Clinical surgery
A controlled randomized multicenter trial of pancreatogastrostomy or pancreatojejunostomy after pancreatoduodenectomy

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Abstract

Background

Only 2 large (more than 100 patients) prospective trials comparing pancreatogastrostomy (PG) with pancreatojejunostomy (PJ) after pancreatoduodenectomy (PD) have been reported until now. One nonrandomized study showed that there were less pancreatic and digestive tract fistula with PG, whereas the other, a randomized trial from a single high-volume center, found no significant differences between the two techniques.

Methods

Single blind, controlled randomized, multicenter trial. The main endpoint was intra-abdominal complications (IACs).

Results

Of 149 randomized patients, 81 underwent PG and 68 PJ. No significant difference was found between the two groups concerning pre- or intraoperative patient characteristics. The rate of patients with one or more IACs was 34% in each group. Twenty-seven patients sustained a pancreatoenteric fistula (18%), 13 in PG (16%; 95% confidence interval [CI] 8–24%) and 14 in PJ (20%; 95% CI 10.5–29.5%). No statistically significant difference was found between the 2 groups concerning the mortality rate (11% overall), the rate of reoperations and/or postoperative interventional radiology drainages (23%), or the length of hospital stay (median 20.5 days). Univariate analysis found the following risk factors: (1) age ≥70 years old, (2) extrapancreatic disease, (3) normal consistency of pancreas, (4) diameter of main pancreatic duct <3 mm, (5) duration of operation >6 hours, and (6) a center effect. Significantly more IAC, pancreatoenteric fistula, and deaths occurred in one center (that included the most patients) (P = .05), but there were significantly more high-risk patients in this center (normal pancreas consistency, extrapancreatic pathology, small pancreatic duct, higher transfusion requirements, and duration of operation >6 hours) compared with the other centers. In multivariate analysis, the center effect disappeared. Independent risk factors included duration of operation >6 hours for IAC and for pancreatoenteric fistula (P = .01), extrapancreatic disease for pancreatoenteric fistulas (P < .04), and age ≥70 years for mortality (P < .02).

Conclusions

The type of pancreatoenteric anastomosis (PJ or PG) after PD does not significantly influence the rate of patients with one or more IAC and/or pancreatic fistula or the severity of complications.

Section snippets

Patients

Between September 1995 and December 1999 (ie, 52 months), 149 consecutive patients (86 men and 63 women, mean age 58.4 ± 11 years (range 22–76 years), undergoing PD, whether for pancreatic (malignant or benign) tumor or chronic pancreatitis or for extrapancreatic tumor (ampullar, biliary, or duodenal), were included in this multicenter trial. Fourteen surgical centers participated (8 university and 6 nonuniversity community hospitals). The initial and final dates of participation differed from

Results

Of 149 patients randomized, 81 underwent PG and 68 underwent PJ. There were no protocol violations, no crossovers, or withdrawals after randomization.

Comments

Our study shows that the type of pancreatoenteric anastomosis (PJ or PG) after PD does not statistically significantly influence either the rate of patients with one or more IACs, the rate of pancreatoenteric fistula, or the severity of complications (Table 3). In multivariate analysis, 2 independent risk factors were found: duration of operation longer than 6 hours (P = .01) and age ≥70 years (P < .02).

Our multicenter study confirmed the results of the only other monocenter, randomized trial

Conclusion

As suggested by the results of our study and those of Yeo et al [11], the best anastomosis after PD is probably the one with which the surgeon is most familiar. The multicenter character of our study confers wide applicability of results to nonspecialized, low-volume settings. In the future, the following technical artifices that might lower the rate of postoperative IAC and in particular of pancreatic fistula remain to be evaluated by randomized trials: preoperative radiation therapy [19], [23]

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    A complete list of the collaborators in the French Associations for Research in Surgery appears in Appendix 1.

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