腹腔镜胰十二指肠切除术在老年胰腺导管腺癌患者中的肿瘤学疗效研究

目的 研究腹腔镜胰十二指肠切除术在老年胰腺导管腺癌患者中的肿瘤学疗效.方法 回顾性分析自2015年1月-2017年12月在复旦大学附属华东医院普外科完成胰十二指肠切除术治疗的胰腺导管腺癌、年龄≥60岁患者的临床资料.根据其手术方式分为腹腔镜(LPD)组与开放(OPD)组,并对2组的手术及肿瘤学资料进行比较.结果 共入组...     

Moving towards the New International Study Group for Pancreatic Surgery (ISGPS) definitions in pancreaticoduodenectomy: a comparison between the old and new

BackgroundThe International Study Group for Pancreatic Surgery (ISGPS) has proposed several definitions for postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE) and post-pancreatectomy haemorrhage (PPH). We assessed the effects of implementing these definitions on predicting outcomes.MethodsA database of 77 patients who underwent pancreaticoduodenectomy between January 2005 and December 2009 was analysed. Morbidities were defined and classified using the ISGPS definitions and recalculated based on the definitions adopted by our institution (‘Old’ definitions) prior to the implementation of ISGPS definitions. Data for the two groups were then compared.ResultsThe morbidity rate rose to 70.1% from 27.2% when ISGPS rather than Old definitions were used to define morbidities (P < 0.001). Incidences of DGE, POPF and PPH were 20.7%, 39.0% and 10.4%, respectively. Rates of DGE and POPF were significantly higher according to ISGPS definitions than to Old definitions (20.7% vs. 5.2% [P= 0.001] and 39.0% vs. 15.6% [P= 0.004], respectively). According to the ISGPS definitions, all of the 12 additional patients with DGE and 12 of the 18 additional patients with POPF had grade A morbidities. Patients with ISGPS-defined morbidity had a longer intensive care unit (ICU) stay, longer postoperative stay and longer total stay (P= 0.030, P= 0.007 and P= 0.001, respectively).ConclusionsThe morbidity rate more than doubled when ISGPS definitions were applied (an additional 42.9% of patients demonstrated morbidities). The majority of patients with DGE and POPF had grade A morbidities. The ISGPS definitions correlate well with ICU stay, postoperative stay and total length of stay.Use of ISGPS definitions increased markedly the morbidity rate in patients undergoing pancreatic resection and correlated well with hospital stay     

The effect of adjuvant and neoadjuvant chemo(radio)therapy on survival in 1,679 resected pancreatic carcinoma cases in Japan: report of the national survey in the 34th annual meeting of Japanese Society of Pancreatic Surgery

Background

Pancreatic carcinoma causes more than 20,000 deaths every year in Japan. The role of (neo-) adjuvant chemotherapy for pancreatic carcinoma is still controversial.

Methods

At the 34th Annual Meeting of the Japanese Society of Pancreatic Surgery in 2007, questionnaires were distributed regarding the use of (neo-) adjuvant chemo(radio)therapy for pancreatic carcinoma between 2001 and 2005.

Results

Sixty of the 146 member institutions responded to the questionnaires. There were a total of 1,846 cases of resected pancreatic carcinoma between 2001 and 2005. The study population had a greater proportion of males, and a mean age of 65.3 years (range 34–90 years). The lesion was located in the head of the pancreas in 1,204 cases (71.7%), in the body in 353 cases (21.0%), and in the tail in 111 cases (6.6%). Overall survival rates were 67.3% at 1 year, 36.0% at 2 years, and 23.9% at 3 years, respectively. Adjuvant chemotherapy (usually involving gemcitabine) was used in 66.0% of cases. The use of adjuvant chemotherapy was found to improve the overall survival rate. Interestingly, adjuvant chemotherapy only improved survival in late-stage (UICC stages IIB, III, and IV) but not early stage (IA, IB, and IIA) patients. Survival was treatment duration-dependent, with patients who received more than 12 months of therapy having a 3-year survival rate of 51.2%.

Conclusion

This high volume retrospective data indicated the promising effect of gemcitabine-based adjuvant chemotherapy and the rational duration of adjuvant chemotherapy should be determined in the future prospective studies.     

Unique treatment policy for well-differentiated thyroid cancer in Japan: results of a questionnaire distributed to members of the Japanese Society of Thyroid Surgery and the International Association of Endocrine Surgeons

Although surgery has been the mainstay of treatment for patients with well-differentiated thyroid cancer, the extents of thyroid resection and lymph node dissection adopted in Japan differ from those in other countries. Furthermore, regarding the indications for postoperative radiation therapy and hormonal therapy, and treatment modalities for cancer recurrence, there are marked discrepancies between Japan and other countries. A questionnaire survey was thus conducted among domestic and overseas thyroid surgeons to ascertain the actual treatment policy for well-differentiated thyroid cancer in Japan and various foreign countries. For small papillary carcinomas of 2.0 cm or less (T1), thyroid resection was more extensive in foreign countries than in Japan, although the extent of lymph node dissection was limited in the former. For large papillary carcinomas exceeding 3.0 cm (T2), on the other hand, total thyroidectomy was the treatment of first choice for all overseas respondents, but of only 20% in Japan, despite lymph node dissection being more extensive in Japan than in other countries. Overseas surgeons were much more likely to favor postoperative TSH suppression therapy and high-dose (131)I therapy. For recurrence following surgery for papillary thyroid cancer, both domestic and overseas respondents indicated surgical resection to be the most common treatment option, and favored high-dose (131)I therapy as well. In Japan, however, high-dose (131)I therapy is available only in a few institutions. Such limited indications for high-dose (131)I therapy in Japan may reflect a discrepancy in the frequency of total thyroidectomy, a prerequisite for postoperative high-dose (131)I therapy, between Japan and other countries. This is the first questionnaire study conducted in both Japan and other countries in relation to treatment modalities for thyroid cancer. The results reveal that there is a clear disparity in treatment policies between Japan and foreign countries.     

The selection of pancreatic reconstruction techniques gives rise to higher incidences of morbidity: results of the 30th Japan Pancreatic Surgery Questionnaire Survey on pancreatoduodenectomy in Japan

Background/Purpose

We aimed to determine the impact of the surgical strategy used for pancreatic reconstruction on morbidity after pancreatoduodenectomy (PD).

Methods

A questionnaire was sent to all surgeon members of the Japan Pancreatic Surgery Club in December 2002.

Results

We received 152 replies, and the data from all of them were used in the analysis. Thirty-six percent of the 152 responders performed PD and selected from among two or more pancreatic reconstruction techniques (PRTs). PRT selection was used no more frequently in the high- and medium-hospital-volume institutions than in low-hospital-volume institutions (25% or 37% vs 35%). The incidence of both “all arterial hemorrhage” and “delayed arterial hemorrhage” after PD in the institutions that used multiple PRTs was significantly higher than that in the institutions where only a single PRT was used (4.2% vs 2.2%, and 3.3% vs 1.5%, respectively; P < 0.05). In the high- and medium-hospital-volume institutions, the incidence of all arterial hemorrhage after PD in the multiple-PRT institutions was significantly higher than that in the single-PRT institutions (4.0% vs 1.9%; P < 0.05). Furthermore, in the low-hospital-volume institutions, the incidence of delayed arterial hemorrhage, 7 or more days after PD, was clearly higher in the multiple-PRT institutions than in the single-PRT institutions (4.1% vs 1.4%; P = 0.056). Therefore, the hospital-case volumes of PD were distributed as practice-case volumes according to the PRT by the selection of PRTs, and PRT selection gave rise to higher incidences of morbidity as a result of pancreatic leakage after PD.

Conclusions

The hospital-case-volume — better outcome relation for PD was attributable to expert pancreatic reconstruction skills that can be mastered only through frequent repetition.     

Role of adjuvant surgery for patients with initially unresectable pancreatic cancer with a long-term favorable response to non-surgical anti-cancer treatments: results of a project study for pancreatic surgery by the Japanese Society of Hepato-Biliary-Pancreatic Surgery

Purpose

A multicenter survey was conducted to explore the role of adjuvant surgery for initially unresectable pancreatic cancer with a long-term favorable response to non-surgical cancer treatments.

Methods

Clinical data including overall survival were retrospectively compared between 58 initially unresectable pancreatic cancer patients who underwent adjuvant surgery with a favorable response to non-surgical cancer treatments over 6 months after the initial treatment and 101 patients who did not undergo adjuvant surgery because of either unchanged unresectability, a poor performance status, and/or the patients’ or surgeons’ wishes.

Results

Overall mortality and morbidity were 1.7 and 47 % in the adjuvant surgery group. The survival curve in the adjuvant surgery group was significantly better than in the control group (p < 0.0001). The propensity score analysis revealed that adjuvant surgery was a significant independent prognostic variable with an adjusted hazard ratio (95 % confidence interval) of 0.569 (0.36–0.89). Subgroup analysis according to the time from initial treatment to surgical resection showed a significant favorable difference in the overall survival in patients who underwent adjuvant surgery over 240 days after the initial treatment.

Conclusion

Adjuvant surgery for initially unresectable pancreatic cancer patients can be a safe and effective treatment. The overall survival rate from the initial treatment is extremely high, especially in patients who received non-surgical anti-cancer treatment for more than 240 days.     

A nomogram predicting disease-free survival in patients with colorectal liver metastases treated with hepatic resection: multicenter data collection as a Project Study for Hepatic Surgery of the Japanese Society of Hepato-Biliary-Pancreatic Surgery

Background/purpose

The aim of this study was to create a nomogram to predict the disease-free survival of patients with colorectal liver metastases treated with hepatic resection.

Methods

Perioperative factors were assessed in 727 hepatectomized patients with colorectal liver metastases between 2000 and 2004 at the 11 institutions of the ??Project Committee of the Liver?? in the Japanese Society of Hepato-Biliary-Pancreatic Surgery. A nomogram was developed as a graphical representation of a stepwise Cox proportional hazards regression model.

Results

Perioperative mortality was 0.55%. Disease-free and overall survival rates were 31.2 and 63.8% at 3?years, 27.2 and 47.7% at 5?years, and 24.7 and 38.5% at 10?years, respectively. Six preoperative factors were selected to create the nomogram for disease-free survival: synchronous metastases, 3 points; primary lymph node positive, 3 points; number of tumors 2?C4, 4 points and ??5, 9 points; largest tumor diameter >5?cm, 2 points; extrahepatic metastasis at hepatectomy, 4 points, and preoperative carbohydrate antigen 19-9 level >100, 4 points. The estimated median disease-free survival time was easily calculated by the nomogram: >8.4?years for patients with 0 points, 1.9?years for 5 points, 1.0?years for 10 points, and the rates were lower than 0.6?years for patients with more than 10 points.

Conclusions

This nomogram can easily calculate the median and yearly disease-free survival rates from only 6 preoperative variables. This is a very useful tool to determine the likelihood of early recurrence and the necessity for perioperative chemotherapy in patients with colorectal liver metastases after hepatic resection.     

Predictive risk factors for clinically relevant pancreatic fistula analyzed in 1,239 patients with pancreaticoduodenectomy: multicenter data collection as a project study of pancreatic surgery by the Japanese Society of Hepato-Biliary-Pancreatic Surgery

Background/purpose

It is important to predict the development of clinically relevant pancreatic fistula (grade B/C) in the early period after pancreaticoduodenectomy (PD). This study has been carried out as a project study of the Japanese Society of Hepato-Biliary-Pancreatic Surgery (JSHPBS) to evaluate the predictive factors associated with clinically relevant pancreatic fistula (grade B/C).

Method

The data of 1,239 patients from 11 medical institutions who had undergone PD between July 2005 and June 2009 were retrospectively analyzed to review patient characteristics and perioperative and postoperative parameters.

Results

A drain amylase level >4,000 IU/L on postoperative day (POD) 1 was proposed as the cut-off level to predict clinical relevant pancreatic fistula by the receiver operating characteristic (ROC) curve. The sensitivity, specificity, and accuracy of this cut-off level were 62.2, 89.0, and 84.8%, respectively. A multivariate logistic regression analysis revealed that male [odds ratio (OR) 1.7, P = 0.039], intraoperative bleeding >1,000 ml (OR 2.5, P = 0.001), soft pancreas (OR 2.7, P = 0.001), and drain amylase level on POD 1 >4,000 IU/L (OR 8.6, P < 0.001) were the significant predictive factors for clinical pancreatic fistula.

Conclusion

The four predictive risk factors identified here can provide useful information useful for tailoring postoperative management of clinically relevant pancreatic fistula (grade B/C).     

Improving survival with deferiprone treatment in patients with thalassemia major: A prospective multicenter randomised clinical trial under the auspices of the Italian Society for Thalassemia and Hemoglobinopathies

The prognosis for thalassemia major has dramatically improved in the last two decades. However, many transfusion-dependent patients continue to develop progressive accumulation of iron. This can lead to tissue damage and eventually death, particularly from cardiac disease. Previous studies that investigated iron chelation treatments, including retrospective and prospective non-randomised clinical trials, suggested that mortality, due mainly to cardiac damage, was reduced or completely absent in patients treated with deferiprone (DFP) alone or a combined deferiprone–deferoxamine (DFP–DFO) chelation treatment. However, no survival analysis has been reported for a long-term randomised control trial. Here, we performed a multicenter, long-term, randomised control trial that compared deferoxamine (DFO) versus DFP alone, sequential DFP–DFO, or combined DFP–DFO iron chelation treatments. The trial included 265 patients with thalassemia major, with 128 (48.3%) females and 137 (51.7%) males.No deaths occurred with the DFP-alone or the combined DFP–DFO treatments. One death occurred due to graft versus host disease (GVHD) in a patient that had undergone bone marrow transplantation; this patient was censored at the time of transplant. Only one death occurred with the DFP–DFO sequential treatment in a patient that had experienced an episode of heart failure one year earlier. Ten deaths occurred with the deferoxamine treatment.The main factors that correlated with an increase in the hazard ratio for death were: cirrhosis, arrhythmia, previous episode of heart failure, diabetes, hypogonadism, and hypothyroidism. In a Cox regression model, the interaction effect of sex and age was statistically significant (p-value < 0.013). For each increasing year of age, the hazard ratio for males was 1.03 higher than that for females (p-value < 0.013).In conclusion, the results of this study show that the risk factors for predicting mortality in patients with thalassemia major are deferoxamine-treatment, complications, and the interaction effect of sex and age.     

Significance of hepatic resection and adjuvant hepatic arterial infusion chemotherapy for hepatocellular carcinoma with portal vein tumor thrombus in the first branch of portal vein and the main portal trunk: a project study for hepatic surgery of the Japanese Society of Hepato‐Biliary‐Pancreatic Surgery

Background

The prognosis of hepatocellular carcinoma (HCC) with tumor thrombus in the major portal vein (PV) is extremely poor. The purpose of this study was to clarify the impact of hepatic resection for HCC with tumor thrombus in the major PV.

Patients

Four hundred patients undergoing macroscopic curative resection for HCC involving the first branch or trunk of the PV between 2001 and 2010 at the 22 institutions were enrolled. We examined the effect of adjuvant hepatic arterial infusion chemotherapy (HAIC) on prognosis and validated the prognostic index consisting of ascites, prothrombin activity, and maximal tumor diameter.

Results

Median survival time (MST) and 5‐year overall survival rate were 21.5 months and 25.7%. MST of HAIC group was longer than that of non‐HAIC group (28.1 months vs. 18.7 months, P = 0.0024). Significant prognostic factors for overall survival were PIVKA‐II, tumor diameter, and adjuvant HAIC. MST for patients with prognostic index 0, 1, 2, and 3 was 39.0, 21.1, 18.9, and 5.7 months, respectively (P = 0.005).

Conclusions

Macroscopic curative resection with adjuvant HAIC might provide better survival outcome. Furthermore, the prognostic index was useful to select adequate treatment modalities for patients with HCC with tumor thrombosis in the major PV.     

The current status of treatment‐related severe hypoglycemia in Japanese patients with diabetes mellitus: A report from the committee on a survey of severe hypoglycemia in the Japan Diabetes Society

Despite great strides in pharmacotherapy for diabetes, there is increasing concern over the risk of hypoglycemia in patients with diabetes receiving pharmacotherapy as they become increasingly older. This has prompted the Japan Diabetes Society (JDS) to initiate a survey on the current status of severe hypoglycemia in clinical settings. In July 2015, following approval from the JDS Scientific Survey/Research Ethics Committee, the JDS extended an invitation to executive educators, who represented a total of 631 healthcare facilities accredited by the JDS for diabetes education, to participate in the proposed survey. Of these, those who expressed their willingness to participate in the survey were sent an application form required for obtaining ethical approval at these healthcare facilities and were then asked, following approval, to enter relevant clinical data on an unlinked, anonymous basis in a web‐based registry. The current survey was fully funded by the JDS Scientific Survey/Research Committee. A case registry (clinical case database) was launched after facility‐specific information (healthcare facility database) was collected from all participating facilities and after informed consent was obtained from all participating patients. With severe hypoglycemia defined as the “presence of hypoglycemic symptoms requiring assistance from another person to treat and preferably venous plasma glucose levels at onset/diagnosis of disease or at presentation clearly less than 60 mg/dL (capillary whole blood glucose, less than 50 mg/dL)”, the current survey was conducted between April 1, 2014 and March 31, 2015, during which facility‐specific information was collected from a total of 193 facilities with a total of 798 case reports collected from 113 facilities. Of the 193 respondent facilities, 149 reported having an emergency department as well, with the median number of patients who required emergency transportation services to reach these facilities totaling 4,962 annually, of which those with severe hypoglycemia accounted for 0.34% (17). The respondent facilities accommodated a total of 2,237 patients with severe hypoglycemia annually, with the number of patients thus accommodated being 6.5 patients per site. A total of 1,171 patients were admitted for severe hypoglycemia, with the number of patients thus admitted being 4.0 per site, who accounted for 52.3% of all patients visiting annually for severe hypoglycemia. A review of the 798 case reports collected during the survey revealed that 240, 480 and 78 patients had type 1 diabetes, type 2 diabetes, and other types of diabetes, respectively; those with type 2 diabetes were shown to be significantly older (median [interquartile range], 77.0 [68.0–83.0]) than those with type 1 diabetes (54.0 [41.0–67.0]) (P < 0.001); and the BMI was shown to be significantly higher for those with type 2 diabetes (22.0 [19.5–24.8] kg/m²) than for those with type 1 diabetes (21.3 [18.9–24.0] kg/m²) (P = 0.003). It was also found that the median estimated glomerular filtration rate (eGFR) was significantly lower among those with type 2 diabetes (50.6 mL [31.8–71.1]/min/1.73 m²) than among those with type 1 diabetes (73.3 [53.5–91.1] mL/min/1.73 m²) (P < 0.001). Again, the median HbA1c value at onset of severe hypoglycemia was shown to be 7.0 (6.3–8.1)% among all patients examined, 7.5 (6.9–8.6)% among those with type 1 diabetes, and 6.8 (6.1–7.6)% among those with type 2 diabetes, with the HbA1c value at onset of hypoglycemia being significantly lower among those with type 2 diabetes (P < 0.001). Antecedent symptoms of severe hypoglycemia were shown to be present, absent and unknown in 35.5, 35.6, and 28.9% of all patients, respectively, with the incidence of symptomatic hypoglycemia being significantly lower among those with type 1 diabetes (41.0%) than among those with type 2 diabetes (56.9%). The antidiabetic agents used in those with type 2 diabetes were insulin preparations (292 patients including 29 receiving concomitant sulfonylureas [SUs]) (60.8%), SUs (159 insulin‐naïve patients) (33.1%), and no insulin preparations or SUs (29 patients) (6.0%). Of the 798 patients surveyed, 296 patients (37.2%) were shown to have required emergency transportation services for severe hypoglycemia before. Thus, the survey revealed, for the first time, the current status of treatment‐related severe hypoglycemia in Japan and clearly highlights the acute need for implementing preventive measures against hypoglycemia not only through education on hypoglycemia but through optimization of antidiabetic therapy for those at high risk of severe hypoglycemia or those with a history of severe hypoglycemia.