Postoperative complications, especially pulmonary complications, affect more than half the patients who undergo open esophagectomy for esophageal cancer. Whether hybrid minimally invasive ...esophagectomy results in lower morbidity than open esophagectomy is unclear.
We performed a multicenter, open-label, randomized, controlled trial involving patients 18 to 75 years of age with resectable cancer of the middle or lower third of the esophagus. Patients were randomly assigned to undergo transthoracic open esophagectomy (open procedure) or hybrid minimally invasive esophagectomy (hybrid procedure). Surgical quality assurance was implemented by the credentialing of surgeons, standardization of technique, and monitoring of performance. Hybrid surgery comprised a two-field abdominal-thoracic operation (also called an Ivor-Lewis procedure) with laparoscopic gastric mobilization and open right thoracotomy. The primary end point was intraoperative or postoperative complication of grade II or higher according to the Clavien-Dindo classification (indicating major complication leading to intervention) within 30 days. Analyses were done according to the intention-to-treat principle.
From October 2009 through April 2012, we randomly assigned 103 patients to the hybrid-procedure group and 104 to the open-procedure group. A total of 312 serious adverse events were recorded in 110 patients. A total of 37 patients (36%) in the hybrid-procedure group had a major intraoperative or postoperative complication, as compared with 67 (64%) in the open-procedure group (odds ratio, 0.31; 95% confidence interval CI, 0.18 to 0.55; P<0.001). A total of 18 of 102 patients (18%) in the hybrid-procedure group had a major pulmonary complication, as compared with 31 of 103 (30%) in the open-procedure group. At 3 years, overall survival was 67% (95% CI, 57 to 75) in the hybrid-procedure group, as compared with 55% (95% CI, 45 to 64) in the open-procedure group; disease-free survival was 57% (95% CI, 47 to 66) and 48% (95% CI, 38 to 57), respectively.
We found that hybrid minimally invasive esophagectomy resulted in a lower incidence of intraoperative and postoperative major complications, specifically pulmonary complications, than open esophagectomy, without compromising overall and disease-free survival over a period of 3 years. (Funded by the French National Cancer Institute; ClinicalTrials.gov number, NCT00937456 .).
Although often investigated in locally advanced esophageal cancer (EC), the impact of neoadjuvant chemoradiotherapy (NCRT) in early stages is unknown. The aim of this multicenter randomized phase III ...trial was to assess whether NCRT improves outcomes for patients with stage I or II EC.
The primary end point was overall survival. Secondary end points were disease-free survival, postoperative morbidity, in-hospital mortality, R0 resection rate, and prognostic factor identification. From June 2000 to June 2009, 195 patients in 30 centers were randomly assigned to surgery alone (group S; n = 97) or NCRT followed by surgery (group CRT; n = 98). CRT protocol was 45 Gy in 25 fractions over 5 weeks with two courses of concomitant chemotherapy composed of fluorouracil 800 mg/m(2) and cisplatin 75 mg/m(2). We report the long-term results of the final analysis, after a median follow-up of 93.6 months.
Pretreatment disease was stage I in 19.0%, IIA in 53.3%, and IIB in 27.7% of patients. For group CRT compared with group S, R0 resection rate was 93.8% versus 92.1% (P = .749), with 3-year overall survival rate of 47.5% versus 53.0% (hazard ratio HR, 0.99; 95% CI, 0.69 to 1.40; P = .94) and postoperative mortality rate of 11.1% versus 3.4% (P = .049), respectively. Because interim analysis of the primary end point revealed an improbability of demonstrating the superiority of either treatment arm (HR, 1.09; 95% CI, 0.75 to 1.59; P = .66), the trial was stopped for anticipated futility.
Compared with surgery alone, NCRT with cisplatin plus fluorouracil does not improve R0 resection rate or survival but enhances postoperative mortality in patients with stage I or II EC.
Background The influence of jaundice on outcomes after pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC) is debated. This study aimed to determine, in a large multicentric ...series, the influence of severe jaundice (serum bilirubin level ≥250 μmol/L and 300 μmol/L) on early severe morbidity and survival after PD. Study Design From 2004 to 2009, twelve hundred patients (median age 66 years, 57% male) with resectable PDAC underwent PD. Patients who received preoperative biliary drainage for neoadjuvant treatment or cholangitis were excluded. Pre- and intraoperative data were collected by a standardized form. Serum bilirubin level and creatinine clearance were analyzed as categorical variables. Predictive factors of severe complications and poor survival (Kaplan-Meier method) were identified by univariate and multivariate analysis. Results Median follow-up was 21 months (95% CI, 19-23). Operative mortality was 3.9% (n = 47), with no predictive factors in multivariate analysis. Severe complications (Dindo-Clavien grade III to IV) occurred in 22% (n = 268), with male sex (p = 0.025), America Society of Anesthesiologists score 3 to 4 (p = 0.022), serum bilirubin level ≥300 μmol/L (p = 0.034), and creatinine clearance <60 mL/min/1.73 m2 (p = 0.013) identified as predictive factors in multivariate analysis. Overall 3-year survival rate was 41% (95% CI, 37-45%). In multivariate analysis, serum bilirubin level ≥300 μmol/L (p = 0.048), low-volume center (p < 0.001), venous resection (p = 0.014), N1 status (p < 0.01), R1 status (p < 0.001), and absence of adjuvant treatment (p < 0.001) negatively impacted survival. There was a negative relationship between survival at 12 months or later and higher rates of bilirubin. Presence of a biliary stent did not influence early or long-term results. Conclusions In this multicentric study, serum bilirubin level ≥300 μmol/L increased severe morbidity and decreased long-term survival after PD for PDAC. These findings suggest that biliary stenting is appropriately indicated before PD in patients with PDAC and severe jaundice.
Background
Spontaneous rupture of hepatocellular carcinoma (HCC) remains a life-threatening complication, with a reported mortality rate of between 16 and 30% and an incidence rate of approximately ...3% in Europe. Survival data and risk factors after ruptured HCC are lacking, especially for peritoneal metastasis (PM).
Objectives
The aims of this study were to evaluate the pattern of recurrence and mortality after hepatectomy for ruptured HCC, and to focus on PM.
Methods
We retrospectively reviewed the files of patients admitted to 14 French surgical centers for spontaneous rupture of HCC between May 2000 and May 2012.
Results
Overall, 135 patients were included in this study. The median disease-free survival and overall survival (OS) rates were 16.1 (11.0–21.1) and 28.7 (26.0–31.5) months, respectively, and the median follow-up period was 29 months. At last follow-up, recurrences were observed in 65.1% of patients (
n
= 88). The overall rate of PM following ruptured HCC was 12% (
n
= 16). Surgical management of PM was performed for six patients, with a median OS of 36.6 months. An α-fetoprotein level > 30 ng/mL (
p
= 0.0009), tumor size at rupture > 70 mm (
p
= 0.0009), and vascular involvement (
p
< 0.0001) were found to be independently associated with an increased likelihood of recurrence. No risk factor for PM was observed.
Conclusion
This large-cohort French study confirmed that 12% of patients had PM after ruptured HCC. A curative approach may be an option for highly selected patients with exclusive PD because of the survival benefit it could provide.
Background
Ex vivo split liver transplantation in pediatric recipients has shown inferior results compared with whole grafts. One factor among others contributing to split grafts being considered as ...marginal is the prolonged static cold storage time related to ex vivo liver splitting. End ischemic hypothermic oxygenated perfusion is a validated strategy to improve outcomes of marginal whole grafts and may thus also benefit split liver grafts.
Method
We present the first case of full left/full right split procedure performed during hypothermic oxygenated perfusion.
Results
We present a standardized surgical two‐step approach where parenchymal transection was performed during end ischemic hypothermic oxygenated perfusion via the portal vein to shorten static cold storage duration. Both split grafts were successfully transplanted in a 4‐year‐old pediatric and a 38‐year‐old adult recipient. Despite high‐risk procedure (retransplantation), extended donor criteria including a prolonged cardiac arrest and high donor risk index (2,25), both grafts showed early recovery of hepatic function and low serum transaminase release. At 6 months, both recipients were alive with a normal liver biology and a functioning graft.
Conclusion
Although challenging, full left/full right liver split procedure during end ischemic hypothermic oxygenated perfusion can be successfully performed and is a promising strategy to improve post‐transplant outcomes.
Background
Acute pancreatitis (AP) can be one of the earliest clinical presentation of pancreatic ductal adenocarcinoma (PDAC). Information about the impact of AP on postoperative outcomes as well as ...its influences on PDAC survival is scarce. This study aimed to determine whether AP as initial clinical presentation of PDAC impact the short- and long-term outcomes of curative intent pancreatic resection.
Patients and methods
From 2004 to 2009, 1449 patients with PDAC underwent pancreatic resection in 37 institutions (France, Belgium and Switzerland). We used univariate and multivariate analysis to identify factors associated with severe complications and pancreatic fistula as well as overall and disease-free survivals.
Results
There were 764 males (52,7%), and the median age was 64 years. A total of 781 patients (53.9%) developed at least one complication, among whom 317 (21.8%) were classified as Clavien–Dindo ≥ 3. A total of 114 (8.5%) patients had AP as the initial clinical manifestation of PDAC. This situation was not associated with any increase in the rates of postoperative fistula (21.2% vs 16.4%,
P =
0.19), postoperative complications (57% vs 54.2%,
P =
0.56), and 30 day mortality (2.6% vs 3.4%,
P =
1). In multivariate analysis, AP did not correlate with postoperative complications or pancreatic fistula. The median length of follow-up was 22.4 months. The median overall survival after surgery was 29.9 months in the AP group and 30.5 months in the control group. Overall recurrence rate and local recurrence rate did not differ between groups.
Conclusion
AP before PDAC resection did not impact postoperative morbidity and mortality, as well as recurrence rate and survival.
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