Pancreatic stump leak following left sided resection remains common. Despite multiple and varied techniques for closure, the leak rate averages 30%. A retrospective review by Ferrone et al. detected a decreased leak rate in patients receiving a traditional closure buttressed with an autologous falciform ligament patch and fibrin glue. Methods: Between April 2008 and October 2011, all willing patients undergoing distal pancreatectomy at the authors' institutions, were consented and enrolled at the preoperative office visit. Patients were intraoperatively stratified as “hard” or “soft” glands and randomized to one of two groups: (1) closure utilizing standard stapling, suturing, or both (SS) versus (2) stapled, sutured, or both plus fibrin glue and falciform ligament patch (FF). The trial design and power analysis (α=0.05, β=0.2, power 80%, chi-square test) assumed the FF intervention would reduce the endpoint (pancreatic fistula) from 30% to 15% and yielded an accrual goal of 190 patients. Secondary endpoints included length of stay, mortality, readmission, and ISGPF fistula grade. Results: The trial accrued 109 patients, 55 in the control group and 54 in the experimental group. Enrollment was closed early, following an interim analysis and futility calculation. Due to insufficient enrollment, patients stratified as having a “hard” gland were excluded (n=8) from analysis, leaving 101 patients in the soft stratum. The pancreatic leak rate was 19.8% (20 patients) for patients with soft glands. Patients randomized to the FF group had a leak rate of 20% as compared with 19.6% in the SS group (p=1.000). Fistula grades in both groups were similar: 1A, 8B, and 1C compared to 1A, 8B and 1C in the FF and SS groups respectively. Complication rates were comparable between the two groups. The median length of postoperative hospital stay was 5 days in both groups. There was a trend towards a higher 30-day readmission rate in the FF group (28% vs. 17.6%, p= 0.243). Based on conditional probability calculations with 52.5% of enrollment, the probability of success of the trial given the current trend fell below 50%, and the trial was ended. Conclusion: The addition of a falciform ligament patch and fibrin glue to standard stapled or sutured remnant closure did not reduce the rate or severity of pancreatic fistula in patients undergoing distal pancreatectomy. (ClinicalTrials.gov number NCT00889213)
95% confidence interval: 25.7 - 72.3, P < 0.0001, Log-rank test, Figure 1). This cut-off represented the optimum distance for predicting long-term survival. Conclusion: These results demonstrate that margin clearance by at least 1.5 mm identifies a subgroup of patients with a particularly good outcome. Stratification of patients into future clinical trials based upon the degree of margin clearance may identify those patients likely to benefit from adjuvant therapy.
Kaplan Meier survival curves illustrating that a cut-off of greater than 1.5 mm identifies a subgroup of patents (15%) with pancreatic ductal adenocarcinoma with a good prognostic outcome following resection by pancreaticoduodenectomy. 818
Background: Although feasibility of total laparoscopic pancreatoduodenectomy (TLPD) has been established, a large scale study comparing the invasiveness of TLPD with open pancreatoduodenectomy (OPD) has never reported. Purpose: The purpose of this study was to investigate if TLPD can reduce the postoperative incidence of systemic inflammatory response syndrome (SIRS) compared with OPD. Methods: A single-institutional retrospective cohort study of all pancreaticoduodenectomy patients between 2007 and 2010 was performed. The incidence of SIRS was measured three times a day (at the nearest point of 8, 16 and 24 o'clock) from postoperative day (POD) 1 to POD 5. The incidence of SIRS on each POD was defined by meeting the criteria of SIRS at two or more points out of the daily three measurement points. Perioperative outcomes including the incidence of SIRS were compared between TLPD and OPD group. The relationship between the clinicopathological factors and the incidence of postoperative SIRS was investigated using univariate and multivariate analyses. Results: Five hundred twenty-seven consecutive patients (TLPD n = 125, OPD n = 402) were included in study. Six patients (5%) with conversion to OPD were included in TLPD group based on intent-to-treat. The reasons for conversion were the possibility of major venous resection (n = 3), bleeding (n = 1), severe adhesion (n = 1) and expected difficult reconstruction (n = 1). Compared with patients in the OPD group, those in the TLPD group had significantly less preoperative clinical jaundice (42% vs. 53%, P = 0.03), less adenocarcinoma (58% vs. 70%, P = 0.01), and smaller pancreatic duct size (3.7mm vs. 4.2mm, P = 0.002). Median estimated blood loss was less for the TLPD group than the OPD group (200ml vs. 600ml, P < 0.001). However, there were no differences in postoperative complication (62% vs. 67%, P = 0.3) or clinically relevant pancreatic leak (21% vs. 21%, P = 0.8). The incidence of SIRS in the TLPD group was significantly less than that of OPD group on POD 1 (9% vs. 24%, P < 0.001). Within a subset of 179 patients without postoperative complication, the incidence of SIRS in the TLPD group was significantly less than that of OPD group on POD 1 (2% vs. 13%, P = 0.01) and POD 2 (4% vs. 15%, P = 0.03). Multivariate analysis revealed that increased body mass index (> 27) (HR 1.7, 95% CI 1.1 - 2.6, P = 0.005), OPD (HR 1.8, 95% CI 1.1 - 2.9, P = 0.01) and postoperative complication (HR 2.3, 95% CI 1.4 - 3.7, P < 0.001) were independently associated with SIRS on POD 1 and/or 2. Conclusion: TLPD independently reduced the early incidence of SIRS after pancreatoduodenectomy. The laparoscopic approach to pancreatoduodenectomy appears to provide an advantage of less invasiveness compared with the open approach especially in patients that do not develop postoperative complications.
Table 1. Demographics of patients in the study (FF) and control (SS) group, showing no significant differences.
Table 2. Clinical outcomes of patients in the study (FF) and control (SS) group, showing no significant differences. 817 The Prognostic Influence of Resection Margin Clearance Following Pancreaticoduodenectomy for Pancreatic Ductal Adenocarcinoma Nigel B. Jamieson, Nigel Chan, Euan J. Dickson, Colin McKay, Ross Carter
819
Introduction: The poor overall survival associated with pancreatic ductal adenocarcinoma (PDAC) despite complete resection suggests that occult metastatic disease is present in most at the time of surgery. Resection margin involvement (R1) following resection is an established poor prognostic factor. However the definition of an R1 resection varies and the impact of margin clearance on outcome has not been examined in detail. Methods: In a cohort of 215 consecutive patients who underwent pancreaticoduodenectomy for PDAC with curative intent at a single institution between 1996-2010, the prognostic significance of the proximity of margin clearance was investigated. Microscopic margin clearance was stratified by 0.5 mm increments from tumor present to greater that 2 mm. Groups were dichotomized into clear and involved groups according to the different R1 definitions. Multivariate survival analysis was used to establish independent prognostic factors. Clearance of individual margins was also considered. Results: Stratification of the minimal clearance distance revealed that there was no significant difference in the outcome of patients with tumor ≤ 1 mm from the margin when compared to those with tumor ≤ 0.5 mm from the margin (P = 0.67, Log-rank test). For the 32 patients (15%) where the tumor was > 1.5 mm from the closest involved margin there was a significantly prolonged overall survival (median 49.0 months
Predictors of Recurrence in Intraductal Papillary Mucinous Neoplasm: Experience With 208 Pancreatic Resections Megan Winner, Irene Epelboym, Joseph DiNorcia, Minna K. Lee, James A. Lee, Beth Schrope, John A. Chabot, John D. Allendorf Background: Intraductal papillary mucinous neoplasm (IPMN) is being diagnosed and resected with increasing frequency, but little long-term data exist to guide postoperative management of surgically treated patients. Methods: We examined all patients who underwent surgical resection for IPMN between January 1997 and April 2011 at our institution. IPMN was categorized as non-invasive low grade (adenoma and borderline dysplasia), non-invasive high grade (carcinoma in situ), or invasive. Histologic features of primary and recurrent disease were examined and we evaluated predictors of recurrence using Kaplan Meier curves and Cox proportional hazards models. Results: Two hundred and eight patients underwent resection for IPMN. At presentation, 57% were symptomatic, 20% had a mural nodule or an associated mass, and median cyst size was 1.8cm. Sixty-eight (32.7%) operations for high grade disease were performed, of which 33 revealed invasive carcinoma. Among 165
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SSAT Abstracts
SSAT Abstracts
Incidence of Systemic Inflammatory Response Syndrome After Total Laparoscopic Pancreatoduodenectomy - a Comparison With Open Pancreatoduodenectomy Naru Kondo, Clancy J. Clark, Florencia G. Que, Kaye M. Reid Lombardo, David M. Nagorney, John H. Donohue, Michael B. Farnell, Michael L. Kendrick