Craig P. Fischer, M.D. (Houston, TX): I would like to congratulate you and your co-authors for carrying out a large multi‑institutional study which seeks to determine if drain data are predictive of leak following pancreaticoduodenectomy. This study also intends to validate the International Study Group on Pancreatic Fistula(ISGPF)criteria for pancreatic fistula. Participating surgeons in this Web‑based program, entered de‑identified data into the database relevant to the Whipple operation. The two definitions that were looked at were the ISGPF definition versus the Sarr definition (described in the manuscript). The definitions have different thresholds for amylase content and drain output. One of the issues here is the wide range of reported pancreatic fistula following the Whipple operation – this has led to various proposals to standardize the reporting of this complication. Most prominently, the International Study Group on Pancreatic Fistula met and proposed a system of classification.
In this study there were more grade A and B leaks that were detected by the international study group definition, than by the Sarr definition. Both definitions, however, determined grade C leaks equally. The ISGPF definition was able to capture more patients with clinically relevant leaks than Sarr's classification, however, both definitions missed some cases of clinically significant leaks (grade B and C).
I have two specific questions for you. The first, in the manuscript you modified the international study group's definition. The original definition, placed percutaneous drainage placed into class C, yet you moved it to class B. This does seem to be some disagreement about the validity of the international study group's definition, and I would like your comment about other definitions. We do need to settle on a single definition, validate it, and then report our data according to the same definition. Does your group plan to use the ISGPF definition, a modification, or a different definition as the project moves forward? There is a recent publication in Surgery in January by Steve Strasberg and Pierre Clavien, which is the most recent contribution to this effort. I would appreciate your comments.
Of course, the real power of this database is to compare techniques, and clinical risk factors that contribute to the development of pancreatic fistula. This database will eventually have over 5,000 patients for examination. So what future data points will you be examining? Will you examine the correlation between various techniques of the pancreatic/enteric anastomosis and fistula as well as patient‑ and pancreas‑specific risk factors.
Again, I would like to thank the authors for providing me the manuscript in advance and to congratulate you all on an outstanding effort that is a real advance in moving towards a unified definition, used by all authors in this field, so we may accurately compare our work. Thanks very much.
Michael B. Farnell, M.D. (Rochester MN): Dr. Fischer, thank you very much for your comments and your questions. I would like to emphasize that while this is a beginning, it does demonstrate the feasibility of a group to utilize both technology and collaboration to attempt to improve outcome.
Drain data are a harbinger of complications but alone are insufficient to define a pancreatic leak. Perhaps the drain data would be best at directing drain management. Clinical information is essential in the definition of a pancreatic leak.
You asked about recently published grading systems for complications following pancreaticoduodenectomy. I would agree with Dr. Strasberg, and I am sorry that he can't be here to participate in that discussion. A grading system based upon the need for an intervention for a leak is perhaps more relevant than a grading system based upon biochemical analysis of drain fluid and outcome. So the answer to your question is yes, I think there should be refinements in the ISGPF grading system for pancreatic fistula.
Your second question addressed what the future holds. As we refine the web-based tool, I would like to see a quality committee constituted to help ensure the quality and accuracy of the data. Data entry personnel need to be trained to ensure data accuracy and consistent definitions. Once accomplished, we can begin to examine issues such as stent versus no stent, technique of anastomosis, use of loupe magnification, use of an operating microscope, and the question of whether a drain should even be used at all. There is support in the literature for Whipple resection without placing a drain and responding to a change in clinical course with appropriate intervention.
Members of the Pancreatic Anastomotic Leak Study Group: David Adams, M.D., Charleston, South Carolina; Gerard Aranha, M.D., Chicago, IL; Mark Callery, M.D., Boston, MA; Roberto Coppola, M.D., Rome, Italy; Elijah Dixon, M.D., Calgary, Alberta, Canada; Massimo Falconi, M.D., Verona, Italy; John Hoffman, M.D., Philadelphia, PA; Thomas Howard, M.D., Indianapolis, Indiana; Frank Makowiec, M.D., Freiberg, Germany; Franco Mosca, M.D., Pisa, Italy; Thomas Neufang, M.D., Mannheim, Germany; Marco Niedergethmann, Mannheim, Germany; Paolo Pederzoli, Verona, Italy; Sergio Pedrazzoli, Padua, Italy; Stefan Post, M.D., Mannheim, Germany; Roberto Salvia, M.D., Verona, Italy; Hiroyuki Shinchi, M.D., Kagoshima, Japan; Margo Shoup, M.D., Chicago, IL; Charles Vollmer, M.D., Boston, MA; Frank Willeke, M.D., Mannheim, Germany; Hiroki Yamaue, M.D., Wakayama, Japan.