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).

[Transient paraplegia of the legs after sigmoid resection--late complication after implantation of an aortic bifurcation prosthesis in arterial occlusive disease?]. / Passagere Paraplegie der Beine nach Sigmaresektion--Spätkomplikation nach Implantation einer Aorten-Bifurkationsprothese bei arterieller Verschlusserkrankung?

Ischemic spinal lesions following graft replacement of an infrarenal aortic aneurysm are rare complications. Even more rare is the development of this complication in case of aortoiliac occlusive disease. We report one further case who developed transient paraplegia following sigma resection six years after implantation of an aortobifemoral bifurcation graft because of aortoiliac occlusive disease. The abdominal vessel and the collateral situation of this site of the caudal aorta is discussed and the possibility of late ischemic spinal lesions is pointed out.

[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.

[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.

[Gastrointestinal tuberculosis as a rare cause of perforation of the ileum]. / Die gastrointestinale Tuberkulose als seltene Ursache einer Perforation des Ileums.

The gastrointestinal tuberculosis is a rare disease and it can mimic a large variety of gastrointestinal diseases. The most common site of gastrointestinal tuberculosis is the ileocoecal region followed by the ascending colon and jejunum. Complications are an absolute indication for surgical intervention. Perforation is an extremely uncommon complication of mycobacterium tuberculosis infection.

[Slit drainage--progress in drainage treatment after herniotomy]. / Die Slitdrainage--ein Fortschritt in der Drainagebehandlung nach Herniotomie.

In a prospective randomized study was conducted on 80 patients undergoing elective hernia repair to assess whether a new slit-suction drainage is less painful than a Redon-suction drainage. Main endpoint of the study was the traction power in order to remove the drain. Other endpoints were pain at the time of removal of the drain and the effectiveness to draw off secretion. To remove redon drain the average traction power was 226 pond and to remove slit drain the average traction power was only 25 pond. The difference was significant (p less than 0.01). At the time of removal patients with slit drain rarely complained about pain (p less than 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 hernia repair slit drain should always be used as subcutaneous suction drainage.

[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.

[Is the surgeon a prognostically relevant factor after R0-resection of colorectal carcinoma?]. / Ist der Chirurg ein prognostisch relevanter Faktor nach R0-Resektion colorectaler Carcinome?

Although the principles of resection of colorectal carcinoma have been defined quite exactly, some studies report considerable variations in recurrence rate and survival between different surgeons and clinics. We have therefore evaluated whether this surgeon-related influence can be found within one surgical department if operative procedures are strictly standardized. The data of 651 patients who underwent R0-resection of colorectal carcinoma between 1980 and 1992 was evaluated. Since all resections were accomplished by 5 groups of surgeons who strictly obeyed the same principles of resection, patients were divided in 5 groups. These 5 groups showed similar distribution of age, sex, tumor location, operative procedures and UICC-tumor-stages. The locoregional recurrence rate ranged from 1.7%-13.3% in stage I (p > 0.05), 9.3-20.6% in stage II (p > 0.05) and 13.6-52.4% in stage III (p < 0.05). Metachronous distant metastases occurred in 3.2 to 13.3% in stage I (p > 0.05), 2.9 to 16.7% in stage II (p > 0.05) and 21.8 to 30.2% in stage III (p > 0.05). 5-year-survival-rates of the 5 groups of patients varied from 74.4-84.5% in stage I (p > 0.05), 61.6-76.8% in stage II (p > 0.05), and 38.1 to 57.7% in stage III (p < 0.05). Although the surgeon-related variability of these results was surprisingly high, multivariate analysis did not show the surgeon as a significant prognostic factor. If the same principles of resection are strictly obeyed within one department of surgery, the surgeon is not a factor of prognostic significance.(ABSTRACT TRUNCATED AT 250 WORDS)

[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.

[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.

[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.

[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.

[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.

[Late results of surgical treatment of Tossy III acromioclavicular joint separation with the Balser plate]. / Spätergebnisse nach operativer Behandlung der Schultereckgelenksprengung Tossy III durch die Balser-Platte.

Various surgical procedures have been recommended for the treatment of complete acromioclavicular joint separations. The results have been similar in case reports by various authors. From 1984 to 1992, 35 patients were operated on for acromioclavicular joint separations (Tossy III) in the Department of Surgery, Marien-Hospital, Düsseldorf, using Balser's hook plate. The postoperative morbidity rate was 14.3%. Follow-up examinations were performed on 30 patients (85.7%) with average follow-up of 4.1 years, using a rating system that include subjective, objective, and roentgenographic criteria. Fifty percent of patients had no complaints, but residual dislocation was found in 36.7% of cases. While 26 patients (86.7%) were satisfied with the results of the operation, 30% demonstrated a fair result according to the scoring system. The complaints and clinical findings showed no correlation with the X-ray results, e.g. calcification or arthrosis, redislocations.

[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.

[Inguinal hernia repair modified by Kirschner. A critical analysis after 11 years of clinical experience]. / Leistenhernienoperationen modifiziert nach Kirschner. Eine kritische Analyse nach 11 Jahren klinischer Erfahrung.

In a retrospective study the early and late complications and the recurrence rate of inguinal hernia 10 years after elective repair by a modification of Kirschner's procedure are presented and compared with those following other established surgical techniques. Questionnaires were sent to 1400 patients, and 1029 patients (73.5) also underwent clinical examination. With all techniques, the most frequent postoperative complications were haematomas and seromas (10.1%). Postoperative mortality was 0.2%. Late complications were reported by 36.4% of the patients followed up by questionnaire. The most frequently reported symptom (by 23.8%) was transitory hypaesthesia in the scar area. In 2.7% of the male patients examined testicular atrophy was found. All patients who reported a recurrence on their questionnaire underwent follow-up examination in the clinic. Thus, the cumulative recurrence rate was 9.6%. Over two-thirds of all recurrences were lateral recurrences (P < 0.01). It was not possible to determine potential risk factors for a recurrence of inguinal hernia. The recurrence rate increased with time before follow up: among the patients examined after 5 years the recurrence rate was 5.7%, while it was 12.1% for patients examined after a period of 10 years. Kirschner's modification involves a risk of lateral recurrence that should not be underestimated, and its use should be reconsidered. The Shouldice repair appears to be the method of choice. However, further results confirming this choice should be awaited.

[Preoperative hemodilution before elective resections of colorectal cancers for sparing homologous blood transfusion]. / Präoperative Hämodilution vor elektiven Resektionen kolorektaler Karzinome zur Einsparung von Fremdblut.

The records of 389 patients following elective resection of colorectal carcinoma were analysed in order to examine perioperative transfusion. Preoperative hemoglobin levels of 12.8 g/dl in women and 14.2 g/dl in men were found (p less than 0.01). Only 11% of the patients had an anemia. Increasing age and sex had both a significant relation to decreasing preoperative hemoglobin level and higher frequency of transfusion (p less than 0.01). Women got perioperative more often blood transfusion (84.4%). On an average 2.1 units of blood were transfused. There were no relation to tumor stage or tumor location be found (p greater than 0.01). 48.8% of the patients had attendant diseases. Cardiac insufficiency and pulmonary diseases became more frequent. Excluding all patients with contraindication to preoperative hemodilution it was possible to do preoperative hemodilution by 61.2% of the patients. In conclusion preoperative hemodilution should be done before elective resection of colorectal cancer if there was no contraindications to reduce the number of autologous blood transfusion.

[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.