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Background: Surgery is of increasing importance in the treatment and outcome of diseases of the pancreas worldwide. The incidence of pancreatic cancer (7-11/ 100,000 per year) has risen over the last years and surgical resection remains the only option for definite cure. Twenty-five percent of all resections are left of the superior mesenteric vein (distal pancreatectomy) and the appropriate closure technique for the pancreatic remnant remains unclear. Pancreatic fistulas are the most common (0-40%) and relevant postoperative complication. The optimal surgical strategy for pancreatic resection needs to be identified from the large number of surgical procedures available today., Purpose: To evaluate the effectiveness of the two most common surgical techniques for distal pancreatectomy: stapler versus hand-sewn closure of the pancreatic remnant., Methods: In order to account for the uncertainty and clinical heterogeneity in the management of the pancreatic remnant following distal pancreatectomy, a study protocol is developed on the basis of a retrospective survey of patients in a center of excellence for pancreatic surgery and a systematic review with meta-analysis., Results: The DISPACT trial is a multicentered, randomized, controlled and patient-and observer-blinded trial using a two-group parallel group-sequential superiority design to compare the two techniques mentioned above. It will include approximately 336 randomized patients at up to 20 centers of excellence in pancreatic surgery, who are undergoing elective distal pancreatectomy for resectable benign, malign, and neuroendocrine tumors, chronic pancreatitis and pseudocysts of the pancreatic body and tail. The combination of the rate of postoperative pancreatic fistula and mortality will be evaluated as the primary endpoint. In addition, a set of general and surgical parameters will be analyzed. Pre-specified treatment manuals and continuous intra-operative (photo-documentation of surgical procedures and blinded evaluation thereafter) and on-site monitoring will assure that the treatment of the study patients conforms to protocol and will minimize clinical heterogeneity. Due to uncertainties about the effect sizes of the primary endpoint, an a priori planned interim analysis of the primary endpoint will be conducted after 224 evaluable patients are selected in order to reassess the initially planned sample size., Limitations: Since pre-existing evidence was limited our initial sample size calculation is based on uncertain assumptions and may need to be modified in a planned interim analysis. Moreover, since surgical experience remains a potential confounder in surgical trials, learning curve bias has to be taken into account when analyzing the results. Given the participating trial sites, standardization of peri-and postoperative treatment represents a major issue of trial conduct., Conclusions: A group-sequential study design accounts for the uncertainty of pre-existing evidence. Also, standardization of surgical and postoperative care and blinded outcome assessment as well as adjustment for varying surgical expertise will contribute to a high validity and generalizability of the results.

Regardless of improved diagnostics and therapeutic options, complicated intraabdominal infections remain a challenge in medicine. The prognosis of secondary peritonitis depends upon diagnosis and therapy in time. Diagnostic gold-standard is the computed tomography enhanced by contrast medium. Antimicrobial and supportive therapy is initiated before surgery and should be continued throughout and after the operation. Surgery aims on clearing the focus with a one-step-procedure in order to reduce perioperative morbidity and mortality.

Background: Clinical research, especially the management of randomized controlled multicentre trials, is a challenge for surgical investigators. To provide the theoretical background and practical knowledge needed for surgical trials, it is necessary to revise standard training programmes, which focus on pharmacological research. The main differences concern regulatory aspects and content, especially in achieving and maintaining comparability, equal treatment, and outcome assessment using special randomisation techniques and standardised surgical procedures., Methods: In November 2005, in cooperation with the Coordinating Centre for Clinical Trials in Heidelberg, the Study Centre of the German Surgical Society Study Group (SDGC) hosted a clinical investigation course for surgeons. During 3 days, 24 participants were systematically instructed by 16 lecturers on clinical trials (planning, treatment by protocol, data management, biometrics, ethics, and law), followed by participants' evaluation of the course., Results: On a scale of 1 to 6 (excellent to insufficient, respectively) the mean grades for the course were 1.6 for content, 1.55 for clarity, and 1.55 for learning effect. Partial repetition, lack of work in small groups, and not enough materials to take home were the major criticisms., Conclusions: The evaluation emphasised the necessity and value of the course. Further courses with continued evaluation are necessary and can be based on the same underlying concept. However, the mere qualification of surgeons as clinical investigators without substantial additional improvements in structural problems and increased financial project support will not fundamentally improve clinical research in Germany.

Cross-sectional imaging based on navigation and virtual reality planning tools are well-established in the surgical routine in orthopedic surgery and neurosurgery. In various procedures, they have achieved a significant clinical relevance and efficacy and have enhanced the discipline's resection capabilities. In abdominal surgery, however, these tools have gained little attraction so far. Even with the advantage of fast and high resolution cross-sectional liver and pancreas imaging, it remains unclear whether 3D planning and interactive planning tools might increase precision and safety of liver and pancreas surgery. The inability to simply transfer the methodology from orthopedic or neurosurgery is mainly a result of intraoperative organ movements and shifting and corresponding technical difficulties in the on-line applicability of presurgical cross sectional imaging data. For the interactive planning of liver surgery, three systems partly exist in daily routine: HepaVision2 (MeVis GmbH, Bremen), LiverLive (Navidez Ltd, Slovenia) and OrgaNicer (German Cancer Research Center, Heidelberg). All these systems have realized a half- or full-automatic liver-segmentation procedure to visualize liver segments, vessel trees, resected volumes or critical residual organ volumes, either for preoperative planning or intraoperative visualization. Acquisition of data is mainly based on computed tomography. Three-dimensional navigation for intraoperative surgical guidance with ultrasound is part of the clinical testing. There are only few reports about the transfer of the visualization of the pancreas, probably caused by the difficulties with the segmentation routine due to inflammation or organ-exceeding tumor growth. With this paper, we like to evaluate and demonstrate the present status of software planning tools and pathways for future pre- and intraoperative resection planning in liver and pancreas surgery.

Over many decades the surgical treatment of gastrointestinal tumours was limited to cases of manifest malignancy and was performed with curative or palliative intent. Molecular diagnostics have now led to an optimised characterisation of different sporadic and hereditary tumour entities. Furthermore, a number of diseases which are an obligatory precancerosis or which carry a very high risk of cancer in their long courses have now been identified. Parallel to these developments, a dramatic reduction of morbidity has been achieved in major abdominal surgery due to more subtle and blood-sparing surgical techniques and mortality has been reduced to a minimum even in the most major procedures. This combination nowadays safely allows preventive or preventive extended surgical measures in cases where interventional therapy cannot be adequately employed.

Purpose: To evaluate multislice-CT versus MRI in the diagnosis and staging of pancreatic carcinoma in a prospective multi-reader analysis., Materials and Methods: Fifty patients with suspected pancreatic carcinoma underwent both multislice-CT (4-Row, "hydro-technique") and state-of-the-art MRI (two 1.5 T units). In correlation with histopathologic findings or in case of a non-lesion diagnosis by follow-up (6-month interval), we evaluated MRI versus CT in a multi-reader analysis (2 reader pairs) for: 1. diagnostic quality; 2. examination time; 3. accuracy of potential resectability; 4. kappa analysis of observer variations; and 5. overall diagnostic reliability., Results: A total of 28 lesions (n = 22 malignant, n = 6 benign) were present in the cohort group versus 22 patients without a focal lesion (n = 10 pancreatitis, n = 12 no tumor). For lesion detection, CT had a sensitivity of 100/89 % (reader pair 1/2) and specificity of 77 %, and MRI had a sensitivity of 75/89 % and specificity of 77/73 %. For the subgroup of adenocarcinomas of the pancreas (n = 17), we found a sensitivity of 100 % and a specificity of 61 % for CT versus a sensitivity of 82/94 % and a specificity of 67/61 % for MRI. The accuracy for determining the resectability was 91/82 % for CT and 90/82 % for MRI. The kappa analysis showed a good correlation for CT (0.71) and a moderate correlation of both groups for MRI (0.49)., Conclusion: CT and MRI showed comparable results in the detection of pancreatic carcinomas as well as in the determination of resectability. Chronic pancreatitis as a "tumor-like-lesion" was the major factor of a missed diagnosis. The results of multi-reader analysis for both reading groups were almost identical with a moderate to good kappa correlation. There is no reason to prefer MRI (more expensive) over CT for patients with the presumptive diagnosis of pancreatic cancer.

Transferrin receptor (TFRC) is a membrane-bound protein expressed in larger amounts in proliferating, e.g., malignant, cells than in quiescent cells. The specific expression of TFRC can represent a diagnostic tool or a therapeutic target in solid tumours expressing this antigen. Whether TFRC is expressed in human pancreatic tumours is unknown. The aim of this study was the investigation of the expression of TFRC and transferrin in human pancreatic cancer and in neuroendocrine tumours of the pancreas. Fifty one specimens of human pancreatic cancer and 14 samples of pancreatic neuroendocrine tumours were obtained after surgery. The expression of TFRC, transferrin and cytokeratin was studied by standard immunohistochemistry. Flow cytometry was used for the investigation of TFRC expression in nine cell lines of ductal pancreatic cancer in vitro. In contrast to normal tissue, 93% of pancreatic tumour cells showed positive (82%) or heterogeneous (11%) expression of TFRC. It was strongly expressed by malignant epithelial cells; normal stromal and endothelial cells were not stained by anti-TFRC antibodies. Primary tumours and metastases showed a similar frequency of TFRC expression. Three neuroendocrine carcinomas showed positive expression of TFRC by malignant tumour cells. The expression of TFRC was negative in benign neuroendocrine tumours of the pancreas. The cell lines of pancreatic cancer were characterised by a low expression of TFRC in vitro. In contrast to normal pancreatic tissue and benign neuroendocrine tumours of the pancreas, pancreatic cancer and neuroendocrine carcinoma are therefore characterised frequently by high expression of TFRC. Hence, TFRC represents a marker of malignant transformation in the pancreas that could be applied as potential diagnostic and therapeutic target.