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There have been many cases of PD since the first report by Wipple et al. PD may cause considerable complications, including pancreatic fistula, intra-abdominal bleeding, intra-abdominal abscess, sepsis and organ failure, and requires high-quality techniques and management methods in the perioperative period. However, the rate of morbidity and mortality associated with PD has decreased, especially in high-volume centers [ 6 — 8 ]. Complications tend to be lower in institutions that perform more than a certain number of surgeries and have more than a certain number of staff medical specialists; such institutions provide better management of complications, which provides the strength of the recommendation.

It was suggested that PD was contraindicated in most elderly patients, because such aggressive surgery would result in perioperative complications. Yeo et al [ 17 ] noted that age appears to be an important predictor of death in low-volume centers but not in high-volume centers. Several studies reported that age was not an independent risk factor for perioperative mortality and morbidity following PD [ 11 , 18 ]. Since PD is the only chance these patients have for a cure, we suggest that PD is justified, even in the elderly.

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If appropriate management of elderly patients is provided, the safety of perioperative management will be secured in high-volume centers. Therefore, it has been reported that patients should not be excluded from PD due to age [ 10 ]. In our institution, we also investigated the safety of elderly patients following PD. Patients aged 75 years and older group A had remarkably similar outcomes compared to younger patients group B , with no differences in patient characteristics and preoperative laboratory data, excluding albumin.

Moreover, there was no difference in morbidity and mortality between groups. It was suggested that this was because a portal vein resection was done for only 1 of 31 patients 3. Pancreatic fistula is the most threatening complication of PD. In the present study, the incidence of pancreatic fistula was similar between older and younger patients Several reports compared external drainage and no-stent procedures and found that the incidence of fistula was significantly lower for external drainage [ 3 , 19 ].

The normal pancreas preserves exocrine function, and its main pancreatic duct is narrow. Thus, one cannot rule out the possibility of injury during surgical manipulation.

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The diameter of the pancreatic duct is approximately mm in the normal pancreas, and postoperative swelling can develop temporarily that can result in stenosis. Thus, stent placement is considered essential at our institution. It is thought that placement of an external drain can minimize the leakage from a branch of remnant pancreatic duct. The external drain reduces the stress at the anastomotic site by a pressure gradient and minimizes the outflow into the branch of the pancreatic duct.

We placed an external drain for the normal pancreas. We suggest that an external drain reduces the incidence of pancreatic fistula in a normal pancreas. Older patients also had similar lengths of postoperative hospital stay compared with younger patients. The rate of overall survival in older patients tended to be lower compared with younger patients, though the difference was not statistically significant.

Recently, most patients with pancreatic carcinoma receive adjuvant chemotherapy [ 20 ]. It is difficult to compare older and younger patients, as we did not manage some older patients after surgery, because we considered the side effects of chemotherapy due to their age, especially for those over 80 years of age.

Aloia et al report delayed recovery after PD [ 21 ]. Because patient age was independently associated with a decreased likelihood of receiving adjuvant therapy by multivariate analysis, we suggest that it might be better to avoid adjuvant chemotherapy after surgery for elderly patients. Except for this matter, our data showed no significant differences in postoperative morbidity and mortality between older and younger PD patients.


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The results of several series [ 22 — 26 ] suggest that age is unrelated to morbidity and mortality and that PD can be performed safely if it is provided by appropriate indication and management. Our study also addresses the safety of PD management in elderly patients and supports these opinions. In conclusion, it cannot be ignored that the elderly population is getting larger.

This article is published under license to BioMed Central Ltd. Research Open Access. The impact of surgical outcome after pancreaticoduodenectomy in elderly patients.

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World Journal of Surgical Oncology 9 Abstract Background The elderly population has increased in many countries. Patients and methods Subjects were 98 patients who underwent PD during the time period from April to April Results There was no statistical difference between patient groups in terms of gender, comorbidity, preoperative drainage, diagnosis, or laboratory data. Conclusion It cannot be ignored that the elderly population is getting larger.

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However in the contest of linearity and range test we verified that, for all cell subset used, the optimal counting cell concentration range is between and dilutions.

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Moreover matching all our accuracy, precision and linearity range data, we can conclude that the minimal and the maximal cells which can be counted are about from 30, to , cells respectively. FF: MD, Director. Bone marrow. Cell based medical products. Cell therapy products. Coefficient of variation. European community. European union. Good clinical practice. Good manufacturing practice.

International conference on harmonization Q2. Mononuclear cells. Mesenchymal stem cells. Peripheral blood. Standard deviation. Whole bone marrow. Whole peripheral blood. We are also grateful to Alessandra Mandese for data management and to Andrew Martin Garvey for editorial assistance. This article is published under license to BioMed Central Ltd. Methodology Open Access. Journal of Translational Medicine 10 Abstract Background The quality and safety of advanced therapy products must be maintained throughout their production and quality control cycle to ensure their final use in patients.

Methods As the cell count is a potency test, we checked accuracy, precision, and linearity, according to ICH Q2. Results All the tests performed met the established acceptance criteria of a coefficient of variation of less than ten percent. The cell count validation protocol was performed as shown in the flow chart Figure 1. The validation procedure was performed by two operators Op : Op1 and Op2.

Figure 1 Cell count validation protocol.

The cells were counted as reported in Figure 2 A. Depending on the focus adjustment of the microscope, the cells can be counted and seen as reflective spheres. The cells were counted as reported in Figure 2 B. Briefly, both operators counted the cells in 5 large squares, and calculated the average of the counts to reduce the margin of error.

In each large square, they counted all the cells contained in the 16 small squares, including the internal dividing lines. Accuracy As accuracy expresses the closeness of agreement between the value, which is accepted as either a conventional true value or as an accepted reference value and the value found, we decided that the use of MNCs was sufficient to validate this point of method.

All the data obtained are summarized in Figure 3. Figure 3 Accuracy. Op1 and Op2 performed the cell count three times. The cell viability was evaluated using Trypan Blue vital dye, with a dilution, as above described. These data demonstrated that the method is valid as it is both repeatable and precise. All the data are summarized in Figure 6. All the data are summarized in Figure 7. European Medicines Agency, Doc. Good manufacturing practices. ICH harmonized tripartite guideline validation of analytical procedures: text and methodology Q2 R1 ,. Electronic Signatures — Scope and Application,.

The International Society for Cellular Therapy position statement. Stem Cell International. Transfus Med Hemother.