DISPACT trial: what do we learn from equivalency?

摘要

In The Lancet, Markus Diener and colleagues report on the effectiveness of stapler versus hand-sewn closure after distal pancreatectomy (the DISPACT randomised trial). Is this trial an important contribution to this costly and incompletely understood surgical problem? Although the past two decades have shown substantial improvements for patients undergoing pancreatic resection, including a large decrease in mortality rates, the management of pancreatic fistula remains vexing. At a minimum, development of a fistula results in added burdens forthe patient, as measured by more procedures and increased length of hospital stay. Because many pancreatic resections are for malignancy, a fistula often delays or prevents a patient from receiving potentially beneficial adjuvant therapy. Additionally, fistula is associated with tens of thousands of dollars in increased health-care costs for each patient. Consequently, DISPACT addresses an important clinical issue. Here, we ask whether the outcome was predestined. Is this type of trial worth the expense required and the extraordinary efforts made by the investigators?