Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)-a randomized phase II trial of the AIO pancreatic cancer group.

BACKGROUND: Data on perioperative chemotherapy in resectable pancreatic ductal adenocarcinoma (rPDAC) are limited. NEONAX examined perioperative or adjuvant chemotherapy with gemcitabine plus nab-paclitaxel in rPDAC (National Comprehensive Cancer Network criteria). PATIENTS AND METHODS: NEONAX is a prospective, randomized phase II trial with two independent experimental arms. One hundred twenty-seven rPDAC patients in 22 German centers were randomized 1 : 1 to perioperative (two pre-operative and four post-operative cycles, arm A) or adjuvant (six cycles, arm B) gemcitabine (1000 mg/m2) and nab-paclitaxel (125 mg/m2) on days 1, 8 and 15 of a 28-day cycle. RESULTS: The primary endpoint was disease-free survival (DFS) at 18 months in the modified intention-to-treat (ITT) population [R0/R1-resected patients who started neoadjuvant chemotherapy (CTX) (A) or adjuvant CTX (B)]. The pre-defined DFS rate of 55% at 18 months was not reached in both arms [A: 33.3% (95% confidence interval [CI] 18.5% to 48.1%), B: 41.4% (95% CI 20.7% to 62.0%)]. Ninety percent of patients in arm A completed neoadjuvant treatment, and 42% of patients in arm B started adjuvant chemotherapy. R0 resection rate was 88% (arm A) and 67% (arm B), respectively. Median overall survival (mOS) (ITT population) as a secondary endpoint was 25.5 months (95% CI 19.7-29.7 months) in arm A and 16.7 months (95% CI 11.6-22.2 months) in the upfront surgery arm. This difference corresponds to a median DFS (mDFS) (ITT) of 11.5 months (95% CI 8.8-14.5 months) in arm A and 5.9 months (95% CI 3.6-11.5 months) in arm B. Treatment was safe and well tolerable in both arms. CONCLUSIONS: The primary endpoint, DFS rate of 55% at 18 months (mITT population), was not reached in either arm of the trial and numerically favored the upfront surgery arm B. mOS (ITT population), a secondary endpoint, numerically favored the neoadjuvant arm A [25.5 months (95% CI 19.7-29.7months); arm B 16.7 months (95% CI 11.6-22.2 months)]. There was a difference in chemotherapy exposure with 90% of patients in arm A completing pre-operative chemotherapy and 58% of patients starting adjuvant chemotherapy in arm B. Neoadjuvant/perioperative treatment is a novel option for patients with resectable PDAC. However, the optimal treatment regimen has yet to be defined. The trial is registered with ClinicalTrials.gov (NCT02047513) and the European Clinical Trials Database (EudraCT 2013-005559-34).

[Prognostic factors in perforating diverticulitis of the large intestine]. / Prognosefaktoren der perforierten Dickdarmdiverticulitis.

Morbidity and mortality after emergency procedures in 105 patients with perforated colonic diverticulitis were evaluated in a retrospective study. In different stages of diverticulitis (Hinchey classification: I, 8.6%; II, 14.3%; III, 57.1%; IV, 20.0%) mortality was 12.4%. Preoperative sepsis syndrome with leucopenia and disturbed liver function, cardiac risk factors and obesity were independent prognostic factors in multiple logistic regression. Accompanied by immunosuppression the mortality rate remarkably increased to 33%. The stage of peritonitis showed no influence on the prognosis. In multivariate analysis, surgical procedure (primary resection 12.4%. Hartmann's procedure 61.9%, non-resection procedures 25.7%) showed influence only on increased general complications.

[Salmonella enteritidis infected false aneurysm of the superficial femoral artery in an HIV seropositive patient]. / Salmonella enteritidis infiziertes falsches Aneurysma der Arteria femoralis superficialis bei einem HIV-seropositiven Patienten.

In the course of an infection with human immunodeficiency virus, a large variety of complications affecting all organ systems can occur. However, complications affecting the vascular system demanding surgical intervention are rare. In the case presented we report a 67-year-old HIV-seropositive patient who underwent surgery for a huge abscess in the thigh. Intraoperatively unexpectedly we found a mycotic aneurysm of the femoral superficial artery and the causactive bacterium proved to be Salmonella enteritidis. Because of the rising number of HIV-infected patients we suspect that the amount of complications involving the vascular system and demanding surgical intervention will also increase. Therefore, when diagnosing and deciding on therapy for patients with AIDS, the physician must be aware that vascular complications due as a result of HIV infection might occur more frequently in the future.

[Colonic diverticulitis--therapy concepts from the surgical viewpoint]. / Colondivertikulitis--Therapiekonzepte aus chirurgischer Sicht.

Colon diverticulitis showed a great variability in kind, intensity and course of disease. Time and surgical procedure are dependent on the stage of diverticulitis (emergency procedure, elective resection, early elective resection). In emergency cases non-resecting procedures should not be performed. Here the Hartmann procedure and in favorable conditions the primary resection should be chosen. Other patients with acute diverticulitis should have early elective resection after short-term medical treatment (5-7 days). Patients with a chronic-recurrent course of disease should have an elective one-sided resection. The surgical principles are mobilization of the splenic flexure as well as the widening of the distal resection limit into the upper rectum to avoid a recurrence.

[Diagnosis of diverticulitis in routine practice: progress due to pelvic CT?]. / Die Diagnostik der Divertikulitis in der täglichen Routine: Fortschritt durch das Becken-CT?

In a retrospective study 243 pelvic CTs in patients with acute sigmoid diverticulitis and elective resections were analyzed. A statistical correlation of radiological and histological findings was performed. The sensitivity of the CT in diagnosing sigmoid diverticulitis was 97.5%; the overall accuracy of the pelvic CT was 97.1% in acute diverticulitis. For the contrast enema the sensitivity was 71.6% and the accuracy rate ranked 71.3%. The pelvic CT in patients with clinical suspicion of acute sigmoid diverticulities is well suited for a primary diagnostic tool and can precisely show the extraluminary extension of the inflammation.

[Varicose and ascending thrombophlebitis--surgical planning for emergency crossectomy by duplex ultrasound]. / Varikose und ascendierende Thrombophlebitis--Operationsplanung zur Notfallcrossektomie durch Duplexsonographie.

Ascending thrombophlebitis of the superficial leg veins is known to pass into the deep veins, causing an embolism to develop. Duplex ultrasonography has been shown to be a reliable technique for the evaluation of superficial venous thrombosis. If progression is noted, crossectomy proved to be effective in preventing passage of thrombi into the deep veins.

[Acute compartment syndrome of the tibia--complication of popliteal artery aneurysm]. / Das akute Compartmentsyndrom des Unterschenkels--Komplikation eines Aneurysma der A. poplitea.

The compartment syndrome is a common complication in the traumatology of the lower limb. In vascular surgery it is observed following emergency revascularisation. It is a rare condition as an initial symptom of a peripheral clotted aneurysm. By means of a case with a complicated popliteal aneurysm the differential diagnosis of the non-traumatologic compartment syndrome is discussed.

[Value of individually risk-adjusted after-care--economic management of oncologic effectiveness?]. / Stellenwert der individuellen risikoadaptierten Nachsorge--ökonomisches Handeln bei onkologischer Effektivität?

The individual risk-adapted follow-up programme after R0-resection of colorectal carcinoma is a propatiently and favourable alternative. Controlled economic studies are required to examine further quantitative and qualitative modifications of the follow-up programme.

[Slit drainage in hip endoprosthesis--also an alternative in trauma surgery? A prospective follow-up study]. / Die Slitdrainage in der Hüftendoprothetik--eine Alternative auch in der Unfallchirurgie? Eine prospektive Beobachtungsstudie.

Forty-four patients undergoing elective hip joint operation were analyzed to assess whether a new slit-suction drainage is less painful than the regular Redon-suction drainage. Main endpoint of the study was the effectiveness to draw off secretion and the pain at the time of removal of the drainage. Other endpoint was the rate of postoperative complications. At the time of removal patients with slit drain rarely complained about pain (p < 0.01). On contrary, patients with Redon drain always complained about pain. Clotting were seldom shown in slit drains and were frequently shown in Redon drains. Both slit drains and Redon drains were effective to drain secretion. As the new slit drain was more comfortable for patients following hip joint repair slit drain should always be used as suction drainage.

[Late abscess after laparoscopic cholecystectomy caused by lost gallstones]. / Spätabscess nach laparoskopischer Cholecystektomie durch verlorene Gallensteine.

A possible intraoperative complication of laparoscopic cholecystectomy is opening of the gallbladder with subsequent loss of gallstones. We report on a 61-year-old woman who was hospitalised with an obscure subhepatic tumor. Intraoperatively an abscess was found that had been caused by lost gallstones following after laparoscopic cholecystectomy 3 years previously. There is a low incidence of late abscesses caused by loss of gallstones, but because of the long latency and unspecific symptoms there may be problems in diagnosis. Taking into consideration possible complications caused by intraoperative loss of gallstones, all concrements should be retrieved, even though there is no indication for changing to an open procedure.

[Psychological stress on patients in tumor after-care after R0 resection of colorectal carcinomas]. / Die psychische Belastung von Patienten in der Tumornachsorge nach R0-Resektion colorectaler Carcinome.

In a prospective study 70 patients after curative resection for colorectal carcinoma were asked about the psychological strain in the follow-up program. Of these patients, 80.1% felt that they did the right thing and 70% were optimistic and confident regarding the follow-up examinations. Only 5 patients (7.1%) had no intention of keeping the follow-up appointment and 12 patients (17.1%) were thinking about recurrence. The patients were afraid of further examinations, and the majority (45 patients) hoped that further invasive examinations would not be necessary. Patients with a higher frequency of follow-up examinations did not report with more stress than patients fewer follow-up visits (P = 0.7 fisher exact). Older, single and female patients are special risk groups with a high level of psychological strain and should receive special attention within the follow-up (P < 0.08, fisher exact). In spite of the disappointing medical effectiveness of the regular follow-up program, psychological support in coping with cancer is the main result of regular follow-up visits to the hospital after curative resection of colorectal carcinoma and should be maintained.

[Systematic revision--a contribution to the treatment strategy of early infection in trauma surgery]. / Die planmässige Revision--ein Beitrag zur Behandlungsstrategie des Frühinfekts in der Unfallchirurgie.

Infections of the soft tissue and joint are the serious complication in traumatology. We are presenting our new surgical planned revision concept based on the clinical findings and the microbial sensitivity test. This concept shows that a number of radical debridements influencing by the local findings and the sterile results of 2 following cytologic smears led us to a higher certainty in healing surgical soft tissue and joint infection.

[Palliative surgical treatment of bone metastases. Improved quality of life by early intervention?]. / Palliative chirurgische Behandlung von Knochenmetastasen.

OBJECTIVE: To find out to what extent early operative treatment of osteolysis or pathological fractures, resulting from improved interdisciplinary treatment of malignant tumours, affects quality of life. PATIENTS AND METHOD: Using a standardised scheme of self-evaluation in a retrospective study, quality of life was assessed in 67 patients (18 men, 49 women; mean age 64.5 +/- 11.6 years) who were operated for osteolyses or pathological limb fractures due to malignant tumour metastases. RESULTS: Interlocking osteosynthesis was performed in 37 patients, endoprosthetic joint replacement in 30. Duration of operation and hospital stay were significantly shorter in those 17 patients operated for osteolysis than those 50 patients with a pathological fracture (P < 0.01 and P < 0.07, respectively). There were seven hospital deaths. Postoperative survival time averaged 13.4 months. 41 of the 60 patients discharged to outpatient follow-up were again capable of leading a normal life, 13 were clearly impaired, six required nursing care, 46 patients did not or only sporadically require analgesics postoperatively. CONCLUSION: Early operative treatment of osteolysis before the occurrence of fractures is justified by the low operative mortality and complication rates and the better quality of life that is achieved.

[Surgical treatment of diverticulitis of the large intestine--a plea for early elective resection]. / Die chirurgische Behandlung der Dickdarmdivertikulitis--Ein Plädoyer für die frühe elektive Resektion.

PURPOSE: Diverticulitis of the colon is observed more and more frequently in highly developed countries. The spontaneous course of the disease is not predictably; an exact definition of risk factors for perforated diverticulitis is missing. Therefore the decision for the conservative therapy or for an early elective resection is subject of a controversial discussion. The results of an offensive surgical concept, aiming at an early elective resection for definite therapy of diverticulitis have been analysed in a retrospective study. RESULTS: From 1980-1995 337 patients were operated due to diverticular disease (rate of resection: 98.8%). In spite of the increase of cases with severe complicated diverticulitis from 36.2% (1980-1985) to 45.8% (1991-1995; p = 0.05) the incidence of protective colostomies decreased from 18.8% in the first six years to 0.6% (n = 1) in the last 4 1/2 years (p < 0.001). After elective resection general complications occurred in 30.1% (n = 101), local complications in 17.0% (n = 57). The clinical anastomotic leakage rate was 2.1% (n = 7). During the study the morbidity rate decreased significantly (p < 0.005). Especially the incidence of nosocomial infections was reduced from 37.7% (1980-1985) to 14.8% (1991-1995); severe local complications (anastomotic leakage, bowel obstruction, peritonitis, hemorrhage, abscess) were reduced from 10.1% (1980-1985) to 3.2% (1991-1995). The mortality rate was 1.2% (n = 4). CONCLUSION: By consistent early elective resection of diverticulitis together with a standardized surgical management a definitive treatment of diverticulitis with a high and safe standard is possible. Already after the first severe attack of the disease, which leads to hospitalization, the early elective resection allows the definite cure for diverticular disease analogous to cholecystectomy or appendectomy, avoiding the life threatening complications.

[Maltose--an alternative in hypocaloric parenteral nutrition?]. / Maltose--eine Alternative in der hypokalorischen parenteralen Ernährung?

OBJECTIVE: The carbohydrate balance and nutritive efficacy of a completed nutritional solution with maltose were compared to an isocaloric completed nutritional solution with glucose by means of a hypocaloric parenteral nutrition after colorectal resections. METHODS: Prospective, randomised, double blind phase II trial (study group: maltose; control group: glucose). The infusion rate of maltose amounted to 0.05g maltose/kg body-weight/hour and was given postoperatively over 5 days by an infusion pump. RESULTS: Plasma glucose concentrations were similar low in both groups; indeed in the study group a significant higher renal carbohydrate loss of 7.1% was found compared to the control group with 0.4% (p < 0.001). In the study group three patients showed renal carbohydrate losses over 10% without finding a risk factor for these high renal losses. The cumulative nitrogen balance amounted to -3g N in both groups (p > 0.1). The labile plasma proteins in the 2 groups revealed almost identical concentration courses. No essential surgical complications occurred; no clinical side effect or incompatibility of the maltose solution were observed. CONCLUSION: Postoperative hypocaloric nutrition with maltose is possibly nutritive and energetic sufficient under conditions of a clinical study. Indeed, the deviations of the carbohydrate balance show the problems of the low and individual different metabolic capacity of maltose. Thus general use in daily routine seems not favourable due to the necessary precise management (application by infusion pump, daily quantitative examination of renal carbohydrate losses).

[Surgical therapy of sigmoid diverticulitis in elderly patients.--What decides against early elective resection]. / Die chirurgische Therapie der Sigmadivertikulitis beim alten Menschen.--Was spricht gegen die frühe elektive Resektion?

The results of an offensive surgical approach to diverticulitis, aimed at early elective resection, have been analysed retrospectively for 377 patients. 36.9% of older patients (> 74 years, n = 65) showed significantly higher general complications than younger patients (< 75 years, n = 312) with 26.9% (p = 0.03); local complications (18.3% vs. 12.3%; old vs. young) and mortality (1.5% vs. 1%) were similar. Age over 74 years was not a risk factor for a high morbidity and mortality in multivariate analysis. In order patients a definitive treatment for diverticular disease is also possible with high and safe standards due to early elective resection without high morbidity and mortality.

[Diverticulitis of the jejunum as a rare cause of acute gastrointestinal hemorrhage--diagnosis and therapy]. / Divertikulitis des Jejunums als seltene Ursache für eine akute gastrointestinale Blutung--Diagnostik und Therapie.

Small bowel diverticulosis is in contrast to large intestine diverticulosis an uncommon, acquired entity. In most cases it was found in duodenum and as a Meckel's diverticulum. Jejunal or ileal diverticulosis is a relatively rare disease. Although the majority of the patients do not require surgical treatment because of the absence of clinical signs, in 10% complications may necessitate small bowel resection. The clinical significance, diagnostic evaluation, and treatment of jejunal diverticular disease are reviewed.

[Acceptance and effectiveness of surgical vascular consultation--is it worthwhile?]. / Akzeptanz und Effektivität der chirurgischen Gefässsprechstunde--lohnt sich der Aufwand?

In a retrospective analysis the meaning of the vascular outpatient clinic and the follow-up after vascular reconstructive surgery were investigated. 6889 patients were checked within 8 1/2 years in the vascular consultant hour of the Marien-Hospital Düsseldorf with a fixed diagnostic schedule related to the vascular surgery. More than 40% of the patients did not have any vascular disease. Only 6.5% of the 276 patients with aortoiliac reconstructive surgery visited the follow-up terms regularly. The additional vascular training group was visited by only 1.2%. While 93 patients (33.7%) were hospitalized to further treatment because of new clinical findings, 54 patients got another vascular reconstruction and 12 patients were operated because of secondary disease. In 12 cases (10.5%) we found a clinical asymptomatic deterioration of the vascular status. The vascular consultant hour is time-consuming and expensive. The important task is the differentiation of vascular clinical findings. Although the acceptance and the effectiveness are disappointing the vascular outpatient clinic and the long-term follow-up after reconstructive vascular surgery is necessary for the improvement of the quality of care of the department and for acquiring new knowledge.