages15
JournalJournal of Gastrointestinal Surgery
Volume20
Issue number2
DOIs
StatePublished - Feb 1 2016

Fingerprint

Pancreatic Fistula
Pancreaticoduodenectomy
Fistula
Reoperation
Mortality
Adjuvant Chemotherapy
Quality Improvement
ROC Curve
Nervous System
Length of Stay
Regression Analysis
Demography
Morbidity
Kidney
Lung
Survival
Infection

Keywords

  • ISGPF grade C
  • Pancreatic fistula
  • Risk assessment

ASJC Scopus subject areas

  • Surgery
  • Gastroenterology

Cite this

McMillan, M. T., Vollmer, C. M., Asbun, H. J., Ball, C. G., Bassi, C., Beane, J. D., ... Behrman, S. W. (2016). The Characterization and Prediction of ISGPF Grade C Fistulas Following Pancreatoduodenectomy. Journal of Gastrointestinal Surgery, 20(2), 262-276. https://doi.org/10.1007/s11605-015-2884-2

The Characterization and Prediction of ISGPF Grade C Fistulas Following Pancreatoduodenectomy. / McMillan, Matthew T.; Vollmer, Charles M.; Asbun, Horacio J.; Ball, Chad G.; Bassi, Claudio; Beane, Joal D.; Berger, Adam C.; Bloomston, Mark; Callery, Mark P.; Christein, John D.; Dixon, Elijah; Drebin, Jeffrey A.; Castillo, Carlos Fernandez Del; Fisher, William E.; Fong, Zhi Ven; Haverick, Ericka; House, Michael; Hughes, Steven J.; Kent, Tara S.; Kunstman, John W.; Malleo, Giuseppe; McElhany, Amy L.; Salem, Ronald R.; Soares, Kevin; Sprys, Michael H.; Valero, Vicente; Watkins, Ammara A.; Wolfgang, Christopher L.; Behrman, Stephen W.

In: Journal of Gastrointestinal Surgery, Vol. 20, No. 2, 01.02.2016, p. 262-276.

Research output: Contribution to journalArticle

McMillan, MT, Vollmer, CM, Asbun, HJ, Ball, CG, Bassi, C, Beane, JD, Berger, AC, Bloomston, M, Callery, MP, Christein, JD, Dixon, E, Drebin, JA, Castillo, CFD, Fisher, WE, Fong, ZV, Haverick, E, House, M, Hughes, SJ, Kent, TS, Kunstman, JW, Malleo, G, McElhany, AL, Salem, RR, Soares, K, Sprys, MH, Valero, V, Watkins, AA, Wolfgang, CL & Behrman, SW 2016, 'The Characterization and Prediction of ISGPF Grade C Fistulas Following Pancreatoduodenectomy', Journal of Gastrointestinal Surgery, vol. 20, no. 2, pp. 262-276. https://doi.org/10.1007/s11605-015-2884-2
McMillan, Matthew T. ; Vollmer, Charles M. ; Asbun, Horacio J. ; Ball, Chad G. ; Bassi, Claudio ; Beane, Joal D. ; Berger, Adam C. ; Bloomston, Mark ; Callery, Mark P. ; Christein, John D. ; Dixon, Elijah ; Drebin, Jeffrey A. ; Castillo, Carlos Fernandez Del ; Fisher, William E. ; Fong, Zhi Ven ; Haverick, Ericka ; House, Michael ; Hughes, Steven J. ; Kent, Tara S. ; Kunstman, John W. ; Malleo, Giuseppe ; McElhany, Amy L. ; Salem, Ronald R. ; Soares, Kevin ; Sprys, Michael H. ; Valero, Vicente ; Watkins, Ammara A. ; Wolfgang, Christopher L. ; Behrman, Stephen W. / The Characterization and Prediction of ISGPF Grade C Fistulas Following Pancreatoduodenectomy. In: Journal of Gastrointestinal Surgery. 2016 ; Vol. 20, No. 2. pp. 262-276.
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abstract = "Introduction: International Study Group of Pancreatic Fistula (ISGPF) grade C postoperative pancreatic fistulas (POPF) are the greatest contributor to major morbidity and mortality following pancreatoduodenectomy (PD); however, their infrequent occurrence has hindered deeper analysis. This study sought to develop a predictive algorithm, which could facilitate effective management of this challenging complication. Methods: Data were accrued from 4301 PDs worldwide. Demographics, postoperative management, and microbiological characteristics of grade C POPFs were evaluated. American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) preoperative and intraoperative variables were compared between grade C POPFs and a 639-case sample of non-grade C POPFs. Risk factors for grade C POPF formation were identified using regression analysis. Results: Grade C POPFs developed in 79 patients (1.8 {\%}). Deaths (90 days) occurred in 2.0 {\%} (N = 88) of the overall series, with 35 {\%} (N = 25) occurring in the presence of a grade C POPF. Reoperations occurred 72.2 {\%} of the time. The rates of single- and multi-system organ failure were 28.2 and 39.7 {\%}, respectively. Mortality rates escalated with pulmonary, renal, and neurologic organ failure, but they were unaffected by reoperation(s). The median number of complications incurred was four (IQR: 2–5), and the median duration of hospital stay was 32 (IQR: 21–54) days. Warning signs for impending grade C POPFs most often presented on postoperative day (POD) 6. Adjuvant chemotherapy might have benefited 55.7 {\%} of grade C POPF patients, yet it was delayed in 25.6 {\%} and never delivered in 67.4 {\%} of these patients. Predictive models for grade C POPF occurrence based on preoperative factors alone and preoperative and intraoperative factors yielded areas under the receiver operating characteristic curve of 0.73 and 0.84 (both P <0.000001), respectively. Conclusion: This global study represents the largest analysis of grade C POPFs following PD. It describes the severe burden that grade C POPFs incur on patients, with high rates of reoperation and infection, while also potentially worsening overall survival by causing death and delay/omission of adjuvant therapy. Additionally, aggressive clinical management for these POPFs did not improve or worsen 90-day mortality. Predictive tools developed through these data may provide value in managing this difficult complication.",
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T1 - The Characterization and Prediction of ISGPF Grade C Fistulas Following Pancreatoduodenectomy

AU - McMillan, Matthew T.

AU - Vollmer, Charles M.

AU - Asbun, Horacio J.

AU - Ball, Chad G.

AU - Bassi, Claudio

AU - Beane, Joal D.

AU - Berger, Adam C.

AU - Bloomston, Mark

AU - Callery, Mark P.

AU - Christein, John D.

AU - Dixon, Elijah

AU - Drebin, Jeffrey A.

AU - Castillo, Carlos Fernandez Del

AU - Fisher, William E.

AU - Fong, Zhi Ven

AU - Haverick, Ericka

AU - House, Michael

AU - Hughes, Steven J.

AU - Kent, Tara S.

AU - Kunstman, John W.

AU - Malleo, Giuseppe

AU - McElhany, Amy L.

AU - Salem, Ronald R.

AU - Soares, Kevin

AU - Sprys, Michael H.

AU - Valero, Vicente

AU - Watkins, Ammara A.

AU - Wolfgang, Christopher L.

AU - Behrman, Stephen W.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Introduction: International Study Group of Pancreatic Fistula (ISGPF) grade C postoperative pancreatic fistulas (POPF) are the greatest contributor to major morbidity and mortality following pancreatoduodenectomy (PD); however, their infrequent occurrence has hindered deeper analysis. This study sought to develop a predictive algorithm, which could facilitate effective management of this challenging complication. Methods: Data were accrued from 4301 PDs worldwide. Demographics, postoperative management, and microbiological characteristics of grade C POPFs were evaluated. American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) preoperative and intraoperative variables were compared between grade C POPFs and a 639-case sample of non-grade C POPFs. Risk factors for grade C POPF formation were identified using regression analysis. Results: Grade C POPFs developed in 79 patients (1.8 %). Deaths (90 days) occurred in 2.0 % (N = 88) of the overall series, with 35 % (N = 25) occurring in the presence of a grade C POPF. Reoperations occurred 72.2 % of the time. The rates of single- and multi-system organ failure were 28.2 and 39.7 %, respectively. Mortality rates escalated with pulmonary, renal, and neurologic organ failure, but they were unaffected by reoperation(s). The median number of complications incurred was four (IQR: 2–5), and the median duration of hospital stay was 32 (IQR: 21–54) days. Warning signs for impending grade C POPFs most often presented on postoperative day (POD) 6. Adjuvant chemotherapy might have benefited 55.7 % of grade C POPF patients, yet it was delayed in 25.6 % and never delivered in 67.4 % of these patients. Predictive models for grade C POPF occurrence based on preoperative factors alone and preoperative and intraoperative factors yielded areas under the receiver operating characteristic curve of 0.73 and 0.84 (both P <0.000001), respectively. Conclusion: This global study represents the largest analysis of grade C POPFs following PD. It describes the severe burden that grade C POPFs incur on patients, with high rates of reoperation and infection, while also potentially worsening overall survival by causing death and delay/omission of adjuvant therapy. Additionally, aggressive clinical management for these POPFs did not improve or worsen 90-day mortality. Predictive tools developed through these data may provide value in managing this difficult complication.

AB - Introduction: International Study Group of Pancreatic Fistula (ISGPF) grade C postoperative pancreatic fistulas (POPF) are the greatest contributor to major morbidity and mortality following pancreatoduodenectomy (PD); however, their infrequent occurrence has hindered deeper analysis. This study sought to develop a predictive algorithm, which could facilitate effective management of this challenging complication. Methods: Data were accrued from 4301 PDs worldwide. Demographics, postoperative management, and microbiological characteristics of grade C POPFs were evaluated. American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) preoperative and intraoperative variables were compared between grade C POPFs and a 639-case sample of non-grade C POPFs. Risk factors for grade C POPF formation were identified using regression analysis. Results: Grade C POPFs developed in 79 patients (1.8 %). Deaths (90 days) occurred in 2.0 % (N = 88) of the overall series, with 35 % (N = 25) occurring in the presence of a grade C POPF. Reoperations occurred 72.2 % of the time. The rates of single- and multi-system organ failure were 28.2 and 39.7 %, respectively. Mortality rates escalated with pulmonary, renal, and neurologic organ failure, but they were unaffected by reoperation(s). The median number of complications incurred was four (IQR: 2–5), and the median duration of hospital stay was 32 (IQR: 21–54) days. Warning signs for impending grade C POPFs most often presented on postoperative day (POD) 6. Adjuvant chemotherapy might have benefited 55.7 % of grade C POPF patients, yet it was delayed in 25.6 % and never delivered in 67.4 % of these patients. Predictive models for grade C POPF occurrence based on preoperative factors alone and preoperative and intraoperative factors yielded areas under the receiver operating characteristic curve of 0.73 and 0.84 (both P <0.000001), respectively. Conclusion: This global study represents the largest analysis of grade C POPFs following PD. It describes the severe burden that grade C POPFs incur on patients, with high rates of reoperation and infection, while also potentially worsening overall survival by causing death and delay/omission of adjuvant therapy. Additionally, aggressive clinical management for these POPFs did not improve or worsen 90-day mortality. Predictive tools developed through these data may provide value in managing this difficult complication.

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KW - Pancreatic fistula

KW - Risk assessment

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