Prospective randomized comparison between pylorus-preserving and standard pancreaticoduodenectomy. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors. [Gastrointestinal quality of life after duodenopancreatectomy in pancreatic carcinoma. Preliminary results of a prospective randomized study: pancreatoduodenectomy or pylorus-preserving pancreatoduodenectomy]. Randomized clinical trial of pylorus-preserving duodenopancreatectomy versus classical Whipple resection-long term results.
Pancreaticoduodenectomy, with either gastrectomy (Whipple procedure) or pylorus-preserving pancreaticoduodenectomy (PPPD), is a complex procedure. Technical diversity, variation and sampling bias exist among surgeons. Previous reports comparing these two procedures are retrospective and not randomized. These factors should be considered seriously and eliminated in comparisons between the two procedures.
                From August 1994 to August 1997, a prospective randomized comparison was conducted between the Whipple procedure and PPPD performed by the same surgeon with the same approach and same anastomotic fashion for periampullary cancer. After exclusion of seven patients, 31 patients were eligible for the study, 16 receiving PPPD and 15 a Whipple procedure. No significant difference in the age, sex distribution, tumour localization or staging was noted between the two groups.
                One operative death after PPPD and no operative death after the Whipple procedure resulted in a 3 per cent mortality rate in the 31 patients. Median duration of the Whipple operation was 235 (range 195-305) min, with a median blood loss of 500 (range 230-3100) ml and a median blood transfusion of 0 (range 0-10) units. In the patients who had PPPD, median operating time was 230 (range 170-275) min, median blood loss was 350 (range 100-1200) ml and median blood transfusion was 0 (range 0-4) units. There were two minor leaks from the pancreaticojejunostomy after the Whipple procedure and no leakage after PPPD, resulting in 6 per cent minor leakage in 31 patients. These outcomes were not significantly different. Delayed gastric emptying was observed more frequently after PPPD (six of 16 patients) than after the Whipple procedure (one of 15 patients), with marginal significance (P = 0.08, two-sided Fisher's exact test).
                In this prospective randomized study, both PPPD and the Whipple procedure were associated with low mortality and operative morbidity rates. There was no significant difference between PPPD and Whipple resection in terms of operative mortality and morbidity, operating time, blood loss and blood transfusion. PPPD was associated with more frequent delayed gastric emptying, although study of more patients is needed to confirm this. A prospective randomized multicenter study was performed to assess whether the results of pylorus-preserving pancreaticoduodenectomy (PPPD) equal those of the standard Whipple (SW) operation, especially with respect to duration of surgery, blood loss, hospital stay, delayed gastric emptying (DGE), and survival.
                PPPD has been associated with a higher incidence of delayed gastric emptying, resulting in a prolonged period of postoperative nasogastric suctioning. Another criticism of the pylorus-preserving pancreaticoduodenectomy for patients with a malignancy is the radicalness of the resection. On the other hand, PPPD might be associated with a shorter operation time and less blood loss.
                A prospective randomized multicenter study was performed in a nonselected series of 170 consecutive patients. All patients with suspicion of pancreatic or periampullary tumor were included and randomized for a SW or a PPPD resection. Data concerning patients' demographics, intraoperative and histologic findings, as well as postoperative mortality, morbidity, and follow-up up to 115 months after discharge, were analyzed.
                There were no significant differences noted in age, sex distribution, tumor localization, and staging. There were no differences in median blood loss and duration of operation between the 2 techniques. DGE was observed equally in the 2 groups. There was only a marginal difference in postoperative weight loss in favor of the standard Whipple procedure. Overall operative mortality was 5.3%. Tumor positive resection margins were found for 12 patients of the SW group and 19 patients of the PPPD group (P < 0.23). Long-term follow-up showed no significant statistical differences in survival between the 2 groups (P < 0.90).
                The SW and PPPD operations were associated with comparable operation time, blood loss, hospital stay, mortality, morbidity, and incidence of DGE. The overall long-term and disease-free survival was comparable in both groups. Both surgical procedures are equally effective for the treatment of pancreatic and periampullary carcinoma. The Whipple operation (PD) is the standard operation in patients with cancer of the head of the pancreas and the periampullary region. However, the pylorus-preserving duodenopancreatectomy (PPPD) is supposed to be superior in gastrointestinal function.
                In a prospective randomized trial (October 1994-October 1998) PD and PPPD were compared in terms of global and gastrointestinal quality of life, operation time, duration of hospital stay, transfusions and perioperative morbidity. Quality of life was analyzed under standardized conditions (EORTC-QLQ-30) pre- and postoperatively (weeks 2, 6, 12, 24, 36, 48, and 60).
                A duodenopancreatectomy was performed in 48 patients because of cancer of the head of the pancreas (n = 38) and the periampullary region (n = 10) (PD, n = 24; PPPD, n = 24). The PD and PPPD groups did not differ according to age, gender or UICC stage. Operation time was shorter in the PPPD group (206 +/- 48 vs 306 +/- 54 min) (P < 0.05). Morbidity did not differ between the two groups (PPPD 20% vs PD 30%, P > 0.05). While there was no difference in global quality of life, gastrointestinal quality of life was postoperatively increased in the PPPD group regarding appetite, nausea and diarrhea (P < 0.05). While the preoperative body weight was reached after 6 months in 85% of the PPPD group (n = 20), this was true in only 60% of the PD-group (n = 14) (P < 0.05).
                PPPD seems to be associated with a better postoperative gastrointestinal quality of life than PD. It is not known whether pylorus-preserving duodenopancreatectomy is as effective as the classical Whipple procedure in the resection of pancreatic and periampullary tumours. A prospective randomized trial was undertaken to compare the results of the two procedures.
                Clinical data, histological findings, short-term results, survival and quality of life of all patients having surgery for suspected pancreatic or periampullary cancer between June 1996 and September 2001 were analysed.
                Two hundred and fourteen patients were randomized to undergo either a standard or a pylorus-preserving Whipple resection. After exclusion of 84 patients on the basis of intraoperative findings, 130 patients (66 standard Whipple operation and 64 pylorus-preserving resection) were entered into the trial. Of these, 110 patients with proven adenocarcinoma (57 standard Whipple and 53 pylorus-preserving resection) were analysed for long-term survival and quality of life. There was no difference in perioperative morbidity. Long-term survival, quality of life and weight gain were identical after a median follow-up of 63.1 (range 4-93) months. At 6 months, capacity to work was better after the pylorus-preserving procedure (77 versus 56 per cent; P = 0.019).
                Both procedures were equally effective for the treatment of pancreatic and periampullary cancer. Pylorus-preserving Whipple resection offers some minor advantages in the early postoperative period, but not in the long term.
                Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
There is no evidence of relevant differences in mortality, morbidity and survival between the two operations. Given obvious clinical and methodological heterogeneity, future research must be undertaken to perform high-quality randomised controlled trials of complex surgical interventions on the basis of well-defined outcome parameters.