Standard vs. radical pancreaticoduodenectomy for periampullary adenocarcinoma: a prospective, randomized trial evaluating quality of life in pancreaticoduodenectomy survivors.

This study was designed to assess the health-related quality of life (QOL) of patients who had been randomly assigned to either standard or radical pancreaticoduodenectomy for periampullary adenocarcinoma. Pancreaticoduodenectomy has been performed in increasing numbers for periampullary adenocarcinoma. The appropriate extent of resection (standard vs. radical [extended]) remains controversial, particularly as concerns survival benefit. Past reports comparing standard vs. radical resection have suggested that the more extensive resection is attended by negative functional outcomes (diarrhea and weight loss) and poorer QOL, diminishing the impact of any possible survival advantage of the radical resection. A prospective, randomized single-institution trial comparing standard pancreaticoduodenectomy (pylorus preservation preferred) to radical pancreaticoduodenectomy (including distal gastrectomy and retroperitoneal lymphadenectomy) evaluated 299 patients with periampullary adenocarcinoma between April 1996 and June 2001. A standard Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) QOL survey designed for hepatobiliary cancer was sent to 150 of these patients surviving pancreaticoduodenectomy. QOL and functional status were assessed via a series of subscale scores for physical, social, emotional, and functional well-being. A total of 105 QOL surveys (70%) were returned and analyzed, with 55 of the patients having been randomized to the standard group and 50 to the radical group. The patients were evaluated at a mean of 2.2 years after pancreaticoduodenectomy. The two groups were statistically similar with regard to multiple parameters including age at operation (64.6 years), race, intraoperative blood transfusions, pathologic diagnosis and staging, and perioperative complications. The radical group had a significantly higher percentage of men (66% vs. 44%; P = 0.02), a longer operative time (369 minutes vs. 327 minutes; P < 0.001), and a longer postoperative length of hospital stay (13.6 days vs. 10.1 days; P < 0.01). The FACT-Hep total QOL scores were similar between the standard and radical groups: 143.5 vs. 147.3, respectively. Additionally, the individual FACT-G subscale scores evaluating physical (22.1 vs. 23.3), social (24.5 vs. 24.4), emotional (19.2 vs. 19.6), and functional well-being (20.6 vs. 22.4) were comparable between the standard and radical groups. Subgroup analyses based on pathologic diagnosis (pancreatic, ampullary, distal bile duct, etc.) failed to reveal any differences in QOL assessment between the standard and radical pancreaticoduodenectomy groups. Finally, QOL measures were similar when comparing time since operation (<2 years' follow-up vs. >2 years' follow-up) and age (< or =65 years vs. >65 years). This is the largest report comparing QOL assessment in survivors of pancreaticoduodenectomy randomized between standard and radical resection. These data demonstrate no differences in long-term QOL between standard and radical resection. These results imply that no negative long-term QOL measures are associated with radical pancreaticoduodenectomy (as performed in this study) for periampullary adenocarcinoma. Copyright 2003 The Society for Surgery of the Alimentary Tract, Inc.

RCT Entities:   Population Interventions Outcomes